Clinical trial and clinical test subject selection support system and selection support server used therefor

Abstract

To smoothly select a candidate suited to conditions for a clinical trial subject.SOLUTION: A clinical trial and test subject selection support system comprises: a candidate extraction unit 12 that extracts a candidate suited to subject conditions and notifies a pharmacy terminal 4 of the candidate, by using personal data including personal attribute information, diagnostic result information, case history information, and medication history information of potential clinical trial and test subjects; and a questionnaire answer creation unit 13 that creates answers to a questionnaire by using the personal data of the extracted candidate and the medication history information input from the pharmacy terminal 4. The clinical trial and test subject selection support system not only extracts the candidate suited to the subject conditions by using the personal data of the potential clinical trial and test subjects, but also creates the answers to the questionnaire that are to be subsequently created by the extracted candidate. The clinical trial and test subject selection support system creates the answers to the questionnaire on the basis of the accurate personal data of the candidate and the accurate medication history information additionally input from a pharmacy, and thereby can accurately determine the suitability of the candidate as a clinical trial and test subject on the basis of the details of the answers.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] The present invention relates to a selection support system for clinical trial and clinical study subjects and a selection support server used therefor, and is particularly suitable for use in a system for supporting the process of selecting subjects for a clinical trial or a clinical study (hereinafter referred to as clinical trial and clinical study subjects).

Background Art

[0002] Generally, the recruitment of clinical trial and clinical study subjects is carried out by a subject recruitment organization (PRO: Patient Recruitment Organization) commissioned by a medical institution, a pharmaceutical company, a contract research organization (CRO), a clinical trial site support organization (SMO: Site Management Organization), etc.

[0003] In order to increase the population of candidates who can be selected as subjects, the PRO widely recruits membership registrations in newspapers, magazines, television, websites, etc. Then, candidates who meet the preconditions of the clinical trial are extracted from the information (age, gender, location, allergies, past medical history, etc., outpatient history, Chinese medicine taken, etc.) obtained at the time of membership registration, and guidance for promoting participation in the clinical trial is provided. After that, by conducting questionnaires, pre-interviews, medical examinations, etc. for the candidates who responded, those who meet the subject conditions of the clinical trial are finally selected as candidates for clinical trial and clinical study subjects.

[0004] However, in recent clinical trials, the subject conditions tend to be complicated, the difficulty of extracting eligible candidates has increased, and it has become difficult to secure the required number of subjects. In particular, since questionnaires often include questions that require answers regarding specialized content and various past test results, it is difficult for candidates to enter accurate answers to all questions. Therefore, in many cases, candidates who seem to meet the subject conditions or whose eligibility for meeting the subject conditions is unclear based on the questionnaire results are excluded in subsequent pre-interviews and medical examinations.

[0005] In addition, a system for extracting subject candidates that meet the conditions from patient information such as the name of the target disease, age, and gender, prescription and dispensing information, or electronic medical record information is known (see, for example, Patent Documents 1 to 3). There is also a system for screening clinical trial subject candidates using patient information extracted from a medical fee billing system or the like (see, for example, Patent Document 4), and a system for screening clinical trial subject candidates using health examination data of various measured values (blood pressure, body temperature, weight, BMI, blood glucose level, body fat, cholesterol level, triglyceride, GOT, GPT, uric acid level, Hba1c, uric acid level, eyesight, allergy, etc.) (see, for example, Patent Document 5).

[0006] However, even if subject candidates are extracted using the systems described in Patent Documents 1 to 5, it is necessary to select those who meet the subject conditions as subjects by conducting questionnaires, pre-interviews, medical examinations, etc. afterwards, and the above-mentioned problems cannot be solved. If the response content of the questionnaire is inaccurate and progresses to subsequent pre-interviews and medical examinations, etc., and it is often judged as unsuitable as a subject there, there is a problem that waste occurs in the subject selection process and it takes a lot of time to secure the required number of subjects.

Prior Art Documents

Patent Documents

[0007]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Summary of the Invention

Problems to be Solved by the Invention

[0008] The present invention has been made to solve such problems, and an object thereof is to enable more smooth selection of candidates who meet the subject conditions of clinical trials and clinical studies.

Means for Solving the Problems

[0009] In order to solve the above-described problems, in the present invention, using personal data including personal attribute information of a preliminary group of clinical trial and clinical study subjects, diagnostic result information of medical examinations or health checkups, medical history information, and medication history information, candidates who meet the set subject conditions are extracted, information on the extracted candidates is notified to the dispensing pharmacy terminal, and using the personal data of the extracted candidates and additional medication history information input from the dispensing pharmacy terminal, a questionnaire response is generated.

Effects of the Invention

[0010] According to the present invention configured as described above, not only are candidates who meet the subject conditions extracted using personal data previously stored for a preliminary group of clinical trial and clinical study subjects, but a questionnaire response that the extracted candidates will create later is also generated. The content of the questionnaire response is generated based on accurate personal data including the personal attribute information, diagnostic result information, medical history information, and medication history information of the candidate, and accurate medication history information additionally input from the dispensing pharmacy terminal. Therefore, based on the content of the questionnaire response, it is possible to accurately determine the suitability as a clinical trial and clinical study subject. As a result, it is possible to suppress the occurrence of waste such that the candidate selection process for candidates who do not have suitability as a clinical trial and clinical study subject proceeds from the questionnaire first, and it becomes possible to more smoothly select candidates who meet the subject conditions.

Brief Description of the Drawings

[0011]

Figure 1

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Mode for Carrying Out the Invention

[0012] (First Embodiment) Hereinafter, a first embodiment of the present invention will be described with reference to the drawings. FIG. 1 is a diagram showing an overall configuration example of a clinical trial / clinical trial subject selection support system (hereinafter referred to as a subject selection support system) according to the first embodiment.

[0013] As shown in FIG. 1, the subject selection support system according to the first embodiment includes a selection support server 1, a personal data management server 2, a PRO server 3, and a dispensing pharmacy terminal 4 used in a plurality of dispensing pharmacies. The selection support server 1, the personal data management server 2, the PRO server 3, and the dispensing pharmacy terminal 4 are connected to a communication network 10 such as the Internet or a mobile phone network.

[0014] The personal data management server 2 is equipped with a personal data storage unit 20, and stores and manages the personal data of the preliminary group of subjects in clinical trials and clinical studies in the personal data storage unit 20. The preliminary group of subjects in clinical trials and clinical studies is, for example, users who use the medicine diary app. The medicine diary app is an application of a medicine diary that can be downloaded and used on a smartphone, and has as its basic function the recording of when, where, what medicine, and how much was prescribed. In addition to the basic function, the medicine diary app has various functions, including a function to send a prescription and make a dispensing reservation, a function to manage the medicine taking period and taking records, etc. using a calendar, and a function to record and manage information such as blood pressure, blood glucose level, pulse rate, body weight, body fat percentage, body temperature, physical condition, and diet content.

[0015] Personal data is, for example, data uploaded to the personal data management server 2 through the medicine diary app, and includes personal attribute information, diagnostic result information of medical examinations or health check-ups, medical history information, and medicine history information. These information include, in addition to the information recorded in the medicine diary app, information obtained by the medicine diary app in cooperation with servers of related institutions such as the My Number Portal, medical institutions, and dispensing pharmacies. As an example, the following information is stored in the personal data storage unit 20.

[0016] ◇ Basic information (name, gender, age, date of birth, blood type, height, weight, BMI, location, nationality, etc.) ◇ Measurement information or input information such as blood pressure, blood glucose level, pulse rate, body weight, body fat percentage, body temperature, atopy, physical condition, diet content, activity (work, bathing, etc.) ◇ Allergy·past medical history, pregnancy·lactation, hospital visit history (prescribing medical institution, dispensing pharmacy), vaccination history, presence or absence of smoking (smoking cessation period), presence or absence of wearing glasses·contact lenses, clinical trial history, etc. ◇ Medication history of prescribed·dispensed pharmaceuticals, OTC pharmaceuticals, or supplements (medicine information, dispensing date, usage, dosage, start date / end date of taking, etc.) ◇ Information on examination results including specific medical examinations (blood test results and various evaluations, metabolic syndrome determination, interview results by the examinee, subjective symptoms, medical history, etc.) ◇ Electronic medical record information managed by pharmacies (dispensing history, patient status at the time of medication guidance, usage status of OTC drugs and supplements, content of injections, infusions, and treatments at medical institutions, etc.) ◇ Information such as various test results and disease information managed by medical institutions (specimen test results, various evaluations, disease-related information, etc.)

[0017] The PRO server 3 is equipped with a subject condition storage unit 30, which stores and manages information indicating the subject conditions of the clinical trial. The PRO server 3 publicly discloses at least a part of these subject conditions on a website or the like to widely recruit membership registrations. The subject conditions are also used in the candidate extraction process that is performed before narrowing down the candidates for the clinical trial / clinical trial subjects based on the answers to the questionnaire. That is, the subject conditions are used as the eligibility conditions (i.e., the subject conditions to be satisfied before the implementation of the questionnaire) for extracting candidates who may become clinical trial / clinical trial subjects from the database of the personal data storage unit 20 that stores personal data, and the content thereof is arbitrarily set by the PRO according to the clinical trial to be implemented.

[0018] The subject conditions relate to a part of various information included in the above-mentioned personal data. For example, in a Phase I trial conducted to confirm safety such as side effects for a small number of healthy people, subject conditions are set regarding any of age, gender, location, nationality, weight, BMI, presence or absence of smoking (smoking cessation period), drug withdrawal period, presence or absence of wearing glasses or contact lenses, etc.

[0019] Also, in a Phase II trial conducted to confirm an effective and safe dosage and dosing method for a small number of patients, or in a Phase III trial conducted to compare the effectiveness and safety with an existing drug for a large number of patients, for example, in addition to the conditions used in the Phase I trial, subject conditions are set including conditions regarding the specified disease, the drugs being taken, the specified test values, etc. Note that what and how to set the subject conditions in the Phase I to Phase III trials are arbitrarily determined by the PRO as described above.

[0020] The subject conditions set here include extraction conditions and exclusion conditions. The extraction conditions are the conditions indicating that those who meet these conditions are to be extracted as candidates. On the other hand, the exclusion conditions are the conditions indicating that those who meet these conditions are to be excluded from the candidates. When a plurality of extraction conditions and a plurality of exclusion conditions are set, those who meet all the extraction conditions and do not meet all the exclusion conditions will be extracted as candidates for the clinical trial subjects.

[0021] Based on the personal data of the preliminary group of clinical trial subjects stored in the personal data storage unit 20, the selection support server 1 performs a process of extracting candidates who meet the subject conditions stored in the subject condition storage unit 30 from the preliminary group of clinical trial subjects. In addition, the selection support server 1 also performs a process of generating answers to the questionnaire to be conducted on the candidates as part of the selection process of the clinical trial subjects in cooperation with the dispensing pharmacy terminal 4. The details of the processes performed by this selection support server 1 will be described with reference to FIG. 2 below.

[0022] FIG. 2 is a block diagram showing a functional configuration example of the selection support server 1 according to the first embodiment. As shown in FIG. 2, the selection support server 1 according to the first embodiment includes, as a functional configuration, a subject condition acquisition unit 11, a candidate extraction unit 12, and a questionnaire answer generation unit 13. The questionnaire answer generation unit 13 includes, as a more specific functional configuration, a provisional answer generation unit 13a and a confirmed answer generation unit 13b.

[0023] The above functional blocks 11 to 13 can be configured by any of hardware, DSP (Digital Signal Processor), and software. For example, the above functional blocks 11 to 13 are realized by the operation of a program stored in a storage medium such as a RAM, a ROM, a hard disk, or a semiconductor memory under the control of a microcomputer configured with a CPU, a RAM, a ROM, etc.

[0024] The subject condition acquisition unit 11 accesses the PRO server 3 and acquires the information on the subject conditions stored in the subject condition storage unit 30. The candidate extraction unit 12 accesses the personal data management server 2, and uses the personal data of the pre-group of subjects for clinical trials stored in the personal data storage unit 20 to extract candidates who meet the subject conditions acquired by the subject condition acquisition unit 11 from the pre-group of subjects for clinical trials, and notifies the dispensing pharmacy terminal 4 of the information on the extracted candidates.

[0025] Here, as described above, the candidate extraction unit 12 searches the personal data in the personal data storage unit 20 for persons who meet all of the plurality of extraction conditions included in the subject conditions and do not meet all of the plurality of exclusion conditions, and extracts one or more such persons as candidates for subjects in clinical trials.

[0026] In addition, the candidate extraction unit 12 refers to the information on the hospital visit history included in the personal data of the extracted candidates, and notifies the dispensing pharmacy terminal 4 of the information on the candidates for the dispensing pharmacy recorded as the hospital visit history. The information on the candidates to be notified may be any information that can identify the corresponding candidates from among the patients for whom the dispensing pharmacy has dispensed drugs in the past, such as name, gender, date of birth, location, etc.

[0027] In the database of the dispensing pharmacy terminal 4 to which the information on the candidates is notified by the candidate extraction unit 12 or a pharmacy internal management server (not shown) connected thereto, the drug history information of the drugs that have been dispensed to the candidates in the past is recorded. The dispensing pharmacy terminal 4 that has received the notification of the candidates inputs the drug history information of the candidates based on the operation of the pharmacy staff and transmits it to the selection support server 1. Alternatively, the dispensing pharmacy terminal 4 may automatically search the database for the drug history information of the candidates based on the information on the candidates received from the selection support server 1, input it, and transmit it to the selection support server 1.

[0028] The questionnaire response generation unit 13 generates questionnaire responses using the personal data of the candidates extracted by the candidate extraction unit 12 and additional medication history information input from the dispensing pharmacy terminal 4. The medication history information of the candidates input from the dispensing pharmacy terminal 4 may include information not included in the personal data of the candidates stored in the personal data storage unit 20. Therefore, the questionnaire response generation unit 13 generates questionnaire responses using the additional medication history information input from the dispensing pharmacy terminal 4 in addition to the personal data of the candidates.

[0029] The questionnaire response generation unit 13 stores form data of a questionnaire including a plurality of questions, and generates questionnaire responses by setting responses for each of the plurality of questions. The plurality of questions include either or both of a selection type in which one is selected from a plurality of options for answering and a description type in which an arbitrary character or number is described for answering.

[0030] For selection type questions, a selection algorithm is preset for which information among the personal data of the candidates and the additional medication history information to refer to and how to select options according to the referred information. For description type questions, a description algorithm is preset for which information among the personal data of the candidates and the additional medication history information to refer to and how to describe using the referred information. The questionnaire response generation unit 13 sets responses for each of the plurality of questions according to these selection algorithms and description algorithms.

[0031] Note that even if additional medication history information is supplemented to the personal data of the candidates, there may still be a possibility that the information required to answer all the questions of the questionnaire is not complete. Therefore, in this embodiment, the questionnaire responses can be generated by adding information supplemented by the candidates themselves. The mechanism is realized by the provisional response generation unit 13a and the confirmed response generation unit 13b.

[0032] The provisional response generation unit 13a generates a provisional version of the questionnaire response using the personal data of the candidates extracted by the candidate extraction unit 12 and the additional medication history information input from the dispensing pharmacy terminal 4. For example, as described above, when the dispensing pharmacy terminal 4 receives a notification of a candidate from the candidate extraction unit 12, the dispensing pharmacy terminal 4 uploads the medication history information of the candidate to the selection support server 1. The provisional response generation unit 13a uses the uploaded medication history information of the candidate and the personal data of the candidate stored in the personal data storage unit 20 to generate a provisional version of the questionnaire response with responses to the questions set within the range where responses are possible.

[0033] Alternatively, the following method may be used. That is, the provisional response generation unit 13a first generates a primary questionnaire response with responses to the questions set within the range where responses are possible using the personal data of the candidate, and notifies the dispensing pharmacy terminal 4 of the generated primary questionnaire response information. At the dispensing pharmacy that receives this notification at the dispensing pharmacy terminal 4, the content of the primary questionnaire response is visually confirmed to identify unanswered questions. Then, the dispensing pharmacy terminal 4 designates and uploads to the selection support server 1 the medication history information useful for answering the unanswered questions. The provisional response generation unit 13a uses the uploaded medication history information to generate a provisional version of the questionnaire response by additionally setting responses to the unanswered questions in the primary questionnaire response.

[0034] The definitive response generation unit 13b generates a definitive version of the questionnaire response based on the provisional version of the questionnaire response generated by the provisional response generation unit 13a, using the acquisition information input from the dispensing pharmacy terminal 4 based on the information obtained by the dispensing pharmacy that has received the candidate's notification from the candidate. For example, the provisional version of the questionnaire response information generated by the provisional response generation unit 13a is notified to the dispensing pharmacy terminal 4. At the dispensing pharmacy that has received this notification at the dispensing pharmacy terminal 4, the content of the provisional version of the questionnaire response is visually confirmed to grasp the unanswered questions. Then, information useful for answering the unanswered questions is obtained from the candidate, input into the dispensing pharmacy terminal 4, and uploaded to the selection support server 1. The definitive response generation unit 13b generates a definitive version of the questionnaire response by additionally setting answers to the unanswered questions in the provisional version of the questionnaire response using this uploaded acquisition information.

[0035] Specifically, at the dispensing pharmacy that has received the candidate's notification from the candidate extraction unit 12 at the dispensing pharmacy terminal 4, when the candidate visits the dispensing pharmacy for a new dispensing purpose or makes a dispensing reservation later, an explanation about the clinical trial is given. Alternatively, the dispensing pharmacy may contact the candidate by means such as phone or email to explain the clinical trial. After confirming that the candidate has the intention to become a subject in the clinical trial, inquiries are made about matters not recorded in the dispensing pharmacy's medication history information (for example, the medication status of drugs prohibited during the clinical trial), and the information obtained thereby is input into the dispensing pharmacy terminal 4 and uploaded to the selection support server 1.

[0036] The definitive response generation unit 13b generates a definitive version of the questionnaire response using this uploaded acquisition information. Although the information used to generate the definitive version of the questionnaire response is obtained from the candidate, it is information obtained through inquiries by the dispensing pharmacy, so it can be said to be objective and useful information for creating the response.

[0037] The questionnaire response information generated by the questionnaire response generation unit 13 is provided to the PRO. For example, it can be configured such that the PRO can access the candidate selection support server 1 from the terminal used by the PRO to obtain the questionnaire response information. Alternatively, the questionnaire response information generated by the questionnaire response generation unit 13 may be provided to the PRO server 3, and the PRO may access the PRO server 3 from the terminal used by the PRO to obtain the questionnaire response information. Based on the content of the accurately generated questionnaire responses, the PRO can determine whether a candidate is suitable as a subject in a clinical trial or clinical study, and can proceed with the subsequent candidate selection processes such as pre-interview and medical examination only for those who are recognized as suitable.

[0038] Figure 3 is a flowchart showing an operation example of the candidate selection support server 1 and the dispensing pharmacy terminal 4 according to the first embodiment configured as described above. First, the subject condition acquisition unit 11 of the candidate selection support server 1 accesses the PRO server 3 and acquires the information on the subject conditions stored in the subject condition storage unit 30 (step S1). Next, the candidate extraction unit 12 accesses the personal data management server 2 and extracts candidates who meet the subject conditions acquired by the subject condition acquisition unit 11 using the personal data of the preliminary group of clinical trial and clinical study subjects stored in the personal data storage unit 20 (step S2), and notifies the dispensing pharmacy terminal 4 of the information on the extracted candidates (step S3).

[0039] Upon receiving the notification of the candidate, the dispensing pharmacy terminal 4 uploads the medication history information of the candidate to the candidate selection support server 1 (step S4). The provisional response generation unit 13a of the candidate selection support server 1 generates a provisional version of the questionnaire response that sets the responses to the questions within the range that can be answered using the uploaded medication history information of the candidate and the personal data of the candidate stored in the personal data storage unit 20 (step S5), and notifies the dispensing pharmacy terminal 4 of the generated provisional questionnaire response information (step S6).

[0040] After that, at the dispensing pharmacy terminal 4, the information obtained by interviewing the candidate is input, and it is determined whether an upload instruction has been given (step S7). If an upload instruction has been given, the dispensing pharmacy terminal 4 uploads the acquired information from the input candidate to the selection support server 1 (step S8). The confirmed answer generation unit 13b generates a confirmed version of the questionnaire answer by using the uploaded acquired information to additionally set answers to the unanswered questions in the provisional version of the questionnaire answer (step S9). Thereby, the processing of the flowchart shown in FIG. 3 ends.

[0041] As described in detail above, in the first embodiment, the selection support server 1 extracts candidates who meet the subject conditions by using the personal data of the pre-group of subjects in clinical trials and clinical trials, and notifies the dispensing pharmacy terminal 4 of the information of the extracted candidates. Then, the questionnaire answers are generated by using the personal data of the extracted candidates and the additional medication history information input from the dispensing pharmacy terminal 4.

[0042] According to the first embodiment configured as described above, not only are candidates who meet the subject conditions extracted by using the personal data stored in advance for the pre-group of subjects in clinical trials and clinical trials, but also the questionnaire answers that the extracted candidates will create later are generated. The content of the questionnaire answer is generated based on the accurate personal data including the candidate's personal attribute information, diagnosis result information, medical history information, and medication history information, and the accurate medication history information additionally input from the dispensing pharmacy terminal 4. Therefore, the suitability as a subject in clinical trials and clinical trials can be accurately determined based on the content of the questionnaire answer. As a result, it is possible to suppress the occurrence of waste such that the subject selection process for candidates who do not have suitability as a subject in clinical trials and clinical trials proceeds earlier from the questionnaire, and it becomes possible to more smoothly select candidates who meet the subject conditions.

[0043] (Second Embodiment) Next, a second embodiment of the present invention will be described with reference to the drawings. The second embodiment further includes a function for more easily securing the required number of subjects for clinical trials and clinical study subjects.

[0044] FIG. 4 is a diagram showing an example of the overall configuration of a subject selection support system according to the second embodiment. In this FIG. 4, components having the same functions as those shown in FIG. 1 are denoted by the same reference numerals. As shown in FIG. 4, the subject selection support system according to the second embodiment includes a selection support server 1' instead of the selection support server 1, and further includes a CRO terminal 5 used by a CRO or the like that requests a clinical trial or a clinical study.

[0045] FIG. 5 is a block diagram showing an example of the functional configuration of the selection support server 1' according to the second embodiment. In this FIG. 5, those denoted by the same reference numerals as those shown in FIG. 2 have the same functions, and thus redundant descriptions are omitted here. As shown in FIG. 5, the selection support server 1' according to the second embodiment further includes a condition setting unit 14 and a search unit 15 as functional configurations.

[0046] The condition setting unit 14 arbitrarily sets subject conditions according to the designation of a CRO that operates the CRO terminal 5. As described above, the subject conditions set by the CRO include extraction conditions and exclusion conditions related to at least a part of personal attribute information, diagnosis result information of a medical examination or a health check, medical history information, and medication history information. Among these, the extraction conditions are set to be variable. The fact that the setting is variable means that the CRO can relax the conditions while confirming the search results (described later) by the search unit 15. On the other hand, the exclusion conditions are set to be non-variable, and it is assumed that the conditions cannot be relaxed.

[0047] FIG. 6 is a diagram showing an example of a condition setting screen provided to the CRO terminal 5 by the condition setting unit 14. The condition setting screen shown in FIG. 6 includes a subject target number setting column 601, an extraction condition initial setting column 602, an extraction condition variable setting column 603, an exclusion condition setting column 604, a corresponding number display column 605, and a confirmation button 606.

[0048] The subject target number setting field 601 is an input field for setting the target number of subjects to be selected for the clinical trial or clinical study. The CRO inputs an arbitrary subject target number into the subject target number setting field 601.

[0049] The extraction condition initial setting field 602 is an input field for setting the initial setting values of the extraction conditions. The CRO initially sets the extraction conditions by selecting any one or more information items from the personal attribute information, diagnosis result information, medical history information, and medication history information. FIG. 6 shows an example of the state where the extraction conditions are initially set for four information items: location, BMI, smoking duration, and drug withdrawal period.

[0050] The extraction condition variable setting field 603 is an input field for setting the variable setting values of the extraction conditions. The CRO makes settings for relaxing the conditions as needed for the extraction conditions of the one or more information items that have been initially set. In the example of FIG. 6, for each of the four information items, a plurality of relaxation conditions that can be set by checking a checkbox are presented as options. The number of subjects in the preliminary group for the clinical trial or clinical study corresponding to each relaxation condition is also displayed.

[0051] For example, regarding the extraction condition of location, which is initially set to "Fukuoka City, Fukuoka Prefecture", it is shown that there are 12 people whose location is within 1 hour from there, 17 people whose location is within 1.5 hours from there, and 30 people whose location is within 2 hours from there. The number of people corresponding to these relaxation conditions is obtained by the search unit 15 searching the personal data in the personal data storage unit 20. The same applies to the other information items (BMI, smoking duration, drug withdrawal period).

[0052] The exclusion condition setting column 604 is an input column for setting exclusion conditions. The CRO selects any one or more information items from the personal attribute information, diagnosis result information, medical history information, and medication history information to set the exclusion conditions. FIG. 6 shows an example of the state where two exclusion conditions are set. Note that the exclusion condition setting column 604 may be configured to present a plurality of prepared exclusion conditions as options in the form of a pull-down menu or a pop-up menu, etc., and the exclusion conditions may be set by selecting any one from the options.

[0053] The applicable number display column 605 displays the number of subjects in the preliminary group of the clinical trial / subject of the clinical trial who meet the subject conditions set in the extraction condition initial setting column 602, the extraction condition variable setting column 603, and the exclusion condition setting column 604. In the example of FIG. 6, the number of applicable persons retrieved by the search unit 15 with the extraction conditions initially set in the extraction condition initial setting column 602 and the exclusion conditions set in the exclusion condition setting column 604 as an AND condition, and the number of applicable persons retrieved by the search unit 15 with the relaxed extraction conditions variably set in the extraction condition variable setting column 603 and the exclusion conditions set in the exclusion condition setting column 604 as an AND condition are displayed. The numbers in parentheses are the difference in the number of subjects from the target number of subjects set in the subject target number setting column 601.

[0054] The search unit 15 uses the personal data stored in the personal data storage unit 20 to search for the persons who meet the subject conditions set by the condition setting unit 14, obtains the number of applicable persons, and displays the result in the applicable number display column 605. As described above, the search unit 15 searches for the applicable persons with the initially set extraction conditions and exclusion conditions as an AND condition and displays the number of applicable persons, and when relaxation conditions are set, searches for the applicable persons with the relaxed extraction conditions and exclusion conditions as an AND condition and displays the number of applicable persons. In addition, the search unit 15 searches for the applicable persons for each of the plurality of relaxation conditions presented as options for each of the initially set one or more information items, and extracts the number of applicable persons and displays it in the extraction condition variable setting column 603.

[0055] While checking the number of eligible subjects displayed in the extraction condition variable setting field 603 and the eligible subject number display field 605, the CRO variably sets the extraction conditions so that the number of eligible subjects for the subject conditions is equal to or greater than the target number of subjects, and then operates the confirmation button 606. When the confirmation button 606 is operated, the subject conditions set at that time are transmitted to the PRO server 3 and stored in the subject condition storage unit 30. The candidate extraction unit 12 uses the personal data stored in the personal data storage unit 20 to extract candidates that meet the subject conditions set by the condition setting unit 14, including the extraction conditions variably set so that the number of eligible subjects is equal to or greater than the target number of subjects.

[0056] According to the second embodiment configured as described above, after grasping in advance the situation of how many subjects who meet the subject conditions are included in the preliminary group of subjects for clinical trials and clinical trials, the candidate extraction unit 12 can appropriately set the subject conditions so that the number of candidates extracted is equal to or greater than the target number of subjects. In addition, it is possible to variably set relaxation conditions for each of one or more information items set as extraction conditions, and automatically search for and present the number of eligible subjects for each of the plurality of relaxation conditions presented as options, so it is possible to predict how much the number of eligible subjects will increase if the extraction conditions of which information item are relaxed to what extent, and it is easy to set appropriate extraction conditions. Then, the process of the candidate extraction unit 12 can be performed based on the subject conditions set in this way. In addition, recruitment for membership registration can be carried out on a website or the like based on the subject conditions set in this way.

[0057] In addition, in the above second embodiment, it may be possible to further set the database search conditions when extracting candidates from the preliminary group of subjects for clinical trials and clinical trials. For example, it may be possible to set a search condition to limit the search to those who have obtained prior confirmation of intent that they may become candidates for subjects in clinical trials and clinical trials if selected by the subject selection support system. Also, it may be possible to set a search condition to exclude those who have already been extracted and limit the search to only those who have not been extracted.

[0058] FIG. 7 is a diagram showing another example of the condition setting screen provided to the CRO terminal 5 by the condition setting unit 14. The condition setting screen shown in FIG. 7 further includes a search condition setting field 701. In the example of FIG. 7, an example is shown that includes both a check box for instructing whether to perform a search limited to those who have obtained prior consent and a check box for instructing whether to perform a search limited to only those who have not been extracted, but only one of them may be used.

[0059] The prior consent can be obtained, for example, by displaying an inquiry screen in the medicine diary application. The medicine diary application stores flag information indicating whether there is an intention to become a candidate for a clinical trial subject based on the response from the user input through the inquiry screen, and uploads the personal data including this flag information to the personal data management server 2. In the search condition setting field 701, when it is instructed to perform a search limited to those who have obtained prior consent (when the check box is checked), the candidate extraction unit 12 extracts candidates who meet the subject conditions with only those who have the flag information indicating consent as the search target.

[0060] By doing so, among the preliminary group of clinical trial subjects, especially those who have obtained prior consent, the situation of how many people who meet the subject conditions are included can be grasped in advance, and the subject conditions can be appropriately set so that the number of candidates extracted by the candidate extraction unit 12 is equal to or more than the target number of subjects. As a result, it is possible to reduce the possibility that although candidates who meet the subject conditions are extracted by the subject selection support system, no agreement can be obtained for them to become subjects, and it becomes possible to more smoothly select candidates who can become subjects.

[0061] Also, when the candidate extraction unit 12 extracts candidates in response to the operation of the confirmation button 606, the candidate extraction unit 12 notifies the extracted candidates to the personal data management server 2. The personal data management server 2 sets extracted flag information in the personal data of the notified candidates. After that, when it is instructed to perform a search limited to only non-extracted persons in the search condition setting field 701, the candidate extraction unit 12 extracts candidates who meet the subject conditions, targeting only those without the extracted flag information set.

[0062] Note that the method for identifying non-extracted persons is not limited to the above example. For example, it may be as follows. That is, the candidate extraction unit 12 sets and stores the extracted flag information in association with the personal ID (common to that used by the personal data management server 2) that identifies the extracted candidates. After that, when it is instructed to perform a search limited to only non-extracted persons in the search condition setting field 701, the candidate extraction unit 12 uses the stored personal ID and the extracted flag information to perform a search targeting only those without the extracted flag information set.

[0063] By doing the above, for example, when re-executing the extraction of candidates by changing the subject conditions, etc., it is possible to prevent already extracted persons from being extracted repeatedly. Also, even when re-executing the extraction of candidates under the same subject conditions as the previous time after the personal data of the pre-group of clinical trial subjects is additionally stored in the personal data storage unit 20, it is possible to prevent already extracted persons from being extracted repeatedly.

[0064] In addition, for example, after starting a clinical trial or a clinical study, if some subjects drop out and the number of subjects becomes insufficient, both a search condition that limits the search to those who have given prior consent and a search condition that limits the search to only those who have not been extracted are set and the search is executed. By doing so, it becomes possible to extract candidates who meet the subject conditions and who are less likely to be in a state where consent cannot be obtained, and quickly fill the shortage of subjects. In this case, since the CRO is extracting candidates, the PRO who has received a request to contact the extracted candidates contacts the candidates to explain the clinical trial or clinical study, and may confirm the intention to become a subject of the clinical trial or clinical study.

[0065] In the above-described first and second embodiments, an example in which the selection support server 1 and the personal data management server 2 are configured separately has been described, but the present invention is not limited to this. For example, the personal data management server 2 may be provided with the functions of the selection support server 1.

[0066] Also, in the above-described first and second embodiments, a configuration in which the questionnaire response generation unit 13 includes a provisional response generation unit 13a and a confirmed response generation unit 13b has been described, but the present invention is not limited to this. For example, the questionnaire response generation unit 13 may include only the functions of the provisional response generation unit 13a, and the questionnaire response generated by the provisional response generation unit 13a may be presented to the PRO based on the consent of the candidate. In this case, although the questionnaire response may not have answers set for some questions, it is possible to determine the suitability as a subject of a clinical trial or clinical study based on the answer contents of the other questions.

[0067] Furthermore, each of the above-described embodiments merely shows an example of implementation of the present invention, and the technical scope of the present invention should not be construed in a limited manner by this. That is, the present invention can be implemented in various forms without departing from the gist or the main features thereof.

Explanation of Reference Numerals

[0068] 1, 1’ Selection support server 2 Personal Data Management Server 3 PRO Server 4 Dispensing Pharmacy Terminal 5 CRO Terminal 11 Subject Condition Acquisition Unit 12 Candidate Extraction Unit 13 Questionnaire Response Generation Unit 13a Provisional Response Generation Unit 13b Definitive Response Generation Unit 14 Condition Setting Unit 1 15 Search Unit

Claims

1. A personal data storage unit that stores personal data including personal attribute information of a preliminary group of subjects in clinical trials and clinical studies, diagnostic result information of medical examinations or health check-ups, medical history information, and medication history information; A candidate extraction unit that uses the personal data stored in the personal data storage unit to extract candidates who meet the set subject conditions, and notifies the dispensing pharmacy terminal of the information of the extracted candidates; An inquiry response generation unit that generates an inquiry response using the personal data of the candidates extracted by the candidate extraction unit and additional medication history information input from the dispensing pharmacy terminal. A system for assisting in the selection of subjects in clinical trials and clinical studies, characterized by the above.

2. The above inquiry response generation unit A provisional response generation unit that generates a provisional version of the inquiry response using the personal data of the candidates extracted by the candidate extraction unit and the additional medication history information input from the dispensing pharmacy terminal; A final response generation unit that generates a final version of the inquiry response based on the provisional version of the inquiry response using the acquired information input from the dispensing pharmacy terminal based on the information obtained by the dispensing pharmacy that uses the dispensing pharmacy terminal that received the above notification from the candidate. The system for assisting in the selection of subjects in clinical trials and clinical studies according to Claim 1, characterized by the above.

3. A condition setting unit that includes the extraction conditions and exclusion conditions of the above subjects as the subject conditions, and sets the subject conditions with the extraction conditions variable; A search unit that uses the personal data stored in the personal data storage unit to search for persons who meet the subject conditions set by the condition setting unit and obtains the number of such persons; The candidate extraction unit uses the personal data stored in the personal data storage unit to extract candidates who meet the subject conditions set by the condition setting unit, including the extraction conditions variably set so that the number of such persons is equal to or greater than the target number of subjects. The system for assisting in the selection of subjects in clinical trials and clinical studies according to Claim 1 or 2, characterized by the above.

4. The condition setting unit can further set the search conditions when the candidate extraction unit extracts candidates who meet the subject conditions; The search conditions are at least one of a search condition for limiting the search to persons who have obtained prior consent to be candidates for the subjects in the clinical trials and clinical studies, and a search condition for limiting the search to only those who have not been extracted. The subject selection support system for clinical trials and clinical test subjects according to claim 3, characterized in that...

5. Using a database that stores personal data including personal attribute information, diagnosis result information of medical check-ups or health check-ups, medical history information, and medication history information of a preliminary group of clinical trial and clinical test subjects, extracting candidates who meet the set subject conditions, and a candidate extraction unit that notifies the information of the extracted candidates to a dispensing pharmacy terminal; A questionnaire response generation unit that generates questionnaire responses using the personal data of the candidates extracted by the candidate extraction unit and additional medication history information input from the dispensing pharmacy terminal. The subject selection support server for clinical trials and clinical test subjects, characterized in that...

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