Clinical trial support system, clinical trial support method, and clinical trial support program

Abstract

To provide a system that enables both trial participants and management institutions to work efficiently with simple processes throughout the entire flow of a clinical trial, and enables tasks at each step of the clinical trial for each trial participant to be performed reliably for the same trial participant. [Solution] The clinical trial support system 1 comprises an application input reception unit 2 that receives input of applications to participate in a clinical trial, a clinical trial process start recording unit 3 that identifies the clinical trial participant using terminal-acquired data obtained from the user terminal of the clinical trial participant at the start of each clinical trial process in the clinical trial, accepts input of identification data, and, if the participant is authenticated based on the identification data, records clinical trial process start data indicating the start of the corresponding clinical trial process, and a clinical trial process completion recording unit 4 that identifies the clinical trial participant using terminal-acquired data at the end of each clinical trial process, and records clinical trial process completion data indicating the end of the corresponding clinical trial process.

Description

[Technical Field]

[0001] The present invention relates to a technology for supporting clinical trials using a computer system. [Background technology]

[0002] Clinical trials are clinical trials conducted to confirm the efficacy and safety of drugs, quasi-drugs, medical devices, medical applications (medical software), health foods (nutritional functional foods, foods for specified health uses, foods with functional claims), supplements (nutritional supplements), health foods, cosmetics, etc. (hereinafter referred to as drugs, etc.) For example, an organization that develops, manufactures, or sells drugs, etc. may act as a clinical trial sponsor and request a hospital or other medical institution to conduct the clinical trial.

[0003] Japanese Patent Publication No. 2011-233066 (Patent Document 1) discloses a subject recruitment and selection method using a computer to enable an intermediary who introduces subjects who meet the selection criteria for a clinical trial to a clinical trial sponsor to recruit and select subjects via the Internet.

[0004] Japanese Patent Application Laid-Open Publication No. 2003-203120 (Patent Document 2) discloses a clinical trial information management system comprising a clinical trial site computer and a clinical trial information management computer. The clinical trial site computer transmits clinical trial result information to the clinical trial information management computer. The clinical trial information management computer determines whether the personal information in the pre-stored clinical trial registration information matches the personal information in the clinical trial result information, and if they do not match, outputs confirmation information notifying the user that the clinical trial result information contains suspicious data that may be erroneous.

[0005] Japanese Patent Laid-Open Publication No. 2003-203122 (Patent Document 3) also discloses a clinical trial information management system comprising a trial site computer and a clinical trial information management computer. The clinical trial information management computer receives and stores test completion information indicating that a test has been completed from the trial site computer, along with a subject identification identifier and test identification. If no test completion information corresponding to a combination of subject identification identifier and test identification where the scheduled test implementation time is before a predetermined period has passed is stored, progress warning information is sent to the trial site computer. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] Japanese Patent Application Laid-Open No. 2011-233066 [Patent Document 2] Japanese Patent Application Laid-Open No. 2003-203120 [Patent Document 3] Japanese Patent Application Laid-Open No. 2003-203122 Summary of the Invention [Problem to be solved by the invention]

[0007] The flow of a clinical trial when a clinical trial participant takes part is, for example, as follows: (1) A person wishing to take part in the clinical trial learns about the recruitment of participants and applies to take part in the clinical trial. (2) The clinical trial participant undergoes a screening test to determine whether or not they are suitable for the clinical trial. (3) They take the main test of the clinical trial. (4) After the main test, they undergo outpatient tests. (5) They receive payment for their cooperation in the clinical trial.

[0008] In many cases, the institutions that carry out each of these steps (1) to (5) are different. For example, in some cases, the acceptance of participation applications (1) is carried out by an intermediary (participation recruitment institution) that specializes in recruiting clinical trial participants, the actual test (2) to (4) and the tests before and after the test are carried out at one or more medical institutions that are the clinical trial institutions, and the cooperation costs (5) are borne by the pharmaceutical company that is the institution requesting the clinical trial, and payment is made at the medical institution where the final test is carried out.

[0009] In such cases, clinical trial participants must communicate with different organizations at each stage to complete various procedures and tasks. Furthermore, the recruitment organization, clinical trial organization, and clinical trial sponsoring organization each communicate with participants and manage the progress and results of the clinical trial. Therefore, each organization must separately and appropriately manage the personal information of clinical trial participants, while also ensuring that each step of the process is carried out for the same individual to prevent impersonation or substitute testing.

[0010] Furthermore, participants who have taken part in one clinical trial must wait a certain period of time, i.e., a drug-withdrawal period, before they can take part in the next trial. This drug-withdrawal period must also be checked by both the participant recruitment organization and the clinical trial organization.

[0011] In view of the above situation, the present application discloses a clinical trial support system, a clinical trial support method, and a clinical trial support program that enable both clinical trial participants and management institutions to work efficiently with simple processes throughout the entire flow of one or more clinical trials, and that enable tasks at each stage of the clinical trial for each clinical trial participant to be performed reliably for the same clinical trial participant. [Means for solving the problem]

[0012] A clinical trial support system according to an embodiment of the present invention comprises: an application input receiving unit that receives an application to participate in a clinical trial via the user terminal of the clinical trial participant and records the clinical trial participant ID of the clinical trial participant in a memory unit in association with a clinical trial ID that identifies the clinical trial; a clinical trial process start recording unit that, at the start of each clinical trial process in the clinical trial identified by the clinical trial ID, identifies the clinical trial participant using terminal-acquired data acquired from the user terminal of the clinical trial participant, accepts input of identification data including personal information based on the identification card brought by the clinical trial participant, and, if the participant is authenticated based on the identification data, records clinical trial process start data indicating the start of the corresponding clinical trial process in the memory unit in association with the clinical trial participant ID; The clinical trial process completion recording unit is provided with: at the end of each clinical trial process in the clinical trial identified by the clinical trial ID, the clinical trial participant is identified using terminal-acquired data acquired from the user terminal of the clinical trial participant; and clinical trial process completion data indicating the end of the corresponding clinical trial process is recorded in the memory unit in association with the clinical trial participant ID. [Brief explanation of the drawings]

[0013] [Figure 1] FIG. 1 is a diagram showing an example of the configuration of a clinical trial support system according to an embodiment of the present invention. [Figure 2] FIG. 2 shows an example of the configuration of the user terminal shown in FIG. 1. [Figure 3] A sequence diagram showing an example of the operation of the clinical trial support system shown in Figure 1 [Figure 4] A diagram showing an example of clinical trial process start data and clinical trial process end data [Figure 5] A flowchart showing an example of the operation of the user terminal shown in FIG. 1. DETAILED DESCRIPTION OF THE INVENTION

[0014] (Configuration 1) A clinical trial support system according to an embodiment of the present invention comprises: an application input receiving unit that receives an application to participate in a clinical trial via the user terminal of the clinical trial participant and records the clinical trial participant ID of the clinical trial participant in a memory unit in association with a clinical trial ID that identifies the clinical trial; a clinical trial process start recording unit that, at the start of each clinical trial process in the clinical trial identified by the clinical trial ID, identifies the clinical trial participant using terminal-acquired data acquired from the user terminal of the clinical trial participant, accepts input of identification data including personal information based on the identification card brought by the clinical trial participant, and, if the participant is authenticated based on the identification data, records clinical trial process start data indicating the start of the corresponding clinical trial process in the memory unit in association with the clinical trial participant ID; The clinical trial process completion recording unit is provided with: at the end of each clinical trial process in the clinical trial identified by the clinical trial ID, the clinical trial participant is identified using terminal-acquired data acquired from the user terminal of the clinical trial participant; and clinical trial process completion data indicating the end of the corresponding clinical trial process is recorded in the memory unit in association with the clinical trial participant ID.

[0015] According to the clinical trial support system of the above configuration 1, a clinical trial participant can easily apply to participate in a clinical trial and complete the procedures for starting and ending each clinical trial step via a user terminal. Furthermore, the clinical trial management institution can easily and reliably accept applications and perform identity verification and recording at the start and end of each clinical trial step via the user terminal. In particular, at the start of each step, in addition to authenticating the user terminal, identity authentication processing is performed using identification data based on the identification card brought by the clinical trial participant, ensuring that the same person is participating in each step. As a result, both the clinical trial participant and the management institution can work efficiently with simple processing throughout the entire flow of one or more clinical trials, and the tasks for each step of the clinical trial for each clinical trial participant can be reliably performed for the same clinical trial participant.

[0016] The clinical trial process in one clinical trial includes, for example, at least a main test process, and further includes at least one of a pre-main test test and a post-main test test, as necessary. The main trial is a clinical trial conducted on trial participants using a pharmaceutical product or other substance that is the target of the clinical trial. A single clinical trial often includes multiple clinical trial processes. When a single clinical trial includes multiple clinical trial processes, for each of the multiple clinical trial processes, the clinical trial process start recording unit records clinical trial process start data, and the clinical trial process end recording unit records clinical trial process end data. The clinical trial processes in a single trial may be set appropriately depending on the content of the clinical trial. For example, a single clinical trial process may be a process performed during a single visit by a clinical trial participant to a clinical trial site or a process performed in a single day, or a single ingestion or use of a pharmaceutical product or other substance. A single clinical trial process may also include multiple clinical trial processes. Similarly, a single pre-main test test and / or a single post-main test test may include multiple clinical trial processes.

[0017] The process of identifying a clinical trial participant using device-acquired data acquired from a user terminal may be, for example, a process of authenticating a clinical trial participant, who is the user of the user terminal, based on the device-acquired data acquired from the user terminal. The device-acquired data may be data unique to the user terminal, i.e., data unique to the user. The process of identifying a user may be, for example, a process of identifying a user using a user ID, a user ID and password, a telephone number, a one-time password, etc. The clinical trial support system may acquire the device-acquired data from the user terminal, for example, by communicating with the user terminal via wired or wireless communication, reading a two-dimensional code displayed on the user terminal, or by the user terminal transmitting the results of reading a two-dimensional code output from the clinical trial support system. The process of identifying a clinical trial participant may be, for example, performed by comparing the device-acquired data acquired from the user terminal with data of the clinical trial participant pre-recorded in the storage unit.

[0018] The personal authentication process may be a process of determining whether or not personal authentication is possible based on whether or not personal information recorded in the storage unit matches personal information in the input identification data, for example. The clinical trial process start recording unit may accept the input of the identification card data as input from a staff member of the clinical trial site. This inputs the identification card information confirmed by the staff member of the clinical trial site. That is, the identification card information confirmed by a third party is input. The personal information in the identification card data may be the information recorded on the identification card itself, such as name, date of birth, address, various identification card numbers, and facial photograph. Alternatively, the personal information in the identification card data may be information indicating that the information recorded on the identification card matches the personal information of the clinical trial participant pre-recorded in the storage unit, and may be information entered by a person other than the clinical trial participant (e.g., a staff member). In the former case, the identity of the clinical trial participant is authenticated when the personal information in the identification card data matches the pre-recorded personal information of the clinical trial participant. In the latter case, the identity of the clinical trial participant is authenticated by inputting the identification card data by a person other than the clinical trial participant. Alternatively, the identity authentication process may be performed by comparing a facial image of the clinical trial participant taken by a camera with the facial photograph image on the ID card.

[0019] (Configuration 2) In the above configuration 1, the clinical trial support system may further include a drug holiday determination unit that acquires information identifying a clinical trial participant and determines a drug holiday period during which the clinical trial participant cannot participate in the clinical trial based on at least one of the clinical trial process start data and the clinical trial process end data of the most recent past clinical trial in which the clinical trial participant identified by the information participated.

[0020] This makes it possible to determine the drug holiday period based on information indicating the start or end of the clinical trial process of the most recent clinical trial in the trial participant's past. Therefore, checking the drug holiday period can be performed using a simple process. The drug holiday period determination unit may output, for example, information indicating the drug holiday period of the trial participant as a determination result. Alternatively, the drug holiday period determination unit may output, as a determination result, information indicating whether the implementation period of the clinical trial in which the trial participant is to participate or start overlaps with the drug holiday period. The implementation period of the clinical trial in which the trial participant is to participate or start may be, for example, the medication period in the clinical trial, the entire period during which the clinical trial is conducted, or the period of the clinical trial process including medication. Information indicating the implementation period of the clinical trial in which the trial participant is to participate or start is included, for example, in clinical trial information recorded in association with the clinical trial ID.

[0021] The drug withdrawal period determination unit may determine the drug withdrawal period of the clinical trial participant, for example, at the time of accepting the input of the application to participate in the clinical trial or the start of the clinical trial process, based on at least one of the clinical trial process start data and clinical trial process end data of the most recent past clinical trial in which the clinical trial participant who is applying to participate or who is about to start the clinical trial process participated. This allows the drug withdrawal period of the clinical trial participant who is applying to participate or who is about to start the clinical trial process to be checked by a simple process at the time of applying for the clinical trial or the start of the clinical trial process. For example, the drug withdrawal period determination unit can determine whether the implementation period of the clinical trial for which the clinical trial participant is applying to participate or the clinical trial process that is about to start overlaps with the drug withdrawal period of the clinical trial participant.

[0022] If the drug holiday period determination unit determines that the implementation period of the clinical trial to be participated in or to be started overlaps with the drug holiday period of the clinical trial participant, the drug holiday period determination unit may notify the user terminal of the clinical trial participant that the clinical trial participant cannot participate in the clinical trial. In other words, if the drug holiday period determination unit determines that the implementation period of the clinical trial overlaps with the drug holiday period of the clinical trial participant, the clinical trial support system can refuse participation so that the clinical trial participant cannot participate in the clinical trial.

[0023] For example, the clinical trial process start data may include information indicating the start time of the clinical trial process, and the clinical trial process end data may include information indicating the end time of the clinical trial process. In this case, the drug holiday period determination unit may determine the drug holiday period of the clinical trial participant based on at least one of the start time of the clinical trial process indicated by the clinical trial process start data and the end time of the clinical trial process indicated by the clinical trial process end data.

[0024] For example, the drug holiday period determination unit can determine the start time (e.g., the start date) of the drug holiday period based on at least one of the clinical trial process start data and the clinical trial process end data in the most recent clinical trial of the clinical trial participant, and the period from the start time until a predetermined period has elapsed can be set as the drug holiday period. The method for determining the start time of the drug holiday period and the length of the period may be determined, for example, according to at least one of the clinical trial in which the clinical trial participant most recently participated and the clinical trial in which the clinical trial participant is about to participate or start.

[0025] The drug suspension period determination unit may determine the drug suspension period of the clinical trial participant by further using at least one of the clinical trial information stored in the storage unit in association with the clinical trial ID of the most recent clinical trial and the clinical trial information stored in the storage unit in association with the clinical trial ID of the clinical trial in which the clinical trial participant is to participate or start. The clinical trial information used to determine the drug suspension period may include, for example, the drug or the like that is the subject of the clinical trial, or the implementation period of the clinical trial (such as the drug administration schedule in the clinical trial).

[0026] The clinical trial support system may further include a drug holiday information providing unit that receives a request to inquire about an individual's drug holiday period together with data that identifies the individual, and outputs a determination result of the drug holiday period based on at least one of the clinical trial process start data and the clinical trial process end data in the most recent past clinical trial of the clinical trial participant corresponding to the individual, which are recorded in a memory unit.

[0027] The clinical trial support system may include a clinical trial participation information receiving unit that receives input of clinical trial participation information for clinical trials in which the clinical trial participant has previously participated, and records the clinical trial participation information in the storage unit in association with the clinical trial participant ID of the clinical trial participant. The drug holiday period determination unit or the drug holiday period information providing unit may determine a drug holiday period for the clinical trial participant based on the clinical trial participation information.

[0028] (Configuration 3) In the above configuration 1 or 2, the clinical trial support system may further comprise a cooperation cost calculation unit that calculates the clinical trial cooperation costs for the clinical trial participants based on the clinical trial process start data and the clinical trial process end data. This allows the clinical trial cooperation costs for the clinical trial participants to be appropriately calculated depending on the participation status of each process of the clinical trial.

[0029] Clinical trial cooperation costs are costs paid to clinical trial participants, and are sometimes referred to as honorarium or burden reduction costs. Typically, cooperation costs are borne by the institution sponsoring the clinical trial, such as a pharmaceutical company. In addition to the institution sponsoring the clinical trial, it is also expected that clinical trial cooperation costs will be borne by other parties, such as the provider of the clinical trial support system. In this case, the cooperation cost calculation unit can calculate the share of the cooperation costs borne by each of the multiple parties.

[0030] In any of the above configurations 1 to 3, the clinical trial support system may further include a participant evaluation unit that calculates an evaluation value of the clinical trial participant based on at least one of the clinical trial process start data and the clinical trial process end data. This allows the clinical trial participant to be evaluated according to their participation status in each clinical trial process. The cooperation cost calculation unit may calculate the clinical trial cooperation cost based on the evaluation value of the participant evaluation unit.

[0031] The clinical trial support system may notify the user terminal of the clinical trial participant of information related to the clinical trial for the clinical trial participant based on at least one of the clinical trial process start data and the clinical trial process end data, thereby enabling notification of the information related to the clinical trial at an appropriate time according to the progress of the clinical trial process of the clinical trial participant.

[0032] A clinical trial support method according to an embodiment of the present invention includes the following steps executed by a computer: an application input receiving step of receiving an application to participate in a clinical trial via a user terminal of the clinical trial participant, and recording the clinical trial participant ID of the clinical trial participant in a storage unit in association with a clinical trial ID that identifies the clinical trial; a clinical trial process start recording step, which, at the start of each clinical trial process in the clinical trial identified by the clinical trial ID, identifies the clinical trial participant using terminal-acquired data acquired from the user terminal of the clinical trial participant, accepts input of identification data including personal information based on the identification card brought by the clinical trial participant, and, if the participant is authenticated based on the identification data, records clinical trial process start data indicating the start of the corresponding clinical trial process in the memory unit in association with the clinical trial participant ID; a clinical trial process completion recording step for identifying the clinical trial participant using terminal-acquired data acquired from the user terminal of the clinical trial participant at the end of each clinical trial process in the clinical trial identified by the clinical trial ID, and recording clinical trial process completion data indicating the completion of the corresponding clinical trial process in the memory unit in association with the clinical trial participant ID; It has.

[0033] A clinical trial support program according to an embodiment of the present invention includes: an application input acceptance process for accepting an application to participate in a clinical trial via the user terminal of the clinical trial participant, and recording the clinical trial participant ID of the clinical trial participant in a storage unit in association with a clinical trial ID that identifies the clinical trial; a clinical trial process start recording process that, at the start of each clinical trial process in the clinical trial identified by the clinical trial ID, identifies the clinical trial participant using terminal-acquired data acquired from the user terminal of the clinical trial participant, accepts input of identification data including personal information based on the identification card brought by the clinical trial participant, and, if the participant is authenticated based on the identification data, records clinical trial process start data indicating the start of the corresponding clinical trial process in the memory unit in association with the clinical trial participant ID; a clinical trial process completion recording process that, at the end of each clinical trial process in the clinical trial identified by the clinical trial ID, identifies the clinical trial participant using terminal-acquired data acquired from the user terminal of the clinical trial participant, and records clinical trial process completion data indicating the end of the corresponding clinical trial process in the memory unit in association with the clinical trial participant ID; to be executed by the computer.

[0034] A user terminal capable of data communication with the clinical trial support system of the above configurations 1 to 3 is also included in the embodiments of the present invention. a clinical trial participation application unit that supplies participation application data including the clinical trial in which the clinical trial participant wishes to participate and the clinical trial participant based on input from the clinical trial participant to the clinical trial support system; a clinical trial process initiation unit that, when detecting the start of the clinical trial process of the clinical trial based on input from the clinical trial participant or information acquired from the clinical trial support system, supplies terminal-acquired data for identifying the clinical trial participant to the clinical trial support system; and a clinical trial process completion unit that, when the completion of the clinical trial process of the clinical trial is detected based on input from the clinical trial participant or information acquired from the clinical trial support system, supplies the clinical trial support system with terminal-acquired data for identifying the clinical trial participant.

[0035] An embodiment of the present invention also includes a program that causes a user terminal capable of data communication with the clinical trial support system to execute processing. a clinical trial participation application process that provides the clinical trial support system with participation application data including the clinical trial in which the clinical trial participant wishes to participate and the clinical trial participant based on input from the clinical trial participant; a clinical trial process initiation process that, when the start of the clinical trial process of the clinical trial is detected based on input from the clinical trial participant or information acquired from the clinical trial support system, supplies terminal-acquired data for identifying the clinical trial participant to the clinical trial support system; When the end of the clinical trial process of the clinical trial is detected based on input from the clinical trial participant or information obtained from the clinical trial support system, the user terminal executes a clinical trial process end process that supplies terminal-acquired data for identifying the clinical trial participant to the clinical trial support system.

[0036] (System configuration example) FIG. 1 is a diagram showing an example of the configuration of a clinical trial support system according to an embodiment of the present invention. The clinical trial support system 1 records data for clinical trial support in a memory unit 9 by communicating with a user terminal 10 of a clinical trial participant or a terminal 11 of a clinical trial site at each stage of the flow of one or more clinical trials. This allows for efficient accumulation of data necessary for clinical trial support. The clinical trial support system 1 provides clinical trial support services to both clinical trial participants and the institutions running the clinical trial. The clinical trial support system 1 includes an application reception unit 2, a clinical trial process start recording unit 3, a clinical trial process completion recording unit 4, a drug holiday determination unit 5, a cooperation cost calculation unit 6, a participant evaluation unit 7, a drug holiday information provision unit 81, and a clinical trial participation information reception unit 82. The clinical trial support system 1 can access the data in the memory unit 9. Furthermore, the clinical trial support system 1 can communicate with the user terminal 10, the terminal 11 of a clinical trial site, and an accounting system 13, for example, via a network.

[0037] The application reception unit 2 accepts input of an application to participate in a clinical trial via the user terminal 10 of the clinical trial participant. The data input in the application includes, for example, information identifying the clinical trial in which the participant wishes to participate and information identifying the clinical trial participant. At the time of application for participation in a clinical trial, the subject of the application is the person wishing to participate in the clinical trial, but in this application, the person wishing to participate in the clinical trial will also be referred to as the clinical trial participant. Based on the input, the application reception unit 2 associates the clinical trial participant ID of the clinical trial participant with the clinical trial ID of the clinical trial in which the participant wishes to participate and records it in the memory unit. The clinical trial participant ID is information for uniquely identifying the clinical trial participant, and there are no particular restrictions on the format.

[0038] For example, a trial participant may have an account for using the trial participant services of the clinical trial support system 1. In this case, the trial participant's account information (e.g., user ID and password) is recorded in the storage unit 9. Alternatively, an external authentication system (authentication server) may be used to perform user authentication based on the trial participant's account. For example, the trial participant ID may be the user ID of the account.

[0039] The clinical trial participant ID may be recorded in association with terminal identification data that identifies the user terminal 10 of the clinical trial participant. For example, the account information of the clinical trial participant may include the terminal identification data of the clinical trial participant. The terminal identification data may be, for example, the telephone number or hardware identification information of the user terminal 10. For example, when the clinical trial support system 1 identifies the clinical trial participant using terminal acquisition data acquired from the user terminal, in addition to user authentication using the account information of the clinical trial participant, it can perform terminal authentication of the user terminal 10 of the clinical trial participant using the terminal identification data. In this case, it can be guaranteed that the same clinical trial participant uses the same user terminal with a unique account. Note that the terminal authentication function may be omitted. In this case, the clinical trial participant can use the clinical trial support system 1 using multiple different user terminals.

[0040] The application reception unit 2 may display information about clinical trials for which participation applications are available on the user terminal 10. It may also accept selection of a clinical trial in which a clinical trial participant wishes to participate from among the clinical trials displayed on the user terminal 10. The application reception unit 2 may extract clinical trial information for clinical trial IDs pre-recorded in the storage unit 9, the corresponding clinical trial information of which satisfies the conditions, and display this information on the user terminal 10 as information about clinical trials for which participation applications are available. The application reception unit 2 may also accept input of search conditions for clinical trials via the user terminal 10, extract information about clinical trials that satisfy the search conditions from the storage unit 9, and display it on the user terminal 10.

[0041] The memory unit 9 stores a clinical trial ID that identifies the clinical trial, and clinical trial information associated with the clinical trial ID. The clinical trial information stored in association with the clinical trial ID may include, for example, information regarding the content of the clinical trial (drugs, etc.), the trial period, the schedule of each clinical trial step, the trial institution, the trial location, the recruitment period, the drug holiday period, the number of participants to be recruited, and the cooperation fee (reward). A clinical trial participant can input, via the user terminal 10, at least one of the trial period, the trial location, the drug holiday period, and the cooperation fee as search conditions for the clinical trial. The application receiving unit 2 can extract from the memory unit 9 the clinical trial information for clinical trials that meet the input search conditions, and display it on the user terminal 10.

[0042] The application reception unit 2 may receive input of responses from the clinical trial participant to an initial questionnaire regarding the clinical trial in which they wish to participate. The responses to the initial questionnaire are recorded in the memory unit, for example, in association with the clinical trial ID and the clinical trial participant ID. The clinical trial support system 1 provides the results of the responses to the initial questionnaire to the implementing institution or the clinical trial sponsoring institution, and receives input of participation approval from the implementing institution or the clinical trial sponsoring institution. When participation approval is input, participation in the clinical trial desired by the clinical trial participant is decided, and this fact is recorded in the memory unit 9.

[0043] The clinical trial process start recording unit 3 executes a process for identifying the clinical trial participant and a process for authenticating the identity of the clinical trial participant at the start of each clinical trial process, and when the identity of the participant is authenticated, records clinical trial process start data indicating the start of the clinical trial process in the memory unit 9 in association with the clinical trial participant ID. The process for identifying the clinical trial participant is executed using terminal-acquired data acquired from the user terminal 10 at the start of the clinical trial process. The terminal-acquired data may include, for example, data for identifying the clinical trial participant and data for authentication such as a one-time password.

[0044] As an example of how the clinical trial support system 1 acquires terminal-acquired data, the user terminal 10 can read a two-dimensional code issued by the clinical trial support system 1, and an application on the user terminal 10 can decode the two-dimensional code and transmit the terminal-acquired data containing information to the clinical trial support system 1. The two-dimensional code may include, for example, a one-time password or information indicating the start of the clinical trial process. Alternatively, the reader 12 on the implementation institution terminal 11 can read a two-dimensional code displayed on the user terminal 10, and the application on the implementation institution terminal 11 can decode the two-dimensional code and transmit the terminal-acquired data containing information to the clinical trial support system 1. Alternatively, the clinical trial support system 1 can transmit authentication data such as a one-time password to the user terminal 10, and the terminal-acquired data containing the authentication data can be transmitted to the clinical trial support system 1 via the user terminal 10.

[0045] The identification data may be input to the clinical trial support system 1, for example, by having the reader 12 read an identification card carried by the clinical trial participant. In this case, in addition to the data read by the reader 12, the identification data may further include a facial image of the clinical trial participant taken by a camera or a password entered by the clinical trial participant. If the personal information indicated by the input identification data matches the personal information recorded in the memory unit 9, it is determined that the identity of the participant has been authenticated. For example, identity authentication may be determined based on whether the personal information (such as name, date of birth, address, and identification number) previously recorded in association with the clinical trial participant ID matches the personal information in the input identification data. Alternatively, identity authentication may be determined by comparing the facial photograph on the ID with the facial image of the clinical trial participant taken by a camera and determining that they are the same person. Note that at least a part of the identity authentication process may be performed using an external authentication system (authentication server).

[0046] As another example, data indicating the results of staff at the clinical trial site checking the identification card brought by the clinical trial participant may be input as the identification card data. For example, the clinical trial support system 1 may display the personal information of the clinical trial participant identified by the terminal-acquired data on the clinical trial site terminal 11 and accept input by the staff to confirm that the personal information matches the personal information on the identification card. In this case, when the confirmation result indicating that the staff has checked the identity of the participant using the identification card is input as the identification card data, the participant is authenticated.

[0047] The clinical trial process start recording unit 3 records clinical trial process start data indicating the start of the clinical trial process, subject to the identification of the clinical trial participant using terminal-acquired data and personal authentication of the identified clinical trial participant using their identification data. This ensures that each clinical trial process is started by the actual clinical trial participant who applied to participate in the clinical trial. For example, it is possible to prevent participation in the clinical trial by impersonation or substitutes. It also ensures that the start of each clinical trial process for each clinical trial participant can be reliably recorded. This makes it easier to manage the clinical trial process.

[0048] The clinical trial process start data is data indicating that a clinical trial participant has started the clinical trial process. The clinical trial process start data is recorded in association with the clinical trial participant ID. The clinical trial process start data may include, for example, information indicating the clinical trial process and information indicating the start time of the clinical trial process.

[0049] In this way, the clinical trial process start recording unit 3 associates the clinical trial process start data indicating the start of each clinical trial process with the clinical trial participant ID. In other words, the clinical trial support system 1 recognizes that a clinical trial participant identified by the terminal-acquired data will begin a specific clinical trial process. For example, the terminal-acquired data may include information indicating the clinical trial process, and the clinical trial support system 1 may recognize the correspondence between the clinical trial participant and the clinical trial process based on this information. Alternatively, the correspondence between the clinical trial participant identified by the terminal-acquired data and the clinical trial process may be recognized from the acquisition time or location of the terminal-acquired data. As a specific example, when terminal-acquired data is acquired within a certain period including the scheduled start time of the clinical trial process, it is possible to recognize the correspondence between the clinical trial participant identified by the terminal-acquired data and the start of the clinical trial process. Alternatively, when terminal-acquired data is acquired via the reading device 12 or the implementation site terminal 11 located at a position corresponding to the start of the clinical trial process, it is possible to recognize the correspondence between the clinical trial participant identified by the terminal-acquired data and the start of the clinical trial process. In this way, the clinical trial process start recording unit 3 Based on the information contained in the terminal-acquired data, or the time or location of acquisition thereof, it is possible to recognize and associate the start of the clinical trial process with the clinical trial participants identified by the terminal-acquired data.

[0050] At the end of each clinical trial process, the clinical trial process completion recording unit 4 identifies the clinical trial participant using the terminal-acquired data acquired from the user terminal 10 of the clinical trial participant, and records the clinical trial process completion data indicating the end of the corresponding clinical trial process in the memory unit 9 in association with the clinical trial participant ID. Identification of the clinical trial participant using the terminal-acquired data can be performed in the same manner as the above-mentioned clinical trial process start recording unit 3. For example, the terminal-acquired data can be acquired from the user terminal 10 by reading a two-dimensional code or sending a one-time password to the user terminal 10, etc.

[0051] The clinical trial process completion data is data indicating that a clinical trial participant has completed the clinical trial process. The clinical trial process completion data is recorded in association with the clinical trial participant ID. The clinical trial process completion data may include, for example, information indicating the clinical trial process and information indicating the end time of the clinical trial process.

[0052] The clinical trial process completion recording unit 4 records the clinical trial process start data indicating the end of the clinical trial process, provided that the clinical trial participant is identified using the terminal-acquired data. This ensures that the completion of the clinical trial process for the clinical trial participant who was authenticated at the start of the clinical trial process is recorded, making clinical trial process management easier.

[0053] In this way, the clinical trial process completion recording unit 4 associates the clinical trial process completion data indicating the completion of each clinical trial process with the clinical trial participant ID. In other words, the clinical trial support system 1 recognizes that a clinical trial participant identified by the acquired terminal-acquired data has completed a specific clinical trial process. For example, if terminal-acquired data is acquired within a certain period including the scheduled completion time of the clinical trial process, it is possible to recognize the correspondence between the clinical trial participant identified by the terminal-acquired data and the completion of the clinical trial process. Alternatively, if terminal-acquired data is acquired via a reading device 12 or the implementation site terminal 11 located at a position corresponding to the completion of the clinical trial process, it is possible to recognize the correspondence between the clinical trial participant identified by the terminal-acquired data and the completion of the clinical trial process. In this way, the clinical trial process completion recording unit 4 can recognize and associate the completion of the clinical trial process with the clinical trial participant identified by the terminal-acquired data based on the information contained in the terminal-acquired data or the time or location of its acquisition.

[0054] The drug holiday period determination unit 5 acquires information identifying a clinical trial participant and determines the drug holiday period for the clinical trial participant identified by this information. This determination process is performed based on at least one of the clinical trial process start data and clinical trial process end data for the most recent past clinical trial in which the clinical trial participant participated. In other words, the drug holiday period for the clinical trial participant can be determined based on at least one of the clinical trial process start data and clinical trial process end data recorded in association with the clinical trial participant ID of the clinical trial participant identified by the acquired information. The information output as the determination result may be information indicating the drug holiday period for the clinical trial participant, or information indicating whether the implementation period of the clinical trial in which the clinical trial participant is participating or about to start overlaps with the drug holiday period.

[0055] For example, the drug holiday determination unit 5 determines the starting time (e.g., starting date) of the drug holiday period of the trial participant based on at least one of the start time and end time of at least one clinical trial process included in the clinical trial in which the trial participant most recently participated. A predetermined period starting from the starting time is determined to be the drug holiday period.

[0056] The method for determining the start time of the drug holiday and the length of the drug holiday period determined by the drug holiday period determination unit 5 may be fixed. Alternatively, the method for determining the start time of the drug holiday or the length of the drug holiday period may be determined based on clinical trial information for at least one clinical trial in which the clinical trial participant most recently participated or a clinical trial in which the clinical trial participant is about to participate or start. The clinical trial information may be, for example, the trial content (e.g., type of drug, dosing schedule during the trial, etc.) of the clinical trial in which the clinical trial participant most recently participated, or the trial content of the clinical trial in which the clinical trial participant is about to participate or start, and the calculation method for the start time of the drug holiday or the length of the drug holiday period may be determined based on the trial information.

[0057] For example, the clinical trial information stored in the memory unit 9 in association with the clinical trial ID may include information regarding the drug holiday period. The information regarding the drug holiday period may include, for example, information indicating how to determine the start time of the drug holiday period, or the length of the drug holiday period. As an example, depending on the clinical trial, a special drug holiday period from the most recently participated clinical trial may be specified. In such cases, the length of the drug holiday period specially specified in that clinical trial is recorded as the clinical trial information in the memory unit 9. The drug holiday period determination unit 5 can determine the drug holiday period of the clinical trial participant by further using the information regarding the drug holiday period in the clinical trial information associated with the clinical trial ID of the clinical trial in which the clinical trial participant most recently participated or the clinical trial to which the clinical trial participant is to participate.

[0058] The drug holiday period determination unit 5 can determine the drug holiday period of the clinical trial participant whose application for participation has been accepted by the application acceptance unit 2. In this case, the drug holiday period determination unit 5 acquires information identifying the clinical trial participant who has applied to participate, and determines the drug holiday period of the clinical trial participant based on at least one of the clinical trial process start data and clinical trial process end data of the most recent clinical trial recorded in association with the clinical trial participant's clinical trial participant ID. If it is determined that the implementation period of the clinical trial in which the clinical trial participant intends to participate overlaps with the drug holiday period, the application acceptance unit 2 or the drug holiday period determination unit 5 can output a notification to the user terminal 10 that the application for participation is rejected. This makes it possible to prevent a clinical trial participant who is in the drug holiday period from applying to participate in a new clinical trial. In other words, it is possible to prevent double entry during the drug holiday period.

[0059] The drug holiday period determination unit 5 can determine the drug holiday period of a clinical trial participant who is about to start the clinical trial process. In this case, the drug holiday period determination unit 5 acquires information about the clinical trial participant identified by the clinical trial process start recording unit 3 based on terminal-acquired data, and determines the drug holiday period of the clinical trial participant based on at least one of the clinical trial process start data and clinical trial process end data of the most recent clinical trial recorded in association with the clinical trial participant's clinical trial participant ID. If it is determined that the implementation period of the clinical trial that the clinical trial participant is about to start overlaps with the drug holiday period, the clinical trial process start recording unit 3 or the drug holiday period determination unit 5 can output a notification to the user terminal 10 that the participation application is rejected. This prevents a clinical trial participant who is in the drug holiday period from newly participating in the clinical trial.

[0060] The drug holiday information providing unit 81 accepts an inquiry request for an individual's drug holiday period and outputs information regarding the individual's drug holiday period. The inquiry request includes data identifying the individual being inquired. The data identifying the individual may include, for example, personal information corresponding to personal information recorded in the memory unit 9. This allows the individual's clinical trial participant ID to be identified by the data identifying the individual. The drug holiday information providing unit 81 determines the individual's drug holiday period based on at least one of the clinical trial process start data and clinical trial process end data for the most recent past clinical trial that is recorded in association with the clinical trial participant ID of the individual being inquired, and outputs the determination result. The determination result may include, for example, at least one of information indicating the individual's drug holiday period and information indicating whether the implementation period of the clinical trial in which the individual is participating or intends to start overlaps with the drug holiday period.

[0061] The drug holiday period information providing unit 81 can accept a request for an inquiry about a drug holiday period, for example, from a system external to the clinical trial support system 1. For example, it can accept input of personal information as a request for an inquiry about a drug holiday period from an external system. For example, a computer at a facility that is not compatible with the clinical trial support system 1 may be configured to be able to input at least a portion of the personal information that a clinical trial participant presents at the counter to the drug holiday period information providing unit 81 as a request for an inquiry about a drug holiday period.

[0062] The clinical trial participation information receiving unit 82 receives input of clinical trial participation information for clinical trials in which the clinical trial participant has previously participated, and records the clinical trial participation information in the memory unit 9 in association with the clinical trial participant ID of the clinical trial participant. The drug holiday period determination unit 5 or the drug holiday period information providing unit 81 can determine the drug holiday period of the clinical trial participant based on the clinical trial participation information stored in the memory unit 9. This makes it possible to acquire and record information indicating participation in clinical trials conducted outside the clinical trial support system 1. Therefore, information related to the drug holiday period can be recorded, and the drug holiday period can be checked more accurately.

[0063] The clinical trial participation information includes information indicating the clinical trial in which the participant participated and the time of participation in the clinical trial. For example, the clinical trial participation information may include information indicating at least one of the start and end times of each phase of the clinical trial. In this case, the clinical trial participation information may be recorded as clinical trial phase start data and / or clinical trial phase end data. The clinical trial participation information receiving unit 82 may also receive input of information for identifying the clinical trial participant (e.g., clinical trial participant ID or personal information) along with the clinical trial participation information.

[0064] The cooperation cost calculation unit 6 calculates the clinical trial cooperation costs for the clinical trial participant based on the clinical trial process start data and clinical trial process end data. If a clinical trial participant participates in all clinical trial processes in a single clinical trial, the clinical trial process start data and clinical trial process end data for each clinical trial process are recorded. If a clinical trial participant participates in only some of the multiple clinical trial processes in a single clinical trial and then withdraws and does not participate in the remaining clinical trial processes, the clinical trial process start data and clinical trial process end data for some of the clinical trial processes are recorded, but the clinical trial process start data and clinical trial process end data for the remaining clinical trial processes are not recorded. Therefore, after all clinical trial processes have been completed, the cooperation cost calculation unit 6 can determine the clinical trial processes in which the clinical trial participant participated, i.e., the participation record for each clinical trial process, based on the clinical trial process start data and clinical trial process end data associated with the clinical trial participant ID. For example, the clinical trial cooperation costs may be calculated based on the clinical trial participant's participation record in each clinical trial process. For example, the clinical trial cooperation fee may be calculated so that the clinical trial cooperation fee for participating in all clinical trial steps is lower than the fee for participating in only some of the clinical trial steps.

[0065] The memory unit 9 may pre-record, for example, actual cost correspondence data indicating the correspondence between the actual participation record in the clinical trial process determined based on the clinical trial process start data and clinical trial process end data and the clinical trial cooperation cost. The cooperation cost calculation unit 6 can calculate the clinical trial cooperation cost based on the clinical trial process start data and the clinical trial process end data using the actual cost correspondence data. The actual cost correspondence data may be recorded for each clinical trial, i.e., for each clinical trial ID. This makes it possible to set the clinical trial cooperation cost for each clinical trial according to the participation record.

[0066] The cooperation cost calculation unit 6 may calculate the clinical trial cooperation cost using data other than the clinical trial process start data and the clinical trial process end data. For example, the clinical trial cooperation cost may be calculated using data on the evaluation results of the clinical trial participant by the participant evaluation unit 7, which will be described later. Alternatively, special factors may be added to or subtracted from the clinical trial cooperation cost based on the clinical trial process start data and the clinical trial process end data. The special factors may be, for example, additional costs set to provide incentives to clinical trial participants. For example, incentives can be provided by adding cooperation costs to clinical trial participants whose evaluation results meet specified conditions or to those recruited suddenly with a short period until the application deadline, thereby encouraging them to participate in the clinical trial. Data indicating special factors may be recorded for each clinical trial.

[0067] The cooperation fee calculation unit 6 may calculate the clinical trial cooperation fee for each of multiple organizations that will bear the cooperation fee. For example, the clinical trial cooperation fee to be borne by at least two organizations selected from the clinical trial sponsoring organization, the clinical trial performing organization, the participant recruiting organization, and the clinical trial support system provider may be calculated. The clinical trial cooperation fee for one of the multiple organizations may be calculated based on clinical trial process start data and clinical trial process end data, and the clinical trial cooperation fee for the other organizations may be calculated based on pre-recorded cost data. In this way, for example, the clinical trial cooperation fee to be borne by one organization (e.g., the clinical trial sponsoring organization) may be calculated based on the participation record, and the clinical trial cooperation fee to be borne by the other organizations (e.g., the participant recruiting organization or the clinical trial support system provider) may be calculated based on the incentives for participation in the clinical trial or system use provided by the other organizations.

[0068] The clinical trial support system 1 may, for example, execute a payment process for the clinical trial cooperation fee. For example, the clinical trial support system 1 may output the clinical trial cooperation fee calculated by the cooperation fee calculation unit 6 to the user terminal 10, and execute a payment process for the clinical trial cooperation fee when the clinical trial participant inputs approval for the clinical trial cooperation fee to the user terminal 10. For example, a payment process using an electronic payment service using the user terminal 10, or an instruction to transfer the money to the account of the clinical trial participant may be executed.

[0069] The participant evaluation unit 7 calculates an evaluation value for a trial participant based on at least one of the clinical trial process start data and the clinical trial process end data. The evaluation value is stored in the storage unit 9 in association with the trial participant ID. The evaluation value for a trial participant calculated by the participant evaluation unit 7 may also be output to the user terminal 10 of the trial participant. For example, the evaluation value for a trial participant can be calculated based on at least one of the start and end times of at least one clinical trial process in the clinical trial. As an example, an evaluation value indicating whether or not a trial participant is late or the degree of lateness may be calculated based on the start time of the clinical trial process and the degree of delay relative to the scheduled time. Alternatively, the process time spent on the clinical trial process may be calculated based on the start and end times of the clinical trial process, and an evaluation value indicating the degree of promptness or delay of the trial participant may be calculated based on the process time. Furthermore, the participant evaluation unit 7 may calculate an evaluation value based on, for example, evaluation data input by the trial site in addition to at least one of the clinical trial process start data and the clinical trial process end data. This allows, for example, subjective evaluations by the trial site to be reflected in the evaluation value.

[0070] The cooperation cost calculation unit 6 may calculate the clinical trial cooperation cost based on the evaluation value calculated by the participant evaluation unit 7. For example, the cooperation cost calculation unit 6 may correct the clinical trial cooperation cost calculated based on the clinical trial process start data and the clinical trial process end data using the evaluation value.

[0071] The clinical trial support system 1 can notify the user terminal of the clinical trial participant of information related to the clinical trial for the clinical trial participant based on at least one of the clinical trial process start data and the clinical trial process end data of the clinical trial participant. The notified information related to the clinical trial may include, for example, guidance, instructions, or information related to the results of the clinical trial. For example, at the start and before the end of the clinical trial process, information related to the ongoing clinical trial process may be notified to the user terminal 10. Alternatively, if the clinical trial process start data or clinical trial process end data for that clinical trial process has not been recorded after a predetermined time has elapsed since the start or end time of the clinical trial process, a reminder may be notified to the user terminal 10. Alternatively, the start of the clinical trial process, i.e., the recording of the clinical trial process start data, may be triggered to notify the user terminal 10 of information about that clinical trial process. Alternatively, the end of the clinical trial process, i.e., the recording of the clinical trial process end data, may be triggered to notify the user terminal 10 of information about the next clinical trial process. Alternatively, after all clinical trial steps have been completed, the clinical trial cooperation costs calculated by the cooperation cost calculation unit 6 or the evaluation value calculated by the participant evaluation unit 7 may be notified to the user terminal 10.

[0072] The clinical trial support system 1 can be constructed using one or more computers. The functions of the application reception unit 2, clinical trial process start recording unit 3, clinical trial process end recording unit 4, drug holiday period determination unit 5, cooperation cost calculation unit 6, participant evaluation unit 7, drug holiday period information provision unit 81, and clinical trial participation information reception unit 82 can be realized by the computer's processor executing a predetermined program. Such programs, or non-transitory recording media on which programs are recorded, are also included in embodiments of the present invention. The memory unit 9 is constructed using a recording device accessible by the computers that make up the clinical trial support system.

[0073] The user terminal 10 comprises one or more computers. For example, an application for communicating data with the clinical trial support system 1 is installed on the user terminal 10. The application on the user terminal 10 may be, for example, a general-purpose application such as a browser, or a dedicated application for communicating with the clinical trial support system 1. The program of the dedicated application on the user terminal 10, i.e., the program that causes the computer of the user terminal 10 to execute processing, is also included in the embodiments of the present invention.

[0074] 2 is a functional block diagram showing an example configuration of the user terminal 10. The user terminal 10 has a clinical trial participation application unit 21, a clinical trial process initiation unit 22, and a clinical trial process termination unit 23. These functional units are realized, for example, by the computer of the user terminal 10 executing processes in accordance with the program of an application to be installed. As an example, the system is configured so that a clinical trial participant can use each function of the application by logging in by entering their own account information, for example, a user ID and password.

[0075] The clinical trial participation application unit 21 supplies participation application data to the clinical trial support system 1 based on input from the clinical trial participant. For example, when a clinical trial participant inputs information about a clinical trial in which they wish to participate, the clinical trial participation application unit 21 transmits participation application data including information indicating the clinical trial in which they wish to participate and the clinical trial participant to the clinical trial support system 1. The clinical trial participation application unit 21 may supply, as participation application data, for example, responses to an initial questionnaire about the clinical trial in which they wish to participate, input by the clinical trial participant, to the clinical trial support system 1. In this case, the user terminal 10 may receive from the clinical trial support system 1 the result of whether or not to allow the participant to participate in the clinical trial (approved or rejected) based on the responses to the initial questionnaire, and display it.

[0076] When the clinical trial process initiation unit 22 detects the start of the clinical trial process of a clinical trial based on input from a clinical trial participant or information acquired from the clinical trial support system, it supplies terminal-acquired data for identifying the clinical trial participant to the clinical trial support system 1. For example, the start of the clinical trial process is detected when a clinical trial participant performs an input operation on the user terminal 10 to instruct the start of the clinical trial process. Alternatively, the start of the clinical trial process may be detected by the user terminal 10 reading a two-dimensional code issued by the clinical trial support system 1 or receiving data from the clinical trial support system 1 via a network to acquire information regarding the start of the clinical trial process.

[0077] When the clinical trial process completion unit 23 detects the end of the clinical trial process of a clinical trial based on input from the clinical trial participant or information acquired from the clinical trial support system, it supplies terminal-acquired data for identifying the clinical trial participant to the clinical trial support system 1. For example, the end of the clinical trial process is detected when the clinical trial participant performs an input operation on the user terminal 10 to instruct the end of the clinical trial process. Alternatively, the end of the clinical trial process may be detected by the user terminal 10 reading a two-dimensional code issued by the clinical trial support system 1 or receiving data from the clinical trial support system 1 via a network to acquire information regarding the end of the clinical trial process.

[0078] The terminal-acquired data supplied to the clinical trial support system 1 at the start or end of the clinical trial process may include, for example, information identifying the clinical trial participant. For example, the terminal-acquired data may include the trial participant's account information, personal information, or information identifying the user terminal. Alternatively, the terminal-acquired data may include authentication data such as a one-time password acquired from the clinical trial support system 1 at the start of the clinical trial process. The terminal-acquired data may also include information indicating the start of the clinical trial process or information indicating the end of the clinical trial process.

[0079] (Example of clinical trial support system operation) Figure 3 is a sequence diagram showing an example of the operation of the clinical trial support system 1 shown in Figure 1. In the example of Figure 3, the operation of the clinical trial support system 1 includes the phases of participation application, clinical trial process, and cooperation fee payment, and the clinical trial process includes a screening test process, a main test process, and a post-main test test process.

[0080] [Participation application] In the participation application phase, the application reception unit 2 of the clinical trial support system 1 receives an input of an application to participate in a clinical trial from the user terminal 10 (S1). The application reception unit 2 obtains information indicating the clinical trial in which the user wishes to participate and the clinical trial participant from the user terminal 10. The clinical trial ID of the clinical trial in which the user wishes to participate is recorded in association with the clinical trial participant ID (S2). Note that in the participation application, a process may be executed in which the responses to the initial questionnaire entered from the user terminal 10 are made viewable by the clinical trial site or the clinical trial sponsoring institution and an input of approval / denial of participation is accepted. In this case, the result of approval / denial of participation is notified to the user terminal 10. If approval is granted, the clinical trial ID of the clinical trial in which the clinical trial participant has been approved to participate is recorded in association with the clinical trial participant ID as a clinical trial in which the clinical trial participant can participate.

[0081] Before or after the application for participation, the clinical trial support system 1 accepts input of personal information of the trial participant from the user terminal 10 (S3), and stores the information in the memory unit 9 in association with the trial participant ID (S4). The personal information includes, for example, at least one of name, date of birth, address, and various identification numbers. The personal information may also include terminal identification information such as a telephone number that identifies the user terminal 10. The personal information may also be input by reading the trial participant's identification card with the user terminal 10. Alternatively, the personal information may also be input into the clinical trial support system 1 by reading the identification card brought by the trial participant with the reader 12 of the implementation site terminal 11.

[0082] [Screening inspection process] In the screening test process, the trial participant visits the implementation institution and undergoes the test. The trial participant checks in using the user terminal 10 at the start location of the clinical trial process (screening test process) at the implementation institution. As a check-in operation, the trial participant, for example, causes the user terminal 10 to read a two-dimensional code (e.g., a QR code (registered trademark)) issued by the clinical trial support system 1. The two-dimensional code is displayed, for example, on the implementation institution terminal 11 at the start location of the clinical trial process. The two-dimensional code may include information indicating the start of the clinical trial process (screening test process) and authentication information such as a one-time password. The user terminal 10 transmits the authentication information obtained by decoding the two-dimensional code and terminal-acquired data including information identifying the trial participant to the clinical trial support system 1 via the network (S5). The clinical trial process start recording unit 3 of the clinical trial support system 1 uses the terminal-acquired data to perform authentication processing for the trial participant, thereby identifying the trial participant (S6).

[0083] Once the clinical trial participant is identified, the clinical trial support system 1 displays the personal information recorded in association with the identified clinical trial participant's clinical trial participant ID on the implementation institution terminal 11 located at the start position of the clinical trial process (screening test process) (S7). The implementation institution staff at the start position of the clinical trial process (screening test process) check whether the personal information written on the identification card brought by the clinical trial participant matches the personal information displayed on the implementation institution terminal 11. The staff also check whether the facial photograph on the identification card matches the face of the clinical trial participant. The staff inputs into the implementation institution terminal 11 a message indicating that the personal information matches and that the face and facial photograph match. This input constitutes the input of identification card data (S8), and the clinical trial process start recording unit 3 performs identity authentication based on the identification card data (S9). Once the clinical trial participant has been identified in S6 and the identity authentication in S9 has been performed, the clinical trial process start data is recorded in association with the clinical trial participant ID (S10). This process records personal information confirmed by a third party other than the trial participant (in this example, a staff member) in the memory unit 9, ensuring that the trial participant undergoing the trial process is a person whose personal information matches. Note that if the personal information on the ID card differs from the displayed personal information (for example, if the recorded personal information is incomplete, incorrect, or outdated), the staff member can update the personal information in the memory unit 9 via the implementing institution terminal 11.

[0084] At the end of the screening test process, the trial participant performs a checkout operation using the user terminal 10. As a checkout operation, the trial participant, for example, causes the user terminal 10 to read a two-dimensional code issued by the clinical trial support system 1. The two-dimensional code is displayed, for example, on the implementation institution terminal 11 at the location where the clinical trial process ends. The two-dimensional code may include information indicating the end of the clinical trial process (screening test process) and authentication information such as a one-time password. The user terminal 10 transmits the authentication information obtained by decoding the two-dimensional code and terminal-acquired data including information identifying the trial participant to the clinical trial support system 1 via the network (S11). The clinical trial process completion recording unit 4 of the clinical trial support system 1 identifies the trial participant by performing authentication processing of the trial participant using the terminal-acquired data (S12). The clinical trial process completion data is recorded in the memory unit 9 in association with the trial participant ID of the identified trial participant (S13).

[0085] By the processing of S5 to S13, data indicating the start and end of the clinical trial process (screening test process) is recorded in the storage unit 9. As a result, information such as the start and end of the clinical trial process, or whether it was terminated midway, is managed by the clinical trial support system 1. Although not shown in FIG. 3, the clinical trial support system 1 may accept input of the results of the clinical trial process (e.g., pass / fail of the screening test) via the implementation institution terminal 11. After the clinical trial process is completed, the clinical trial support system 1 may notify the user terminal 10 of the results of the clinical trial process (screening test results). For example, if the result of the screening test is fail, the subsequent clinical trial processes (main test process and test processes after the main test) will not be conducted for that clinical trial participant. This information is notified to the user terminal 10. In addition, the fact that the participant will not participate in the subsequent clinical trial processes may be recorded in association with the clinical trial participant ID.

[0086] [Main test process] In this test process, the trial participant visits the implementation institution and undergoes testing. At the start of this test process, the acquisition of terminal-acquired data associated with the check-in operation, identification of the trial participant using the terminal-acquired data, input acceptance of identification data, personal authentication based on the identification data, and recording of clinical trial process start data are performed in the same manner as in S5 to S10 above. At the end of this test process, the acquisition of terminal-acquired data associated with the check-out operation, identification of the trial participant using the terminal-acquired data, and recording of clinical trial process end data are performed in the same manner as in S11 to S13 above.

[0087] [Inspection process after the main test] In the post-main test inspection process, the trial participant visits the implementation institution and undergoes the inspection. At the start of the post-main test inspection process, the acquisition of terminal-acquired data associated with the check-in operation, identification of the trial participant using the terminal-acquired data, personal authentication based on identification data, and recording of the trial process start data are performed in the same manner as in S5 to S10 above. At the end of the post-main test inspection process, the acquisition of terminal-acquired data associated with the check-out operation, identification of the trial participant using the terminal-acquired data, and recording of the trial process end data are performed in the same manner as in S11 to S13 above. With the end of the main test trial process, the clinical trial is completed, and the completion of the trial is recorded in association with the trial participant ID. Note that depending on the type of clinical trial, there may not be a post-main test inspection process. In that case, the clinical trial is completed with the end of the main test trial process.

[0088] [Payment of clinical trial cooperation fees] After the completion of all clinical trial steps, the cooperation cost calculation unit 6 calculates the clinical trial cooperation cost based on the clinical trial process start data and clinical trial end data for the screening test process, the main test process, and the post-main test test process (S14). For example, the cooperation cost calculation unit 6 determines the actual amount of participation by the clinical trial participant out of the planned amount of participation in the clinical trial based on the clinical trial process start data and clinical trial end data of the clinical trial participant, and calculates the clinical trial cooperation cost based on this actual amount. For example, the number of clinical trial steps that the clinical trial participant actually participated in out of the total planned number of clinical trial steps is determined based on the clinical trial process start data and clinical trial process end data. Alternatively, the percentage of the planned clinical trial commitment (such as hospitalization period or number of visits) that the clinical trial participant was able to complete may be determined based on the clinical trial process start data and clinical trial process end data. For example, if a clinical trial participant withdraws after completing 50% of the planned commitment, the clinical trial cooperation cost is calculated as 50% of the full amount. The cooperation cost calculation unit 6 may, for example, accept input of adjustments to the calculated clinical trial cooperation costs from the implementation site terminal 11.

[0089] Furthermore, in the clinical trial cost calculation in S14, in addition to the clinical trial cooperation cost based on the actual participation volume, an additional clinical trial cooperation cost as an incentive may also be calculated. The additional clinical trial cooperation cost may be calculated, for example, based on the evaluation value calculated by the participant evaluation unit 7. Alternatively, an additional clinical trial cooperation cost preset for each clinical trial may be calculated. The sum of the clinical trial cooperation cost based on the actual participation volume and the additional clinical trial cooperation cost may be calculated as the final clinical trial cooperation cost. By calculating the additional clinical trial cooperation cost in this way, for example, a person or organization other than the clinical trial sponsoring organization that bears the clinical trial cooperation cost based on the actual participation volume, such as a participant recruitment organization, a clinical trial support system provider, or a clinical trial institution, can independently provide incentives to clinical trial participants.

[0090] The clinical trial support system 1 displays the clinical trial cooperation fee calculated by the cooperation fee calculation unit 6 on the user terminal 10 (S15), and receives approval for the clinical trial cooperation fee from the clinical trial participant (S16). Once approval is received, the clinical trial support system 1 executes payment processing (S17). The payment processing is executed, for example, by notifying the settlement system 13 of information indicating the bank account to which the clinical trial participant should transfer the fee, acquired from the user terminal 10, and the clinical trial cooperation fee, and requesting the transfer.

[0091] The above process ensures that the application for clinical trial participation, the screening test process, the main test process, the post-main test test process, and the payment of clinical trial cooperation fees are all made to the same clinical trial participant. In particular, identity authentication is performed at the start of each clinical trial process, including the screening test process, the main test process, and the post-main test test process, preventing substitutes and mix-ups of clinical trial participants. Because personal information for identity authentication is managed by the clinical trial support system 1, there is little or no personal information to manage at each of the multiple institutions involved in the clinical trial, such as the clinical trial sponsoring institution, the clinical trial institution, and the participant recruitment institution. Furthermore, throughout the entire clinical trial flow, clinical trial participants can use the user terminal 10 to complete procedures with the clinical trial support system 1, thereby improving the work efficiency of clinical trial participants.

[0092] [Data example] FIG. 4 shows examples of clinical trial process start data and clinical trial process end data. In the example of FIG. 4, the clinical trial ID, process number, start or end, and start or end time are recorded in association with the clinical trial participant ID. In this way, information indicating the start and end of the clinical trial process, as well as the start and end times, is recorded for each clinical trial process in which each clinical trial participant participated. This makes it easy to manage the participation status of each clinical trial participant in clinical trials in which they have participated in the past or present. By using the clinical trial process start data and clinical trial process end data, it is possible to efficiently determine, for example, the drug holiday period for a clinical trial participant, evaluate the clinical trial participant, or notify the clinical trial participant according to the progress of the clinical trial process.

[0093] [Example of determining the drug holiday period] In the operational example shown in FIG. 3 , when an input of an application to participate in a clinical trial is accepted from the user terminal 10 in S1, the drug holiday period determination unit 5 may determine whether the drug holiday period overlaps with the implementation period of the clinical trial in which the clinical trial participant is to participate. If it is determined that the drug holiday period overlaps with the implementation period of the clinical trial, the application acceptance unit 2 displays a message to that effect on the user terminal 10 and does not record the participation application information in the storage unit 9. This makes it possible to prevent double entry during the drug holiday period. Furthermore, if a clinical trial participant is identified by terminal-acquired data at the start of at least one of the screening test process, the main test process, and the post-main test test process, the drug holiday period determination unit 5 may determine whether the drug holiday period overlaps with the implementation period of the clinical trial in which the clinical trial participant is to start. If it is determined that the drug holiday period overlaps with the implementation period of the clinical trial, the application acceptance unit 2 displays a message to that effect on the user terminal 10 and does not record the clinical trial process start data. This makes it possible to prevent the start of the clinical trial process during the drug holiday period.

[0094] The drug holiday period determination unit 5 determines the start time of the drug holiday period using the clinical trial process start data and / or clinical trial process end data of the most recent past clinical trial, among the clinical trial process start data and clinical trial process end data associated with the clinical trial participant ID. For example, the start time of the drug holiday period can be either the start time indicated by the clinical trial process start data or the end time indicated by the clinical trial process end data of the most recent past clinical trial, including medication (e.g., the main test process). Alternatively, the start time of the drug holiday period may be a predetermined time point or day between the start and end of the clinical trial process including medication. How to determine the start time using the clinical trial process start data and / or clinical trial process end data of the most recent past clinical trial may be determined, for example, based on the clinical trial information. The drug holiday period determination unit 5 determines a predetermined length of time from the start time of the drug holiday period as the drug holiday period. This predetermined length of time may be determined based on trial information for at least one of the previous trials in which the trial participant most recently participated and the trial in which the trial participant is about to participate or begin.

[0095] [Example of evaluation of clinical trial participants] In the operational example of Figure 3, the participant evaluation unit 7 may calculate the evaluation value of the trial participant, for example, when the clinical trial process completion data for each clinical trial process, i.e., the screening test process, the main test process, and the post-main test test process, is recorded. Alternatively, the evaluation value of the clinical trial evaluator may be calculated after the end of the period for all clinical trial processes of the clinical trial and before the calculation of the clinical trial cooperation fee (S14). The participant evaluation unit 7 can calculate the evaluation value of the trial participant, for example, based on the degree of delay from the scheduled disclosure at the start indicated by the clinical trial process start data for each clinical trial process recorded in association with the clinical trial participant ID.

[0096] [Other variations] In the example shown in Figure 3, clinical trial process start data is recorded for all clinical trial processes included in the clinical trial, subject to participant identification using terminal-acquired data and personal authentication using identification data. As a variation, for some of the clinical trial processes included in the clinical trial, personal authentication using identification data may be omitted, and participant identification using terminal-acquired data may be performed, and the clinical trial process start data may be recorded. For example, if a clinical trial process for which personal identification is not important is included, personal authentication using identification data for that clinical trial process may be omitted, and work efficiency may be prioritized.

[0097] (Example of user terminal operation) FIG. 5 is a flowchart showing an example of application processing in the user terminal 10. In the example of FIG. 5, when the application is launched, for example, a menu screen is displayed and instructions from the user are accepted. The application becomes available when the user is logged in with the trial participant's account. In the example of FIG. 5, the user can instruct any of the following: inputting a participation application, starting the clinical trial process, ending the clinical trial process, displaying a notification, and closing the application. Here, the user may be able to instruct the start and end of the clinical trial process when predetermined conditions are met. For example, the start and end of the clinical trial process may be selectable within the scheduled start or end period of the clinical trial process, or when information indicating the start or end of the clinical trial process is obtained from the clinical trial support system 1. Alternatively, the start or end of the clinical trial process may be instructed to the user terminal 10 from the clinical trial support system 1 based on input from the clinical trial site.

[0098] When the user instructs to input an application for participation (YES in S20), the user terminal 10 displays a participation application screen and accepts the input of the application for participation (S21). The participation application screen may, for example, accept the input of search conditions for the clinical trial. For example, the period of the clinical trial, the contents of the clinical trial, the clinical trial cooperation fee, etc. may be specified as search conditions. The user terminal 10 transmits the input search conditions to the clinical trial support system 1 and receives the search results. As the search results, a list of clinical trials that match the search conditions is displayed in a selectable manner. The user can input an application to participate in that clinical trial by selecting a clinical trial.

[0099] When the user inputs an instruction to start the clinical trial process, the user terminal 10 detects the start of the clinical trial process (YES in S22) and executes the clinical trial process start processing (S23). In S23, the user terminal 10 provides terminal-acquired data to the clinical trial support system 1. The terminal-acquired data includes information for identifying the clinical trial participants. The terminal-acquired data may also include information indicating the start of the clinical trial process. In S23, for example, the user terminal 10 outputs a message instructing the user to read a two-dimensional code issued by the clinical trial support system 1 and activates the camera for reading. In this case, the user terminal 10 transmits terminal-acquired data including authentication information obtained by decoding the read two-dimensional code to the clinical trial support system 1. Alternatively, the user terminal 10 may display the two-dimensional code on the screen and output a message instructing the implementation institution terminal 11 to read the two-dimensional code. In this case, the two-dimensional code includes information from the terminal-acquired data. In addition, the start of the clinical trial process in S22 may be detected not by input of an instruction from the user, but by an instruction to start the clinical trial process supplied from the clinical trial support system 1 to the user terminal 10 based on input from the implementing institution, for example.

[0100] When the user inputs an instruction to end the clinical trial process, the user terminal 10 detects the end of the clinical trial process (YES in S24) and executes clinical trial process end processing (S25). In S25, the user terminal 10 supplies terminal-acquired data to the clinical trial support system 1. The terminal-acquired data includes information for identifying the clinical trial participants. The terminal-acquired data may also include information indicating the end of the clinical trial process. The supply of terminal-acquired data in S25 can be executed, for example, in the same manner as in S23. Note that the detection of the end of the clinical trial process in S24 may be detected not by input of an instruction from the user, but by an instruction to end the clinical trial process supplied from the clinical trial support system 1 to the user terminal 10 based on input from the implementing institution, for example.

[0101] If there is an unread notification from the clinical trial support system 1 to the user terminal 10, when the application is launched, a message indicating that there is an unread notification is displayed. In this case, the user can instruct the user terminal 10 to display the notification. When the user instructs the user to display the notification (YES in S26), the content of the notification is displayed on the screen of the user terminal 10 (S27). When the user performs an operation to instruct the user to terminate the application (YES in S28), the application is terminated.

[0102] Although the embodiments of the present invention have been described above, the above-described embodiments are merely examples for carrying out the present invention. Therefore, the present invention is not limited to the above-described embodiments, and can be carried out by appropriately modifying the above-described embodiments within the scope of the spirit of the present invention. [Explanation of symbols]

[0103] 1: Clinical trial support system, 2: Application reception unit, 3: Clinical trial process start recording unit, 4: Clinical trial process end recording unit, 5: Drug holiday period determination unit, 6: Cooperation cost calculation unit, 7: Participant evaluation unit, 81: Drug holiday period information provision unit, 82: Clinical trial participation information reception unit, 9: Memory unit

Claims

1. an application input receiving unit that receives an application to participate in a clinical trial via a user terminal of the clinical trial participant and records the clinical trial participant ID of the clinical trial participant in a storage unit in association with a clinical trial ID that identifies the clinical trial; a clinical trial process start recording unit that, at the start of each of a plurality of clinical trial processes in a clinical trial identified by the clinical trial ID, identifies the clinical trial participant ID using terminal-acquired data acquired from the user terminal of the clinical trial participant, accepts input of identification data including personal information based on the identification card brought by the clinical trial participant, and, if the participant is authenticated based on the identification data, records clinical trial process start data indicating the start of the corresponding clinical trial process in the memory unit in association with the clinical trial participant ID; a clinical trial process completion recording unit that, at the end of each of the multiple clinical trial processes in the clinical trial identified by the clinical trial ID, identifies the clinical trial participant ID using terminal-acquired data acquired from the user terminal of the clinical trial participant at the end of the process in which the clinical trial participant ID is identified and the identity authentication is performed and the clinical trial process start data is recorded, and records clinical trial process completion data indicating the completion of the corresponding clinical trial process in the memory unit in association with the clinical trial participant ID; A clinical trial support system equipped with:

2. The clinical trial support system according to claim 1, A clinical trial support system further comprising a drug holiday determination unit that acquires information identifying a clinical trial participant, and determines a drug holiday period during which the clinical trial participant cannot participate in the clinical trial based on at least one of the clinical trial process start data and the clinical trial process end data of the most recent past clinical trial in which the clinical trial participant identified by the information participated.

3. The clinical trial support system according to claim 1 or 2, The clinical trial support system further comprises a cooperation cost calculation unit that calculates the clinical trial cooperation costs for the clinical trial participants based on the clinical trial process start data and the clinical trial process end data.

4. A computer-implemented clinical trial support method, comprising: an application input receiving step of receiving an application to participate in a clinical trial via a user terminal of the clinical trial participant, and recording the clinical trial participant ID of the clinical trial participant in a storage unit in association with a clinical trial ID that identifies the clinical trial; a clinical trial process start recording step, which, at the start of each of a plurality of clinical trial processes in the clinical trial identified by the clinical trial ID, identifies the clinical trial participant ID using terminal-acquired data acquired from the user terminal of the clinical trial participant, accepts input of identification data including personal information based on the identification card brought by the clinical trial participant, and, if the participant is authenticated based on the identification data, records clinical trial process start data indicating the start of the corresponding clinical trial process in the memory unit in association with the clinical trial participant ID; a clinical trial process completion recording step for identifying the clinical trial participant ID using terminal-acquired data acquired from the user terminal of the clinical trial participant at the end of each of the multiple clinical trial processes in the clinical trial identified by the clinical trial ID, and recording clinical trial process completion data indicating the completion of the corresponding clinical trial process in the memory unit in association with the clinical trial participant ID; A clinical trial support method comprising:

5. an application input acceptance process for accepting an application to participate in a clinical trial via the user terminal of the clinical trial participant, and recording the clinical trial participant ID of the clinical trial participant in a storage unit in association with a clinical trial ID that identifies the clinical trial; a clinical trial process start recording process that, at the start of each of a plurality of clinical trial processes in the clinical trial identified by the clinical trial ID, identifies the clinical trial participant ID using terminal-acquired data acquired from the user terminal of the clinical trial participant, accepts input of identification data including personal information based on the identification card brought by the clinical trial participant, and, if the participant is authenticated based on the identification data, records clinical trial process start data indicating the start of the corresponding clinical trial process in the memory unit in association with the clinical trial participant ID; a clinical trial process completion recording process for identifying the clinical trial participant ID using terminal-acquired data acquired from the user terminal of the clinical trial participant at the end of each of a plurality of clinical trial processes in the clinical trial identified by the clinical trial ID, and recording clinical trial process completion data indicating the completion of the corresponding clinical trial process in the storage unit in association with the clinical trial participant ID; A clinical trial support program that runs the following on a computer.

6. A user terminal capable of data communication with the clinical trial support system according to claim 1 or 2, a clinical trial participation application unit that supplies participation application data including the clinical trial in which the clinical trial participant wishes to participate and the clinical trial participant based on input from the clinical trial participant to the clinical trial support system; a clinical trial process initiation unit that, when detecting the start of the clinical trial process of the clinical trial based on input from the clinical trial participant or information acquired from the clinical trial support system, supplies terminal-acquired data for identifying the clinical trial participant to the clinical trial support system; A user terminal comprising: a clinical trial process completion unit that, when the end of the clinical trial process of the clinical trial is detected based on input from the clinical trial participant or information obtained from the clinical trial support system, supplies the clinical trial support system with terminal-acquired data for identifying the clinical trial participant.

7. A program that causes a user terminal capable of data communication with the clinical trial support system according to claim 1 or 2 to execute processing, a clinical trial participation application process that provides the clinical trial support system with participation application data including the clinical trial in which the clinical trial participant wishes to participate and the clinical trial participant based on input from the clinical trial participant; a clinical trial process initiation process that, when the start of the clinical trial process of the clinical trial is detected based on input from the clinical trial participant or information acquired from the clinical trial support system, supplies terminal-acquired data for identifying the clinical trial participant to the clinical trial support system; A program that causes the user terminal to execute a clinical trial process completion unit that supplies terminal-acquired data to the clinical trial support system to identify the clinical trial participant when the end of the clinical trial process of the clinical trial is detected based on input from the clinical trial participant or information obtained from the clinical trial support system.

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