Examinee candidate extraction system, examinee candidate extraction device, examinee candidate extraction method and program

Abstract

To provide an examinee candidate extraction system for promptly and efficiently extracting an examinee candidate of a clinical research by utilizing information collected on the basis of the will of a patient, an examinee candidate extraction device, an examinee candidate extraction method and a program.SOLUTION: An examinee candidate extraction system 1 includes an integrated repository 11 and an examinee candidate extraction device 17. The integrated repository 11 stores in an associated manner, medical information of a patient which is inputted or generated by a medical institution and previously permitted by the patient, the physical information of the patient inputted or generated by the patient and previously permitted by the patient, and information relating to the will of the patient to be an examinee candidate. The examinee candidate extraction device 17 extracts from the integrated repository 11 the patient having the predetermined medical information and the physical information from among the patients having the wills to be the examinee candidate in accordance with a selection condition or algorithm.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a subject candidate extraction system, a subject candidate extraction device, a subject candidate extraction method, and a program, and relates to a technique for quickly and efficiently extracting subject candidates for clinical research by using medical information and physical information collected based on the patient's wishes, for example. [Background technology]

[0002] Traditionally, the general method for recruiting subjects for clinical research (including clinical trials) was for personnel at pharmaceutical companies and other research institutions to inquire about the availability of subject candidates to doctors at major medical institutions. Because this method relies on the memory of the doctor, there were cases where suitable subject candidates were overlooked due to the doctor's forgetfulness, etc. In addition, inquiring each medical institution required a large amount of cost.

[0003] In recent years, personal health record (PHR) services that allow patients to manage and access their own medical information (treatment records from medical institutions, etc.) and physical information (e.g. vital signs and ePRO: electronic patient reported outcome, etc.) via an app have started to become popular. In addition, a government-led service has been launched that consolidates the medical information of citizens and allows patients to access their own medical information via My Number Portal. Furthermore, My Number Portal API has been released as an interface for applications provided by private PHR businesses to use the consolidated medical information with the patient's consent.

[0004] Against this background, several technologies have been proposed to extract potential subjects by utilizing databases that store medical and physical information about patients.

[0005] Patent Document 1 describes the selection of subject candidates based on information on prescriptions and dispensing prescribed to patients. It also suggests that clinical trials will be conducted using patient-derived information (medication information, etc.) generated by the patients who become subjects.

[0006] Patent document 2 describes that subjects are selected based on a diary (including blood pressure, body temperature, number of steps, weight, visceral fat level, BMI, calorie activity, electrocardiogram, blood glucose level, body fat, cholesterol level, triglyceride, GOT, GPT, uric acid level, Hba1c, etc.) sent periodically from the potential subject's terminal device. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] JP 2016-024663 A [Patent Document 2] JP 2011-233066 A Summary of the Invention [Problem to be solved by the invention]

[0008] However, these conventional techniques cannot build a framework in which information about a patient is collected based on the patient's own will and the patient decides whether or not to provide the information for screening of potential subjects based on the patient's own will.Furthermore, they cannot extract potential subjects by combining not only medical information, which is information from medical institutions, but also physical information, which is information from patients.

[0009] In the system described in Patent Document 1, information on patients' prescriptions and dispensing is collected in a database by pharmacists, etc., and is not under the control of the patient. In addition, although patient-derived information is information that the patient can control, it is not clear how this information will be used when selecting potential subjects, and it is merely suggested that this information can be used during clinical trials.

[0010] The system described in Patent Document 2 is designed to collect information from patients who have already expressed a desire to participate in clinical trials, and does not disclose the idea of ​​extracting potential subjects based on information collected in accordance with the patient's wishes.

[0011] The present invention has been made to solve these problems, and aims to provide a subject candidate extraction system, subject candidate extraction device, subject candidate extraction method, and program that utilize medical information and physical information collected based on the patient's wishes to quickly and efficiently extract subject candidates for clinical research. [Means for solving the problem]

[0012] In one embodiment, the subject candidate extraction system is a subject candidate extraction system including an integrated repository and a subject candidate extraction device, wherein the integrated repository stores medical information of the patient, which is input or generated by a medical institution and with the patient's prior consent, physical information of the patient, which is input or generated by the patient and with the patient's prior consent, and information regarding the patient's willingness to become a subject candidate, in association with each other, and the subject candidate extraction device extracts, from the integrated repository, patients who have predetermined medical information and physical information from among the patients who are willing to become subject candidates in accordance with selection conditions or an algorithm. In one embodiment, the federated repository obtains the medical information from a healthcare institution system or a medical information repository that aggregates the medical information created or generated by one or more healthcare institutions. In one embodiment, the physical information includes life log information, health condition information, or medical interview information acquired by a physical information management device. In one embodiment, the integrated repository accepts designation by the patient of the types of medical and physical information for which consent is to be granted. In one embodiment, the integrated repository accepts designation by a patient of the types of medical information and physical information to be subject to approval, collects the medical information that is subject to approval from the patient's medical information input or generated by a medical institution, collects the physical information that is subject to approval from the patient's physical information input or generated by the patient, collects information regarding the patient's willingness to become a subject candidate, and links and stores the collected medical information, physical information, and information regarding the willingness to become a subject candidate. In one embodiment, the subject candidate extraction device refers to the repository in accordance with selection conditions or an algorithm, and extracts patients who have the specified medical information and physical information from among the patients who are willing to become subject candidates. In one embodiment, the subject candidate extraction method includes the steps of: receiving, in an integrated repository, a designation by a patient of the types of medical information and physical information to be subject to consent; collecting medical information of the patient that is input or generated by a medical institution and has been previously consented to by the patient; collecting physical information of the patient that is input or generated by the patient and has been previously consented to by the patient; collecting information regarding the patient's willingness to become a subject candidate; linking and storing the collected medical information, physical information, and information regarding the willingness to become a subject candidate; and extracting, in the subject candidate extraction device, patients who have predetermined medical information and physical information from among the patients who are willing to become subject candidates in accordance with selection conditions or an algorithm. In one embodiment, a method for creating an integrated repository includes the steps of accepting, from a patient, a designation of the types of medical information and physical information to be subject to consent; collecting the patient's medical information input or generated by a medical institution and with prior consent from the patient; collecting the patient's physical information input or generated by the patient and with prior consent from the patient; collecting information regarding the patient's willingness to be a subject candidate; and linking and storing the collected medical information, physical information, and information regarding the willingness to be a subject candidate. In one embodiment, the subject candidate extraction method includes a step of extracting patients who are willing to become subject candidates and who have certain of the medical information and physical information in accordance with selection criteria or an algorithm. In one embodiment, a program causes a computer to carry out the above method. Effect of the Invention

[0013] The present invention provides a subject candidate extraction system, subject candidate extraction device, subject candidate extraction method, and program that utilize medical information and physical information collected based on the patient's wishes to quickly and efficiently extract subject candidates for clinical research. [Brief description of the drawings]

[0014] [Figure 1] FIG. 1 is a block diagram showing a configuration of a subject candidate extraction system 1. [Diagram 2] 3 is a flowchart showing the operation of the subject candidate extraction system 1. [Diagram 3] 13 is an example of a confirmation screen for confirming an intention regarding acquisition of various information. [Figure 4] 13 is an example of a confirmation screen for confirming the intention to become a subject candidate. [Diagram 5] FIG. 1 is a block diagram showing a configuration of a subject candidate extraction system 1. [Figure 6] 3 is a flowchart showing the operation of the subject candidate extraction system 1. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] <Embodiment 1> 1 is a block diagram showing a configuration of a subject candidate extraction system 1 according to a first embodiment of the present invention. The subject candidate extraction system 1 includes an integrated repository 11, a physical information management device 15, and a subject candidate extraction device 17.

[0016] The integrated repository 11 is a computer system for aggregating medical information, physical information, information on willingness to become a subject candidate, and the like, of one or more patients. The integrated repository 11 is typically a server computer, a cloud computing environment, or the like that can be accessed by each patient using his or her own terminal device (personal computer (PC), smartphone, etc.). These information processing environments may be provided by third parties (such as PHR service providers). Even in this case, patients can manage the input and output of the above-mentioned information under their own control using the control function described below. Alternatively, some or all of the functions of the integrated repository 11 may be implemented in the patient's terminal device. In this case, the integrated repository 11 may be configured as a so-called distributed database.

[0017] The integrated repository 11 stores, in a storage area, medical information, physical information, information on willingness to become a subject candidate, and the like, of one or more patients. In addition, when acquiring or outputting this information, it performs control so as to reflect the will of the patient himself / herself.

[0018] (Medical Information) Medical information is information input or generated in the medical institution system 21, which is a computer system used by a medical institution. For example, medical information includes patient medical information, examination information, prescription information, dispensing information, specific medical checkup information, medical fee notification information, and the like generated in a medical institution (hospital, pharmacy, etc.). More specifically, medical information may include information (medical information, examination information, prescription information) input into a hospital information system (medical institution system 21) such as an electronic medical record during medical treatment at a hospital, information (dispensing information) input into the medical institution system 21 when dispensing at a pharmacy, information (specific medical checkup information) input into a medical checkup system (medical institution system 21) during a medical checkup, and other information (medical fee notification information) input in administrative processing associated with the provision of medical care.

[0019] Preferably, the integrated repository 11 stores medical information in a standardized data format, which facilitates data exchange with other systems. The integrated repository 11 also stores information that can uniquely identify a patient (hereinafter referred to as a patient identifier), such as the patient's personal number (My Number), in association with the patient's medical information.

[0020] (Acquisition of medical information from medical institution system 21) When the integrated repository 11 and a medical institution system 21, which is a computer system used by a medical institution, are connected so as to be able to communicate with each other, the integrated repository 11 can acquire medical information related to a patient from the medical institution system 21. For example, the integrated repository 11 transmits a request to acquire medical information to the medical institution system 21 using a patient identifier as a key. The medical institution system 21 extracts the medical information associated with the received patient identifier and transmits it to the integrated repository 11.

[0021] The integrated repository 11 preferably has a function for reflecting the patient's intention regarding which medical information should be acquired from the medical institution system 21. FIG. 3 is an example of a screen displayed by the integrated repository 11 to confirm the patient's intention. In this screen, the patient can select whether to permit acquisition of certain medical information (opt-in) or to refuse acquisition of medical information (opt-out). When permitting acquisition of medical information (opt-in) is selected, the patient can further explicitly specify the range of medical information permitted to be acquired (e.g., type, period, etc.) and the purpose of use, etc. For example, the integrated repository 11 displays a list of types of medical information that can be acquired from the medical institution system 21 and accepts the selection of medical information permitted to be acquired. In this case, the integrated repository 11 acquires only the type of medical information selected by the patient from the medical institution system 21. Alternatively, consent to comprehensively permit acquisition of certain medical information may be obtained. In this case, the integrated repository 11 acquires medical information within the comprehensively permitted range from the medical institution system 21. On the other hand, if refusal to acquire medical information (opt-out) is selected, the integrated repository 11 will not acquire medical information from the medical institution system 21. With this mechanism, the patient can aggregate medical information in the integrated repository 11 under his / her own control.

[0022] (Obtaining medical information from medical information repository 23) In recent years, a medical information repository 23 to which one or more medical institution systems 21 are connected is in operation. For example, Mynaportal in Japan is an example. The medical information repository 23 is a computer system that collects and accumulates medical information held by each medical institution system 21. When the integrated repository 11 and the medical information repository 23 are connected to be able to communicate with each other, the integrated repository 11 can acquire medical information related to a patient from the medical information repository 23. For example, the integrated repository 11 transmits a request to acquire medical information to the medical information repository 23 using a patient identifier as a key. The medical information repository 23 extracts medical information associated with the received patient identifier and transmits it to the integrated repository 11. In this case, it is also preferable that the integrated repository 11 has a function for reflecting the patient's intention as to which medical information should be acquired from the medical information repository 23. For example, by using a method such as that shown in FIG. 3, only medical information explicitly approved by the patient can be aggregated in the integrated repository 11.

[0023] (Physical information) The physical information is information related to health that can be measured or recorded by a patient himself / herself in daily life. For example, the physical information includes a patient's life log information, health condition information, medical interview information, and the like. More specifically, the physical information may include information (life log information) that a patient records of his / her living conditions using a health care app, etc., vital data and body measurement data (health condition information) that the patient acquires using wearable devices, measuring devices, etc., and the patient's answers to health-related questions presented on an app or website (medical interview information), etc. A computer system that a patient uses to input, generate, and store such physical information is called a physical information management device 15.

[0024] The physical information management device 15 is a computer system for a patient to input, generate, and store his / her own physical information. The physical information management device 15 is, for example, a terminal device such as a personal computer (PC), a smartphone, a wearable device, or a measuring device used by the patient. Each of these terminal devices may function as the physical information management device 15 by itself, or a plurality of devices may cooperate with each other to realize the function of the physical information management device 15. For example, it is considered that an application installed on a smartphone acquires and accumulates physical measurement data such as weight and blood pressure acquired by a measuring device. In addition, some functions of the physical information management device 15 may be implemented in a server computer, a cloud computing environment, or the like that the patient can access via the terminal device. For example, the patient can use the terminal device to access a server or the like managed by a third party (such as an ePRO service provider) and directly input physical information, or transmit and accumulate physical information input or generated in the terminal device.

[0025] The physical information management device 15 provides a function for measuring health condition information. For example, the wearable device or measuring device serving as the physical information management device 15 generates vital data and body measurement data, such as heart rate, electrocardiogram, blood pressure, blood glucose level, blood oxygen concentration, weight, height, and body fat percentage, and stores the data in a predetermined storage area as physical information (health condition information). Preferably, these physical information management devices 15 input or generate physical information according to a condition specified in advance. For example, the type, granularity, measurement time period, and processing to be performed on the acquired vital data and body measurement data can be specified as conditions. For example, a schedule can be set in the wearable device to measure blood pressure at a specified time early in the morning every morning. In addition, data obtained by applying a predetermined statistical process or standardizing the vital data and body measurement data acquired by the wearable device or measuring device can be stored as physical information.

[0026] The physical information management device 15 provides a function as an interface for inputting a life log or medical interview information. For example, a PC, a smartphone, or the like serving as the physical information management device 15 displays prepared questions related to life and health on a screen, accepts input of answers to the questions, and accumulates the acquired answers in a predetermined storage area as physical information (life log or medical interview information).

[0027] Preferably, the physical information management device 15 acquires and displays questions prepared in advance by medical personnel, researchers, etc., as questions for acquiring physical information. Medical personnel, researchers, etc. use a computer system for creating questions (hereinafter, referred to as a question system) to create questions and answer formats for acquiring information related to the patient's life and health. The questions may be selected from a template prepared in advance, or may be created by free input. As the answer format, for example, a multiple-choice method (radio button, etc.), a multiple-choice method (check box, drop-down list, etc.), or a free input method (text area, etc.) is specified. In addition, a patient group to which the created questions will be distributed is specified. A patient group is, for example, a group of patients having a predetermined attribute (age, sex, etc.) or a medical condition. The patient group may be specified by specifying a combination of conditions (attributes, medical condition, etc.) prepared in advance on a GUI, or may be specified using a conditional expression or an extraction algorithm, etc. The question system identifies patients belonging to the specified patient group, and distributes questions to the physical information management device 15 of the patients. That is, the question system causes the physical information management device 15 to display the questions. The question system may be, for example, a server managed by a third party (such as an ePRO service provider). In this case, the physical information management device 15 acquires questions by connecting to the server. With this configuration, medical personnel, researchers, etc. can distribute any questions to a group of patients for whom they wish to receive answers, without relying on system vendors or medical institutions, etc. This makes it possible to collect appropriate physical information quickly and at low cost.

[0028] Preferably, the physical information management device 15 stores the physical information in a standardized data format. This makes it easy to exchange data with other systems. The physical information management device 15 also stores the physical information of the patient in association with a patient identifier such as the patient's personal number (My Number) as a key.

[0029] (Acquisition of physical information from physical information management device 15) The integrated repository 11 acquires physical information on the patient from the physical information management device 15. For example, the integrated repository 11 transmits a request to acquire medical information to the physical information management device 15 using a patient identifier such as the patient's personal number (My Number) as a key. The physical information management device 15 extracts physical information associated with the received patient identifier and transmits it to the integrated repository 11. In this case, the integrated repository 11 also preferably has a function for reflecting the patient's intention as to which physical information to acquire from the physical information management device 15. Alternatively, the physical information management device 15 may have a function for reflecting the patient's intention as to which physical information to transmit. In either case, only physical information explicitly permitted by the patient can be aggregated in the integrated repository 11 by a method such as that shown in FIG. 3.

[0030] Preferably, the integrated repository 11 stores the physical information in a standardized data format, which facilitates data exchange with other systems. The integrated repository 11 also stores a patient identifier in association with the patient's physical information.

[0031] (Information about willingness to become a subject candidate) The information regarding the willingness to become a subject candidate is information indicating whether or not the patient has the will to become a subject candidate. For example, the integrated repository 11 displays a consent screen as shown in FIG. 4. If "I agree" is selected, the integrated repository 11 stores information indicating the willingness to become a subject candidate in a storage area. On the other hand, if "I do not agree" is selected, the integrated repository 11 stores information indicating the lack of willingness to become a subject candidate in a storage area.

[0032] The integrated repository 11 stores patient identifiers in association with information regarding the intention to become a potential subject.

[0033] (Selection of subject candidates) The subject candidate extraction device 17 is a computer system that extracts desired patients as subject candidates from the integrated repository 11. The subject candidate extraction device 17 is typically a terminal device such as a personal computer (PC) or a smartphone used by a research institution such as a pharmaceutical company. Alternatively, the subject candidate extraction device 17 may be a server computer, a cloud computing environment, or the like that can be accessed by the research institution via a terminal device.

[0034] The subject candidate extraction device 17 accepts selection conditions to extract patients who are subject candidates. For example, various information included in the medical information and / or physical information can be specified as selection conditions. For example, the patient's medical condition, medical history, prescription history, dispensing history, attributes, range of physical measurement data, etc. can be specified.

[0035] Alternatively, the subject candidate extraction device 17 may extract subjects using an algorithm for extracting subject candidates suitable for a clinical trial. Such algorithms include, for example, machine learning models. When multiple algorithms are provided, the subject candidate extraction device 17 may accept a specification of the algorithm to be used.

[0036] The subject candidate extraction device 17 extracts subject candidates from a population of patients whose medical information and / or physical information is stored in the integrated repository 11 and who are willing to become subject candidates. The subject candidate extraction device 17 refers to the integrated repository 11 and extracts patients whose medical information or physical information matches specified selection conditions from the above-mentioned population. Alternatively, the subject candidate extraction device 17 uses a predetermined algorithm to extract patients who have predetermined medical information or physical information from the integrated repository 11. The subject candidate extraction device 17 outputs the extracted patients as subject candidates. For example, the extracted patients are displayed on a screen in list format.

[0037] FIG. 2 is a flowchart showing an example of the operation of the subject candidate extraction system 1.

[0038] S101:Collection of medical information The integrated repository 11 collects medical information of a patient. Typically, the integrated repository 11 acquires the medical information from a medical institution system 21 or a medical information repository 23 that collects and stores medical information from one or more medical institution systems 21. When a patient specifies in advance which type of medical information to acquire from among the medical information stored in the medical institution system 21 or the medical information repository 23, the integrated repository 11 selectively acquires only the specified medical information.

[0039] S102:Collecting physical information The physical information management device 15 collects the physical information of a patient. For example, a smartphone or wearable device with a life log app installed, a smartphone or PC (personal computer) that displays questions about a health condition and allows the user to input answers, a wearable device or measuring device that can obtain vital data, body measurement data, etc., serve as the physical information management device 15 and collect the physical information.

[0040] S103: Information aggregation into integrated repository 11 The physical information management device 15 transmits the patient's physical information at any time to the integrated repository 11. Since the physical information is transmitted in association with a patient identifier, the integrated repository 11 can store the medical information and the physical information in association with each other using the patient identifier as a key.

[0041] S104: Collection of information regarding willingness to become a potential subject The integrated repository 11 collects information indicating whether or not a patient is willing to become a potential subject.

[0042] S105: Selection of subject candidates The subject candidate extraction device 17 refers to the integrated repository 11 and extracts patients who have specified medical information and / or physical information in accordance with specified selection conditions or algorithms from a population of patients whose medical information and / or physical information is stored in the integrated repository 11 and who are willing to become subject candidates.

[0043] <Embodiment 2> 5 is a block diagram showing a configuration of a subject candidate extraction system 1 according to a second embodiment of the present invention. The subject candidate extraction system 1 differs from the first embodiment in that it includes a subject candidate repository 13. As for the other components, only the differences from the first embodiment will be described.

[0044] The subject candidate repository 13 is a computer system that manages the medical and physical information of patients who are willing to become subject candidates, extracted from the integrated repository 11. In other words, the subject candidate repository 13 stores only the medical and physical information of patients who are willing to become subject candidates.

[0045] The subject candidate extraction device 17 in the second embodiment extracts subject candidates according to specified selection conditions or algorithms from a population of patients whose medical information and physical information is stored in the subject candidate repository 13. This makes it possible to reduce the processing load related to the extraction of subject candidates compared to the first embodiment. This allows research institutions such as pharmaceutical companies to more easily extract subject candidates.

[0046] 6 is a flowchart showing an example of the operation of the subject candidate extraction system 1 according to the embodiment 2. Description of the same operations as those in the embodiment 1 will be omitted as appropriate.

[0047] S201:Collection of medical information As in S101, the integrated repository 11 acquires the medical information approved by the patient from the medical institution system 21 or the medical information repository 23.

[0048] S202:Collecting physical information As in S102, the physical information management device 15 collects the physical information approved by the patient.

[0049] S203: Information aggregation into integrated repository 11 As in S103, the physical information management device 15 transmits the physical information at any time to the integrated repository 11. The integrated repository 11 stores the medical information and the physical information in association with each other using the patient identifier as a key.

[0050] S204: Collection of information regarding willingness to become a potential subject Similar to S104, the integrated repository 11 collects information regarding the willingness of potential subjects to become subjects.

[0051] S205: Creation of subject candidate repository 13 The medical and physical information of patients who are willing to become subject candidates is extracted from the integrated repository 11, and a subject candidate repository 13 is created.

[0052] S206: Selection of subject candidates The subject candidate extraction device 17 refers to the subject candidate repository 13 and extracts patients having predetermined medical information and / or physical information according to specified selection conditions or algorithms.

[0053] According to these embodiments, research institutions such as pharmaceutical companies can access the integrated repository 11 to quickly and efficiently extract subject candidates who are likely to meet the inclusion criteria for clinical research, without going through medical institutions or the like.

[0054] Furthermore, according to these embodiments, patients can become subject candidates by providing their own medical and physical information to the integrated repository 11 without going through a medical institution. This opens the way for patients to take part in clinical trials on their own initiative, which was previously only possible through the initiative of a medical institution.

[0055] Furthermore, according to these embodiments, even without the involvement of a medical institution, a research institution or the like can explain to a patient about becoming a subject candidate, obtain the patient's consent, and manage the consent information. Conventionally, a research institution or the like had to explain to a medical institution, have the medical institution obtain the patient's consent, and manage the obtained consent information. According to the present invention, there is no need to take responsibility for introducing and maintaining a system for explanation and consent via a medical institution, and research institutions and patients can be directly connected, which can significantly reduce the effort and cost required for clinical trials.

[0056] Furthermore, according to these embodiments, patients can voluntarily collect information about themselves and decide whether or not to provide that information for screening of potential subjects, i.e., patients themselves can control the information used for screening of potential subjects.

[0057] Furthermore, according to these embodiments, research institutions such as pharmaceutical companies can extract candidate subjects with higher accuracy than before. For example, by extracting candidate subjects by combining the condition that antihypertensive drugs have been prescribed within a certain period (medical information such as PHR) with the condition that early morning blood pressure at home is high (physical information such as ePRO), it is possible to extract candidate subjects closer to the target group of a particular drug with high accuracy. This makes it possible to reach candidate subjects that could not be reached by conventional medical institution-led frameworks, and to establish a new framework for clinical trials.

[0058] Note that the present invention is not limited to these embodiments, and components can be appropriately changed, deleted, or added without departing from the spirit of the present invention. For example, in a case where the integrated repository 11 and the physical information management device 15 are provided as paid services by a third party, if a patient cooperates in a clinical trial as a subject or a potential subject, the cost of the service may be borne by the research institution such as a pharmaceutical company. Alternatively, it is also conceivable that the research institution operates the integrated repository 11 and the physical information management device 15. This makes it possible to build a new clinical trial ecosystem centered on the integrated repository 11.

[0059] It is also possible to provide a service (hereinafter, a recommendation service) that provides patients with information about clinical trials by utilizing the information stored in the integrated repository 11, the subject candidate repository 13, and the physical information management device 15. For example, a research institution or the like that is a user of the subject candidate extraction device 17 registers the contents of clinical trials that may be conducted in the future and the conditions of subject candidates required in the knowledge in a storage area not shown. As the conditions, various information included in the medical information and / or physical information can be specified. For example, the patient's medical condition, medical history, prescription history, dispensing history, attributes, range of physical measurement data, etc. can be specified. Alternatively, subjects may be extracted using an algorithm for extracting subject candidates suitable for the clinical trial. Such algorithms include, for example, machine learning models. A system of a business providing a recommendation service (hereinafter, a recommendation system) refers to the above storage area and the integrated repository 11, the subject candidate repository 13, or the physical information management device 15 of the patient, and extracts patients having predetermined medical information and / or physical information according to the conditions or algorithm. The patient is then presented with details of clinical trials that may be conducted in the future and encouraged to apply. In this case, it is preferable that the integrated repository 11 and / or the physical information management device 15 have a function for reflecting the patient's wishes regarding whether or not to provide medical information and physical information to the recommendation system. For example, by using a method such as that shown in Fig. 3, only medical information and physical information that the patient has explicitly consented to can be provided to the recommendation system.

[0060] In these embodiments, the users of the subject candidate extraction device 17 are assumed to be research institutes such as pharmaceutical companies, but the present invention is not limited to this. For example, medical device developers can use the subject candidate extraction device 17 to extract user candidates.

[0061] In the above embodiment, the present invention has been described as being mainly configured by hardware, but the present invention is not limited to this, and any process can be realized by having a CPU (Central Processing Unit) execute a computer program. In this case, the computer program can be stored using various types of non-transitory computer readable media and supplied to the computer. The non-transitory computer readable media includes various types of tangible storage media. Examples of the non-transitory computer readable media include magnetic recording media (e.g., flexible disks, magnetic tapes, hard disk drives), magneto-optical recording media (e.g., magneto-optical disks), CD-ROMs (Read Only Memory), CD-Rs, CD-R / Ws, and semiconductor memories (e.g., mask ROMs, PROMs (Programmable ROMs), EPROMs (Erasable PROMs), flash ROMs, and RAMs (random access memories)). The program may also be supplied to the computer by various types of transitory computer readable media. Examples of the transitory computer readable media include electrical signals, optical signals, and electromagnetic waves. The temporary computer-readable medium can supply the program to the computer via a wired communication path such as an electric wire or an optical fiber, or via a wireless communication path. [Explanation of symbols]

[0062] 1. Subject candidate selection system 11 Unified Repository 13. Candidate Subject Repository 15 Physical information management device 17. Subject candidate extraction device 21 Medical Institution System 23 Medical Information Repository

Claims

1. A subject candidate extraction system including an integrated repository and a subject candidate extraction device, The integrated repository includes: Medical information of the patient input or generated by a medical institution and approved in advance by the patient; Physical information of the patient input or generated by the patient and approved in advance by the patient; The patient's willingness to become a subject candidate is linked and stored, The subject candidate extraction device comprises: Extracting from the integrated repository, among the patients who are willing to become subject candidates, the patients who have the predetermined medical information and physical information according to a selection criterion or algorithm. Subject candidate extraction system.

2. The integrated repository acquires the medical information from a medical institution system or a medical information repository that aggregates the medical information created or generated by one or more medical institutions. The subject candidate extraction system according to claim 1.

3. The physical information includes life log information, health condition information, or medical interview information acquired by a physical information management device. The subject candidate extraction system according to claim 1.

4. The integrated repository accepts designation by the patient of the types of the medical information and the physical information to be subject to consent. The subject candidate extraction system according to claim 1.

5. Accept the patient's designation of the medical and physical information to be subject to consent; Collecting medical information of the patient that is the subject of the consent from among the medical information input or generated by a medical institution; Collecting the physical information of the patient that is the subject of the consent from among the physical information of the patient that has been input or generated by the patient; Collecting information regarding the patient's willingness to become a potential subject; The collected medical information, physical information, and information regarding the willingness to become a subject candidate are linked and stored. Integration Repository.

6. The repository according to claim 5 is referenced, and the patient having the predetermined medical information and physical information is extracted from the patients who are willing to become subject candidates according to a selection condition or an algorithm. Subject candidate extraction device.

7. In the integrated repository, receiving, by a patient, designation of medical information and physical information to be subject to consent; collecting medical information of the patient inputted or generated by a medical institution and previously authorized by the patient; collecting physical information of the patient inputted or generated by the patient and previously authorized by the patient; collecting information regarding the patient's willingness to become a potential subject; A step of linking and storing the collected medical information, physical information, and information regarding the willingness to become a subject candidate; In the subject candidate extraction device, Extracting the patients who have predetermined medical information and physical information from among the patients who are willing to become subject candidates according to a selection condition or algorithm. Methods for selecting potential subjects.

8. receiving, by a patient, designation of medical information and physical information to be subject to consent; collecting medical information of the patient inputted or generated by a medical institution and previously authorized by the patient; collecting physical information of the patient inputted or generated by the patient and previously authorized by the patient; collecting information regarding the patient's willingness to become a potential subject; and storing the collected medical information, physical information, and information regarding the willingness to become a subject candidate in association with each other. How to create an Integration Repository.

9. Extracting the patient having the predetermined medical information and physical information from among the patients who are willing to become subject candidates according to a selection condition or algorithm. Methods for selecting potential subjects.

10. A program for causing a computer to execute the method according to any one of claims 7 to 9.

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