JP2008186039A - Subject recruitment method, mediator server, software, and recording medium - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a subject recruitment method capable of efficiently selecting proper subjects highly precisely for every clinical trial. <P>SOLUTION: A server of a mediator 10 has: a step (a) of presenting a recruitment image in which the mediator 10 shows recruitment contents through the Internet 18 to urge a wisher 16 to participate in a clinical trial to register; a step (b) of receiving a registration of an applicant 16, presenting clinical trial conditions to the applicant 16 and urging the applicant 16 to participate in the application; a step (c) of receiving a participation application of the applicant 16, sequentially presenting a detailed question corresponding to the clinical trial to the applicant 16, receiving an answer of the question, and sequentially repeating an operation for making the answer uncorrectable for each question; a step (d) of determining whether the applicant 16 is suitable to the clinical trial, preparing a list of clinical trial candidates from the results and allowing a clinical trial performer 14 to browse the list; and a step (e) of notifying the participation applicant of determination results of the step (d). <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention recruits subjects who voluntarily participate in clinical trials for foods, clinical trials for pharmaceuticals and target diseases, clinical trials for cosmetics, and the like, and a subject recruiting method for selecting subjects suitable for the clinical trial conditions and this method The present invention relates to an intermediary server, software, and a recording medium on which the software is recorded.

  Clinical trials (hereinafter also referred to as clinical trials) are being conducted to confirm the effectiveness and safety of health functional foods, supplements (nutritional supplements), health foods, pharmaceuticals, cosmetics, medical devices, and the like. In this trial, a sponsor such as a developer or distributor of food, cosmetics, pharmaceuticals, etc., decides the trial investigator (clinical trial institution) such as a medical institution that actually conducts the clinical trial. The practitioner becomes a practitioner and the trial practitioner conducts various trials on the subject.

JP2002-41657

  In Patent Document 1 (particularly paragraphs 0078 to 0083) as a method for selecting a subject, subjects are recruited by advertisement, the Internet, word-of-mouth, marginal relations, etc., a target subject group corresponding to the content of the trial is selected and screened, It is shown to select with consent. Since the subject information to be collected and confirmed here differs from trial to trial, lack of subject information collection should be avoided as much as possible. Therefore, in Patent Document 1, it is necessary to establish a trust relationship between the subject and the recruiter in a short conversation and to appropriately manage the questioning method (paragraphs 0082 and 0083).

  As described above, in order to obtain the subject information through the conversation with the subject in recruiting the subject in the past, the accuracy of the obtained information is likely to be uneven due to compatibility with the recruiting person and the like, and the accuracy of selecting the subject suitable for the clinical trial condition is lowered. The problem arises. Moreover, the question and answer by conversation are repeated for each subject, and the problem that efficiency is bad arises.

  This invention is made | formed in view of such a situation, and makes it the 1st objective to provide the test subject recruitment method which can select an appropriate test subject with high precision efficiently for every clinical trial. A second object is to provide an intermediary server that is directly used to implement this method. It is a third and fourth object of the present invention to provide software used for implementing this method and a storage medium storing this software.

  According to the present invention, a first object is to provide a subject recruiting method for recruiting a subject via the Internet by a mediator who introduces a subject who cooperates in a clinical trial conducted by a trial practitioner. a. A step in which an intermediary presents a recruitment screen showing contents of recruitment via the Internet and prompts a trial applicant to register; b. Receiving the applicant's registration, presenting the clinical trial conditions to the applicant, and encouraging the application for participation; c. Receiving the applicant's application for participation, presenting detailed questions corresponding to the clinical trial to the applicant in a sequential format, receiving the answers, and repeating the operation of making the previous answer uncorrectable sequentially for each question; d. Determining whether the applicant is suitable for the clinical trial and creating a list of clinical trial candidates from the results to allow review by the clinical trial practitioner; e. This is achieved by the step of notifying the participation applicant of the determination result of the step d, the subject recruiting method having the above steps a to e.

  A second purpose is a server of an intermediary used in the method of claim 1, a recruitment screen presenting section that presents a clinical trial recruitment screen showing clinical trial conditions to a terminal of a test participation applicant and urges application, Registration acceptance unit that accepts the registration application signal input from the terminal of the applicant who wants to participate, and participation conditions that accept the registration application signal and present the clinical trial conditions to the applicant's terminal that is the applicant for the clinical trial to encourage participation in the trial The presentation section, the participation application reception section that accepts the clinical trial participation application signal input from the applicant's terminal, and the detailed information corresponding to the clinical trial that accepts the participation application signal are presented to the applicant's terminal in a sequential format. A detailed question presentation unit that prompts responses and makes the previous response uncorrectable, a suitability determination unit that determines whether or not an applicant is suitable for a clinical trial, and creates a list with appropriate applicants as test candidates. Browse by the implementer And a determination result notifying unit for notifying the determination result of the suitability determining unit for each clinical trial applicant, respectively. .

  The third object is achieved by software for performing the operation of claim 1.

  The fourth object is achieved by a storage medium storing this software.

  According to the first invention, presentation of the clinical trial contents to the applicant (process a), registration of the applicant (process b), the applicant applies for participation after viewing the clinical trial conditions, and more detailed questions at this stage In response to the applicant's reaction, detailed information is sent and received in stages to obtain the applicant information. Since it did in this way, a suitable test candidate can be selected efficiently for every clinical trial. That is, at least in the recruitment stage (test candidate selection stage), it is not necessary to have a conversation between the applicant and the intermediary (recruiter), so the selection criteria can be clarified. In particular, detailed questions to be presented after applying for participation will be repeated one by one after obtaining an answer for each question and making it impossible to correct the previous answer (step c). ), Making it difficult to make dishonest answers that are intentionally matched to previous answers, making it easier to determine whether or not there are inconsistencies in many questions, and ensuring honest test applicant information. Thus, the accuracy of selecting the test candidate can be improved.

  According to the second aspect of the invention, an intermediary server that is used directly in the implementation of the first aspect of the invention is obtained. According to the third aspect, software for performing the operation of claim 1 is obtained. According to the fourth invention, a storage medium storing this software, for example, an optical disk is obtained.

  In step d of claim 1, the trial candidate list may be browsed by the trial practitioner by accessing the mediator's server via the Internet, but the trial practitioner by e-mail, facsimile, mail, etc. May be made available to the trial investigator for viewing. The mediator's server will show the results of past participants, such as past trial results such as late clinical trials, absence without notice, absence of contact, dropout / interruption during the trial, willingness to cooperate in follow-up studies, etc. It is preferable to provide data, and output reliability information based on the result data together with the list of selected test candidates (claim 2). In this case, the reliability information for each subject can be immediately known from this reliability information, and for example, it becomes one powerful reference material when the investigator selects the investigator or conducts the clinical trial.

  In the detailed question presenting process of step c, each question is displayed on the applicant's terminal as a screen, and after waiting for an answer for each question, the process proceeds to the next question (hereinafter also referred to as a sequential format). (Claim 3) If it does in this way, it will be displayed on an independent screen for every question, an applicant can be made to answer without being influenced by the questions before and behind, and it is further suitable for improvement in accuracy of candidate information.

  In step c, detailed questions prepared in advance for the applicant may be conducted to the end without interruption (claim 4). In other words, if it is found that the applicant does not meet the study conditions in the middle of the question, the question can be interrupted and the recruitment procedure can be stopped. This is because there is a risk of fraud that repeats the application.

  Further, in step e, it is preferable to notify the applicant immediately after a certain time (for example, 1 to 24 hours) without notifying the applicant of the determination result (claim 5). In this case, it is possible to prevent immediate re-application when the determination result is unacceptable, and it is possible to prevent an injustice that the application is repeated and repeated to learn and remember the question / answer.

  If the server of the second invention further has a memory for storing data (result data) indicating the results of the test experienced person, and if the result data corresponding to the list of selected test candidates is also displayed, the test candidate Therefore, it is convenient to immediately know the degree of reliability.

  FIG. 1 is a block diagram showing an embodiment of the present invention, FIG. 2 is a flowchart of the whole operation, FIG. 3 is a flowchart of a subject recruiting operation (procedure), and FIG. 4 is a signal / data transmission / reception of the subject recruiting operation. FIG. 5 and FIG. 5 are diagrams showing the configuration of the mediator server.

  In FIG. 1, reference numeral 10 denotes an intermediary server, 12 denotes a terminal of a trial requester (study requesting institution), 14 (14A, 14B,...) Denotes a terminal of the trial practitioner (trial conducting organization), 16 (16A, 16B,...) Is a terminal of an applicant who is an applicant. These are connected to each other via the Internet 18. Here, each of the terminals 12, 14, and 16 is also simply referred to as a clinical trial requester (institution), a clinical trial practitioner (institution), and a test applicant (applicant).

  The investigator's terminal 14 has a dedicated application that enables connection with the broker's server 10, and enhances the function of maintaining the confidentiality of the data of the test candidate that is transmitted to and received from the server 10. In addition, the transmission and reception of data between the server 10 and the clinical trial requester 12, the clinical trial practitioner 14, and the prospective tester 16 is performed by using encryption communication, ID (authentication code), or PW (password), thereby maintaining confidentiality. It is better to keep it higher.

  The clinical trial requester (producer or seller of pharmaceuticals or the like) 12 determines the clinical trial practitioner 14 when developing a new drug, new food, supplement, or the like (step S100 in FIG. 12). In some cases, the clinical trial requester 12 becomes the clinical trial practitioner 14 (step S102 in FIG. 2). The clinical trial client 12 presents and determines the clinical trial implementation plan (design) and summary to the clinical trial practitioner 14 (step S104).

  In other words, the selection of the investigator, the preparation of the study plan, the selection of the conducting medical institution, etc. are planned. In this design creation, the trial sponsor 12 or the practitioner 14 creates materials for obtaining approval from the partner medical institution ethics committee (IRB) and operates the IRB secretariat (step S106). As a result, when the IRB approval procedure is completed, the mediator 10 makes a meeting with the trial investigator 14 or the trial sponsor 12 as necessary (step S108). In this meeting, the intermediary 10 and the trial investigator 14 or, as necessary, the trial sponsor 12 and a confidentiality agreement or a business consignment agreement are concluded, the outline of the trial (examination) is confirmed, and the number of people, days, and clinical trials required. The cost is estimated in consideration of the difficulty.

  Next, a procedure for selecting a test candidate is started from recruitment of subjects according to the present invention (step S110), which will be described later. When a list of optimal test candidates appears in this step S110, the trial investigator 14 examines and examines the trial candidates to determine whether or not they are suitable for the trial, and details the clinical trial for the matched candidates. After confirming that the clinical trial is accepted and accepted (step S112). As a result, the trial practitioner 14 determines whether the candidate can participate in the trial (step S114). This result is sent to the server of the broker 10 and stored as performance data (step S116). The result is sent from the intermediary to the applicant 10 (step S118).

  The trial practitioner 14 conducts a clinical trial using the subjects extracted from the candidate list and monitors the progress of the clinical trial (step S120). In parallel with this execution, the mediator 10 reports and records the clinical trial participation status of the subject 16 (step S122). In other words, the attendance status of the test subject, whether or not an action such as medication, reporting or the like is taken in accordance with the instruction in compliance with the instruction of the trial investigator 14 is monitored.

  When the clinical trial is completed, the trial investigator 14 or the mediator 10 creates a clinical trial result and submits it to the clinical trial requester 12 (step S124). Further, the mediator 10 reports the clinical trial participation status of the subject 16 to the clinical trial client 12 or the clinical trial practitioner 14, and calculates and charges a fee such as a mediation fee (step S126).

(Subject recruitment procedure)
Next, the procedure for subject recruitment (step S110) will be described with reference to FIGS. The intermediary 10 regularly presents the recruitment of subjects on the homepage (HP) (step S200 in FIG. 3). Therefore, the applicant can confirm this ((1) in FIG. 4), apply in advance and register (pre-acceptance) (step S202, (2) in FIG. 4). When the intermediary 10 receives a request for investigators from the clinical trial client 12 or the clinical trial practitioner 14 and completes a procedure such as a business consignment contract (step S204, (3) in FIG. 4), the intermediary 10 revises the homepage (HP). New clinical trial contents are additionally presented (step S206, (4) in FIG. 4). The broker 10 informs the applicant (pre-applicant) who has received the advance reception (step S202) at this time by e-mail that the HP has been revised and prompts the user to view the new (revised) HP (step S207). .

  In addition, in the transmission and reception of data through the Internet 18 between the trial investigator 14 and the mediator 10, the security function is enhanced by using dedicated application software. That is, dedicated communication application software is previously input to the terminal of the trial investigator 14 and the server of the intermediary 10, respectively, so that it cannot be read by other terminals. In addition, data transmission / reception between the subject 16, the mediator 10, and the trial investigator 14 via the Internet 18 may be performed using a commonly used encryption communication function, ID (personal authentication), PW (password), or the like. Of course it is good.

  When a trial applicant (a clinical trial applicant) confirms the recruitment site of the mediator 10 ((5) in FIG. 4) and applies (step S208), the mediator 10 registers registration (application registration). (Step S210, (6) of FIG. 4). The broker 10 sends the participation condition to the applicant 16 through this application registration (step S212, (6) in FIG. 4). This participation condition is a subject of the clinical trial, that is, a clinical trial rule, a schedule, a region, whether or not to go to hospital.

  Applicant 16 sees the participation conditions and applies for participation if there is an intention to participate (step S214, (6) in FIG. 4). Upon receiving the application for participation, the mediator 10 further confirms the detailed conditions (step S216, (7) in FIG. 4). In this detailed condition confirmation, questions of items shown in “participation conditions” and exclusion conditions in FIGS. At this time, it is performed sequentially such as moving to the next question on condition that there is an answer to the question.

  It is possible that the applicant notices inconsistencies with answers to other questions and corrects the previous answer, or does not refer to the previous answer himself and declare the later answer honestly. However, the intermediary 10 determines whether the previous answer is an honest answer by making it impossible to revise the previous answer later and by preventing the previous question from being reviewed later. be able to. For this purpose, each question is presented on a different page, and the answered question cannot be reviewed later. As a result, it is possible to extract subjects with high accuracy.

  The mediator 10 server determines whether there is no contradiction or an honest answer from the series of answers ((8) in FIG. 4). As a result of the above detailed condition confirmation, it is determined whether or not participation is possible, and the result (pass / fail determination) is notified to the applicant (step S218, (9) in FIG. 4). Further, the intermediary 10 creates a list of applicants who can conduct clinical trials, that is, a list of candidate candidates (step S220, (10) in FIG. 4). The investigator 14 accesses the intermediary server 10 through the Internet 18 and browses and confirms the list of candidate candidates ((11) in FIG. 4). This list may be sent from the intermediary 10 to the trial investigator 14 by other methods such as e-mail, facsimile, mail, etc. so that the list can be viewed. Then, the trial investigator 14 examines the candidate candidates 16 who visit the hospital on the scheduled date and time, and finally judges whether or not the trial candidate is appropriate (step S112 in FIG. 2, (12) in FIG. 4). ).

  The results of this examination are collected and reported to the mediator 10 by appropriate means such as updating the data of the mediator's server 10 via e-mail, facsimile, or the Internet from the trial investigator 14 (step S116 in FIG. 2, FIG. 4). (13)). This report may be received from the subject 16. The mediator 10 creates a list of subjects based on this report and notifies the trial candidates (step S118 in FIG. 2, (14) in FIG. 4).

  The practitioner 14 conducts a clinical trial for the successful candidate (step S120 in FIG. 2), the result is reported to the mediator 10 (step S122), and the mediator 10 charges a fee (step S126, FIG. 4). (15)), the clinical trial result is received from the practitioner 14 ((16) in FIG. 4).

  In the creation of the test candidate list performed in step S220 of FIG. 3, the intermediary 10 may read the performance data for the test experienced person from the server and write the performance data for the corresponding subject 16 together. This is because the reliability of the individual subject 16 can be confirmed from the result data, and the reliability of the clinical trial results can be improved by using data obtained from highly reliable and honest participants.

(Server configuration)
Next, the configuration of the mediator server 10 shown in FIG. 1 will be described with reference to FIG. The server 10 has various functional units configured by software in order to perform the above-described processing. That is, it has the application reception part 50 corresponding to step S202, 210, 214 shown in FIG. 3, and the participation application reception part 52 corresponding to step S214.

  In addition, the recruitment screen display unit 54 corresponding to steps S200 and 206, the participation condition presentation unit 56 corresponding to step S212, the detailed question presentation unit 58 corresponding to step S216, the participation suitability determination unit 60 corresponding to step S216, and step S220. A corresponding list creating unit 62 and determination result notifying unit 64, a record data memory 66 for storing record data of past and new test experienced persons, and the like.

The block diagram which shows one Example of this invention Flow chart of overall operation Flow chart of subject recruitment operations Figure showing signal and data transmission / reception Mediation server configuration diagram Diagram showing examples of detailed questions (participation conditions and exclusion conditions) Diagram showing examples of detailed questions (participation conditions and exclusion conditions) Diagram showing examples of detailed questions (participation conditions and exclusion conditions)

Explanation of symbols

10 Broker (server)
12 Clinical trial client (terminal)
14 Clinical trial operator (terminal)
16 Applicant or applicant (terminal)
18 Internet

Claims (9)

In the subject recruiting method for recruiting a subject via the Internet by an intermediary who introduces a subject who cooperates in a clinical trial conducted by a trial investigator, the mediator's server includes:
a. A process in which an intermediary presents a recruitment screen showing the recruitment content via the Internet and prompts the prospective applicant to register;
b. The process of receiving applicant registration and presenting the clinical trial conditions to the applicant and encouraging participation application,
c. The process of receiving the applicant's participation application and presenting detailed questions corresponding to the clinical trial to the applicant in a sequential format and receiving the answers, and repeating the operation of making the previous answer uncorrectable for each question,
d. Determining whether the applicant is suitable for the clinical trial, creating a list of clinical trial candidates from the results, and allowing the trial investigator to view it,
e. A step of notifying the participation applicant of the determination result of step d;
A subject recruiting method comprising the above steps a to e.   The method for recruiting subjects according to claim 1, wherein the server of the intermediary has a memory for storing data indicating the results of the test experienced person, and outputs reliability information based on the result data to the list created in the step d. .   In step c of claim 1, the detailed question is displayed as a separate screen for each question on the trial applicant's terminal, and the next question is displayed after waiting for an answer for each question. Recruitment method.   Step c of claim 1 is a method for recruiting subjects according to claim 1, wherein a detailed question prepared in advance for an applicant is performed to the end without interruption.   The method for recruiting subjects according to claim 1, wherein, in step e of claim 1, the participant is notified after elapse of a predetermined time or more as a result of determination. An intermediary server used in the method of claim 1,
A recruitment screen presentation unit that presents an investigator recruitment screen showing the trial conditions to the terminal of the applicant who wishes to participate,
A registration accepting unit that accepts a registration application signal input from a terminal of a test applicant,
A participation condition presentation unit that accepts a registration application signal and presents the clinical trial conditions on the terminal of the applicant who is the applicant for the clinical trial,
Participation application reception part that accepts the clinical trial participation application signal input from the applicant's terminal,
A detailed question presentation unit that accepts a participation application signal and presents detailed questions corresponding to the clinical trial on the terminal of the applicant in a sequential format to prompt answers and make the previous answer uncorrectable;
A suitability determination unit that determines whether the applicant is suitable for the clinical trial,
A list creation unit that creates a list with suitable applicants as test candidates and allows the trial investigator to view the list,
A determination result notifying unit for notifying the determination result of the suitability determining unit for each clinical trial participation applicant,
A server for recruiting intermediaries for subjects.   7. The subject recruitment intermediary server according to claim 6, further comprising a memory for storing data indicating the results of the test experienced person, wherein the list creation unit displays the test experienced person's result data together with the test candidate list.   Software for performing the operation of claim 1.   A storage medium storing the software of claim 8.