JP7742145B2 - Clinical trial work support device, clinical trial work support program, and clinical trial work support method - Google Patents

Description

This disclosure relates to a clinical trial support device, a clinical trial support program, and a clinical trial support method.

During the development stage of pharmaceuticals, there is a step called clinical trials, in which effectiveness and safety are examined on humans. Clinical trials are conducted at the request of pharmaceutical companies or universities conducting drug discovery research, with the cooperation of hospitals and other medical facilities.

Clinical trial work involves a variety of tasks, such as selecting clinical trial sites, searching for potential participants, and managing the progress and promotion of clinical trial projects. For example, technology has been proposed to support the task of selecting candidate clinical trial sites, which is part of clinical trial work (Patent Document 1).

Japanese Patent Application Laid-Open No. 2004-199111

The technology described in Patent Document 1 selects candidate trial sites based on information from physicians with extensive clinical trial experience, but many other factors must be taken into consideration to ensure the smooth conduct of a clinical trial.

This disclosure has been made in consideration of the above issues, and its purpose is to support clinical trial-related tasks, not just facility selection.

According to the present disclosure, there is provided a clinical trial operation support device that supports the selection of a clinical trial site, and that includes a site selection support unit that sends clinical trial information, including items necessary for selecting a site for the clinical trial, to candidate sites, obtains responses to the items from the candidate sites, and presents the responses to the requests from the client, and the site selection support unit obtains selection information for the candidate sites from the client.

Other problems and solutions disclosed in this application will be made clear in the detailed description of the invention and drawings.

This disclosure can support clinical trial-related work.

1 is a diagram illustrating an example of the overall configuration of a health support system according to an embodiment of the present disclosure. FIG. 2 is a diagram illustrating an example of a hardware configuration of a server device 1 according to the embodiment. FIG. 2 is a diagram illustrating an example of a functional configuration of a server device 1 according to the embodiment. FIG. 10 is a diagram showing an example of the configuration of information stored in an orderer information storage unit 131 according to the embodiment. 10 is a diagram showing an example of the configuration of information stored in an implementation facility information storage unit 132 according to the embodiment. FIG. FIG. 10 is a diagram showing an example of the configuration of information stored in the clinical trial information storage unit 133 according to the embodiment. FIG. 10 is a diagram showing an example of the configuration of information stored in a response information storage unit 134 according to the embodiment. 10A and 10B show examples of information and diagrams representing the plan and progress of a clinical trial, generated by the progress information acquisition unit 118 according to the embodiment. 10 is another example of information representing the plan and progress of a clinical trial, generated by the progress information acquisition unit 118 according to the embodiment. 10 is another example of information representing the plan and progress of a clinical trial, generated by the progress information acquisition unit 118 according to the embodiment. 10 is another example of information representing the plan and progress of a clinical trial, generated by the progress information acquisition unit 118 according to the embodiment. 10 is another example of information representing the plan and progress of a clinical trial, generated by the progress information acquisition unit 118 according to the embodiment. FIG. 10 is a diagram illustrating an example of processing performed by the server device 1 according to the embodiment. FIG. 10 is another diagram showing an example of project data according to the embodiment. FIG. 10 is another diagram showing an example of project data according to the embodiment. FIG. 10 is another diagram showing an example of project data according to the embodiment. FIG. 10 is another diagram showing an example of project data according to the embodiment. FIG. 10 is another diagram showing an example of project data according to the embodiment. FIG. 10 is another diagram showing an example of project data according to the embodiment. FIG. 10 is another diagram showing an example of project data according to the embodiment.

The contents of the embodiment of the present invention will be listed and described below. One embodiment of the present invention has the following configuration.
[Item 1]
A clinical trial support device that supports the selection of clinical trial facilities,
a facility selection support unit that transmits clinical trial information including items necessary for selecting a facility for the clinical trial to the candidate facilities, obtains responses to the items from the candidate facilities, and presents the responses to the requester;
Equipped with
the implementation facility selection support unit acquires selection information of the candidates from the client;
A clinical trial support device characterized by the above.
[Item 2]
A contract support unit that supports the conclusion of a contract between the client and the implementation facility selected by the client;
2. The clinical trial support device according to item 1, comprising:
[Item 3]
an implementation facility information presentation unit that presents medical facility information including the clinical trial performance of the implementation facility to the client;
3. The clinical trial support device according to item 1 or 2, further comprising:
[Item 4]
a facility information presentation unit that determines the degree of match between the clinical trial information and the medical facility information and presents to the client medical facilities that show a degree of match equal to or greater than a predetermined value as candidate facilities;
4. The clinical trial support device according to item 3, comprising:
[Item 5]
A clinical trial support program that supports the selection of clinical trial sites,
The processor
a facility selection support step of transmitting clinical trial information including items necessary for selecting a facility for the clinical trial to the candidate facilities, obtaining responses to the items from the candidates, and presenting the responses to the orderer;
Execute
The implementation facility selection support function acquires selection information of the candidates from the client;
A clinical trial support program that features:
[Item 6]
A clinical trial support method for supporting the selection of a clinical trial site, comprising:
The processor:
a facility selection support step of transmitting clinical trial information including items necessary for selecting a facility for the clinical trial to the candidate facilities, obtaining responses to the items from the candidates, and presenting the responses to the orderer;
Run
The implementation facility selection support step includes acquiring selection information of the candidates from the client;
A clinical trial operation support method characterized by the above.
<Details of the embodiment>

Preferred embodiments of the present disclosure will be described in detail below with reference to the accompanying drawings. Note that in this specification and drawings, components having substantially the same functional configuration will be assigned the same reference numerals, and redundant explanations will be omitted.

==Overview==
Figure 1 shows the overall configuration of a clinical trial operation support system. As shown in Figure 1, the clinical trial operation support system has a server device 1, an orderer terminal 3, an order receiving person terminal 4, a clinical trial manager terminal 5, a clinical trial person terminal 6, and a collaborator terminal 7. The server device 1 is connected to the orderer terminal 3, order receiving person terminal 4, clinical trial manager terminal 5, clinical trial person terminal 6, and collaborator terminal 7 via a network 2. Although only one server device 1, orderer terminal 3, order receiving person terminal 4, clinical trial manager terminal 5, clinical trial person terminal 6, and collaborator terminal 7 are shown, it goes without saying that more than one may be present.

==Orderer Terminal 3==
The orderer terminal 3 is a computer operated by a person in charge of an orderer, such as a pharmaceutical company that orders a clinical trial, a research institution such as a university that conducts drug discovery research, or a contract research organization (CRO) that has received a commission from such an orderer. The orderer terminal 3 may be, for example, a smartphone, a tablet computer, a personal computer, or the like, but is not limited to these. The orderer can access the server device 1, for example, using an application or a web browser running on the orderer terminal 3.

==Order Receiving Personnel Terminal 4==
The order taker terminal 4 is a computer operated by an order taker in charge of accepting orders for clinical trials at a medical facility (implementation facility) such as a university hospital, hospital, or clinic where the clinical trial is conducted. This also includes cases where the order taker is operated by an order taker of an organization that supports the operations of the implementation facility, such as an SMO (Site Management Organization). The order taker terminal 4 is, for example, but is not limited to, a smartphone, tablet computer, or personal computer. The order taker can access the server device 1 using, for example, an application or web browser running on the order taker terminal 4.

As a supplementary note, in this embodiment, the processing performed by each processing unit, detailed below, on the implementation facility also includes processing performed on the SMO that supports the implementation facility's operations. The SMO, which has acquired information through the processing of the processing unit, can present the information to the implementation facility, thereby achieving the objective of this embodiment.

==Clinical Trial Manager Terminal 5==
The trial manager terminal 5 is a computer operated by the person in charge (hereinafter referred to as the trial manager; this may include a person who issues invoices, etc.) of the department that manages the clinical trial project (called the trial management office, trial secretariat, etc., but is not limited to these names) at the clinical trial facility. This also includes cases where it is operated by a trial manager such as an SMO. The trial manager terminal 5 is, for example, a smartphone, tablet computer, personal computer, etc., but is not limited to these. The trial manager can access the server device 1, for example, using an application or web browser running on the trial manager terminal 5.

==Trial investigator terminal 6==
The investigator terminal 6 is a computer operated by an investigator (referred to as a clinical trial coordinator, but not limited to this name) who promotes and manages the progress of the clinical trial project at the clinical trial facility. This also includes cases where the investigator is operated by an SMO or other investigator. The investigator terminal 6 is, for example, but is not limited to, a smartphone, tablet computer, personal computer, etc. The investigator can access the server device 1 using, for example, an application or web browser running on the investigator terminal 6.

== Collaborator Terminal 7 ==
The collaborator terminal 7 is a computer operated by collaborators, such as doctors, nurses, clinical laboratory technicians, and even companies outside the hospital, who administer medication, collect data, and perform clinical tests during the clinical trial. The collaborator terminal 7 is, for example, but is not limited to, a smartphone, a tablet computer, or a personal computer. The collaborator can access the server device 1, for example, using an application or a web browser running on the collaborator terminal 7.

In addition, since the order taker, clinical trial manager, clinical trial investigator, and collaborator may hold multiple positions, the order taker terminal 4 may also serve as one or more of the clinical trial manager terminal 5, clinical trial investigator terminal 6, and collaborator terminal 7, the clinical trial manager terminal 5 may also serve as one or more of the clinical trial investigator terminal 6 and collaborator terminal 7, and the clinical trial investigator terminal 6 may also serve as the collaborator terminal 7.

The configuration of the server device 1 is described below.

==Server Device 1==
FIG. 2 is a diagram illustrating an example of the hardware configuration of the server device 1 according to this embodiment. The server device 1 includes a processor 101, a memory 102, a storage device 103, a communication interface 104, an input device 105, and an output device 106. The storage device 103 stores various data and programs, and is, for example, a hard disk drive, a solid-state drive, or a flash memory. The communication interface 104 is an interface for connecting to the network 2, and is, for example, an adapter for connecting to Ethernet (registered trademark), a modem for connecting to a public telephone network, a wireless communication device for wireless communication, a USB (Universal Serial Bus) connector, or an RS232C connector for serial communication. The input device 105 is a device for accepting data input via, for example, a keyboard, a mouse, a touch panel, buttons, a microphone, or the like. The output device 106 is, for example, a device for outputting data, and is, for example, a display, a printer, a speaker, or the like.

Figure 3 is a block diagram showing the functional configuration of the server device 1. As shown in Figure 3, the server device 1 is configured to include processing units, namely, a purchaser information acquisition unit 111, a facility information acquisition unit 112, a clinical trial information acquisition unit 113, a questionnaire information presentation unit 114, a response information acquisition unit 115, a facility selection support unit 116, a contract support unit 117, a progress information acquisition unit 118, a progress management unit 119, a billing support unit 120, a facility information presentation unit 121, and a candidate facility selection unit 122, as well as storage units, namely, a purchaser information storage unit 131, a facility information storage unit 132, a clinical trial information storage unit 133, a response information storage unit 134, and a progress information storage unit 135.

The above-mentioned functional units are realized by the processor 101 of the server device 1 reading a program stored in the storage device 103 into the memory 102 and executing it, and the above-mentioned storage units are realized as part of the storage area provided by the memory 102 and storage device 103 of the server device 1.

Here, in this embodiment, the data configurations of the orderer information storage unit 131, implementation facility information storage unit 132, clinical trial information storage unit 133, response information storage unit 134, and progress information storage unit 135 are shown.

The orderer information storage unit 131 stores the orderer information acquired by the orderer information acquisition unit 111, an example of which is shown in Figure 4. As shown in Figure 4, the orderer information, for example, broadly includes orderer basic information, which is basic information about the orderer, and clinical trial implementation information for clinical trials that are currently being conducted or have been conducted in the past. The orderer basic information includes, for example, information such as the organization ID, organization name, address, contact information, name of the person in charge, department to which the person in charge belongs, and contact information for the person in charge. The clinical trial information includes information such as the clinical trial ID, target disease, target patient requirements, number of target patients, pharmaceutical information such as the substance name, dosage form, and administration method of the candidate drug being tested, the implementation period, the implementation facility, and responses to a questionnaire including survey items for the implementation facility.

The facility information storage unit 132 stores the facility information acquired by the facility information acquisition unit 112, an example of which is shown in Figure 5. As shown in Figure 5, the facility information, for example, broadly includes basic facility information, which is basic information about the facility, and performance information regarding the performance of clinical trials conducted in the past. The basic facility information, for example, includes information such as the facility ID, organization name, address, contact information, medical department, doctor, person in charge, department to which the person in charge belongs, contact information for the person in charge, and responses to the questionnaire. The performance information, for example, includes information such as the clinical trial ID, target disease, target patients, number of target patients, pharmaceutical information, implementation period, responsible coordinator, and attending doctor.

The clinical trial information storage unit 133 stores clinical trial information regarding planned clinical trials, an example of which is shown in Figure 6, acquired by the clinical trial information acquisition unit 113. As shown in Figure 6, the clinical trial information includes, for example, the clinical trial ID, target disease, expected target patient requirements, expected number of target patients, pharmaceutical information such as the substance name, dosage form, and administration method of the candidate drug being tested, expected implementation period, expected implementation facilities, a questionnaire including survey items for the implementation facilities, responses required for the survey items, and priority.

The questionnaire is a collection of questions that the client needs to ask potential implementation facilities before selecting them. Candidate implementation facilities prepare answers to the questionnaire items. These include the facility's policy for treating patients with the disease that is the target of the clinical trial, the expected number of such patients, whether the facility has the necessary equipment, whether and how much experience the facility has in conducting clinical trials in that field, and whether there are doctors available to handle the trials.

The response information storage unit 134 stores response information to survey form items acquired by the response information acquisition unit 115, an example of which is shown in Figure 7.

The questionnaire items stored in the clinical trial information storage unit 133 may be set to differ depending on the content of the clinical trial. Responses to the items stored in the response information storage unit 134 include, but are not limited to, selecting one or more of the presented options, entering numerical or text information, entering or selecting a date, uploading electronic files such as documents or images (including videos), etc.

The progress information storage unit 135 stores information regarding the progress of the clinical trial project acquired by the progress information acquisition unit 118.

This concludes the explanation of the data structure of server device 1.

Here, in this embodiment, the functions of the client information acquisition unit 111, implementation facility information acquisition unit 112, clinical trial information acquisition unit 113, questionnaire information presentation unit 114, response information acquisition unit 115, implementation facility selection support unit 116, contract support unit 117, progress information acquisition unit 118, progress management unit 119, billing support unit 120, implementation facility information presentation unit 121, and implementation facility candidate selection unit 122 are described.

As an example, the orderer information acquisition unit 111 presents an input form for orderer information to the orderer terminal 3 via the network 2 and acquires information about the orderer. The communication for sending and receiving may be wired or wireless, and any communication protocol may be used as long as mutual communication is possible. Note that part or all of the orderer information may be collected by the business using the server device 1 through interviews or questionnaires with the orderer, and input directly to the server device 1, or may be input from the business terminal via the network 2. The orderer information acquisition unit 111 stores the orderer information in the orderer information storage unit 131.

As an example, the implementation facility information acquisition unit 112 presents an input form for implementation facility information to the order taker terminal 4 via the network 2 and acquires information about the implementation facility. The communication for sending and receiving may be either wired or wireless, and any communication protocol may be used as long as mutual communication is possible. Note that some or all of the implementation facility information may be collected by the business using the server device 1 through interviews or questionnaires at the implementation facility and input directly into the server device 1, or may be input from the business terminal via the network 2. The implementation facility information acquisition unit 112 stores the implementation facility information in the implementation facility information storage unit 132.

As an example, the clinical trial information acquisition unit 113 presents an input form for the planned clinical trial to the client terminal 3 via the network 2 and acquires the clinical trial information. The communication for sending and receiving may be either wired or wireless, and any communication protocol may be used as long as mutual communication is possible. Note that the business using the server device 1 may collect information from the client through interviews or questionnaires, etc., and input some or all of the clinical trial information directly into the server device 1, or input it from the business terminal via the network 2. The clinical trial information acquisition unit 113 stores the clinical trial information in the clinical trial information storage unit 133.

As an example, the questionnaire information presentation unit 114 presents a response form generated based on the questionnaire information stored in the clinical trial information storage unit 133 to the order taker terminal 4 via the network 2. If questionnaire response information is stored in the orderer information storage unit 131 (if the orderer has previously responded to another questionnaire), the questionnaire information presentation unit 114 may compare the information with the questionnaire information, extract information that can be used as a response to the questionnaire response information, and present the response form to the order taker terminal 4 with the information already entered as a proposed answer. (An electronic file may be sent, or paper copies may be collected.)

The questionnaire information presentation unit 114 may present the response form to the potential implementation facility designated by the client and stored in the clinical trial information storage unit 133, or to the implementation facility selected by the candidate implementation facility selection unit 122 (described below), or to both.

If the number of response information acquired by the response information acquisition unit 115 (described below) or the number of selections acquired from the facility selection information acquired by the facility selection support unit 116 does not meet the pre-specified number of facilities, the questionnaire information presentation unit 114 may present the response form to other facility candidates.

As an example, the response information acquisition unit 115 acquires response information entered into the response form presented by the questionnaire information presentation unit 114 from the order taker terminal 4 via the network 2. The communication for sending and receiving may be either wired or wireless, and any communication protocol may be used as long as mutual communication is possible. Note that the business using the server device 1 may collect information through interviews or questionnaires with the purchaser and input some or all of the response information directly into the server device 1, or may input it from the business terminal via the network 2. The response information acquisition unit 115 stores the response information in the response information storage unit 134.

The implementation facility selection support unit 116 supports the purchaser in selecting a medical facility where the clinical trial will be conducted. The implementation facility selection support unit 116 presents the response information stored in the response information storage unit 134 and a function for accepting the selection of the implementation facility that entered the response information to the purchaser terminal 3. The function for accepting the selection may be, but is not limited to, a check box. The implementation facility selection support unit 116 may also provide a function for sending and receiving messages between the purchaser terminal 3 and the order taker terminal 4 of the implementation facility that entered the response information, for the purpose of conducting a question-and-answer session before selection. The function for sending and receiving messages may be for sending and receiving text information, image information, or audio information, or may be a function such as a voice call or online interview.

The facility selection support unit 116 may propose appropriate clinical trial facilities to the purchaser based on one or more of the purchaser information, facility information, clinical trial information, and response information. The facility selection support unit 116 may propose clinical trial facilities to the purchaser, for example, based on performance information included in the purchaser information or facility information. Specifically, if the facility selection support unit 116 receives response information from a clinical trial facility with which the purchaser has previously requested a clinical trial, or if the facility inputs response information for a purchaser with which it has previously received an order, the facility selection support unit 116 presents the facility to the purchaser. The facility selection support unit 116 may also propose facilities with a high degree of match to the purchaser, for example, based on the degree of match between the clinical trial information and the response information. Specifically, the facility selection support unit 116 may compare the responses required for each item on the questionnaire obtained from the purchaser with the response information obtained from the facility, match the text and options, and present the facility to the purchaser in descending order of the number of responses with the highest degree of overlap. If there are prioritized items among the responses required for each item on the questionnaire, the implementation facility selection support unit 116 may present the implementation facility with the highest degree of match to the client based on the degree of match between the response required by the client and the response information obtained from the implementation facility for the prioritized items.

The contract support unit 117 supports the purchaser in concluding a contract with the selected implementation facility. The contract support unit 117 accepts uploads of electronic files of draft contracts from the purchaser terminal 3 and presents them to the order taker terminal 4 for download. The contract support unit 117 may provide a message sending and receiving function that allows for questions and answers regarding the contract, or may accept uploads of revised electronic files of the draft contract from the order taker terminal 4. The contract support unit 117 accepts uploads of final electronic files of contracts agreed upon by both parties from the purchaser terminal 3 or the order taker terminal 4 and presents them to the other party for download. A function that allows for the assignment of electronic certificates and timestamps to conclude electronic contracts may also be provided. Furthermore, after the contract is concluded, the purchaser provides the implementation facility with some of the materials necessary for the clinical trial, as well as training menus for implementation, and the contract support unit 117 may provide a function that reports the arrival of these materials and the completion of training to the purchaser.

The progress information acquisition unit 118 acquires information on the implementation plan and progress in association with the clinical trial project to be conducted at the implementation facility, and stores it in the progress information storage unit 135. The progress information acquisition unit 118 acquires the protocol (clinical trial plan) for the clinical trial to be conducted at the implementation facility from the client terminal 3 or the trial facility's terminal (order taker terminal 4, clinical trial manager terminal 5, clinical trial investigator terminal 6). The progress information acquisition unit 118 provides tools for creating tasks and schedule plans, assigning and changing task personnel, and managing progress, such as Gantt charts and task lists, examples of which are shown in Figures 8, 9, and 10. The progress information acquisition unit 118 may use these tools to generate Gantt charts, task lists, etc., based on the protocol information, or the client or clinical trial investigator may use these tools to create the clinical trial plan. The progress information acquisition unit 118 may use these tools to create an entry plan based on the protocol information. When a patient visit date is set in the entry plan, the progress information acquisition unit 118 may set the visit date with a predetermined margin of days before or after the visit date. The progress information acquisition unit 118 may create KPIs, such as the number of patients who have successfully registered cases (visits), and accept input of the numerical values. Furthermore, the plan may also include important milestones in the clinical trial project (including, but not limited to, the time of clinical trial contract signing) and tasks defined in the clinical trial protocol (referred to as milestones, including, but not limited to, the timing of billing. Milestones include, but are not limited to, the time of the institutional review board meeting). Furthermore, the progress information acquisition unit 118 may generate images or information that visualize the progress of the KPIs or the progress of the plan based on the progress information, as shown in examples in FIGS. 9 and 10 , and may present the images or information to one or more of the client, order taker, clinical trial manager, clinical trial investigator, and collaborators. The progress information acquisition unit 118 acquires information related to the progress of the plan, such as KPI values and Gantt chart revisions, from the investigator terminal 6, and stores this information in the progress information storage unit 135. Note that the progress information acquisition unit 118 may also acquire information related to the progress of the plan (for example, when a patient receives or takes medication) from the information terminal (patient terminal) used by the patient participating in the clinical trial via a network by accepting input from the patient via an app or browser running on the patient terminal. The progress information acquired from these patient terminals may also be used to generate images that visualize the plan generated by the progress information acquisition unit 118, the progress of KPIs, and the progress of the plan.

The progress management unit 119 may provide request details (patient information and scheduled visit dates, medical interview and test details, etc.) and schedule reminders to collaborators who administer medication and perform tests for clinical trials at medical facilities, such as doctors, nurses, and clinical laboratory technicians. The progress management unit 119 may also provide information about hospital visit dates and medication schedules and schedule reminders to patients participating in the clinical trial. The progress management unit 119 acquires from the clinical trial investigator terminal 6 the request details for the collaborator, contact information such as email addresses, SNS, and telephone (SMS), as well as information about the start date and time and deadline date and time. The progress management unit 119 notifies the collaborator terminal 7 of the request details a specified number of days or hours, such as one week, three days, or one day, before the start date and deadline date and time. The notification may be sent by email to the email address, a message via SNS or telephone (SMS), or a pop-up on the display of the collaborator terminal 7.

The progress management unit 119 may generate and present documents related to clinical trial work (general in-hospital forms used in clinical trial work, etc.) to the collaborator. The progress management unit 119 generates an electronic in-hospital form file by fitting the protocol information and task information into frames provided in a template of the in-hospital form. The progress management unit 119 may present the generated electronic in-hospital form file to the clinical trial manager and clinical trial personnel in an editable format and accept revisions. The progress management unit 119 may output the generated electronic in-hospital form file on paper using a printer or the like, or may present it on the collaborator terminal 7. In addition, the server device 1 may store information on template in-hospital forms used at each clinical trial facility in advance, and the progress management unit 119 may generate an electronic in-hospital form file using the template received for each clinical trial facility.

As shown in an example in Figure 11, the progress management unit 119 accepts text information and image information from the order taker, clinical trial manager, clinical trial investigator, and collaborators, and shares information about progress with one or more of the order taker, clinical trial manager, clinical trial investigator, and collaborator (designation may be accepted from the person who entered the text information, or selection from a pre-created group may be accepted).

The progress management unit 119 presents information regarding the progress of the clinical trial project to the client. The progress management unit 119 presents information regarding the KPIs and progress management information regarding milestones, which is contained in the progress information storage unit 135, to the client terminal 3. For example, Figure 12 shows an example of progress information generated by the progress management unit 119 and presented to the client. This allows the client to understand the progress without obtaining personal information such as the patient's name. The progress management unit 119 may also provide a function that allows messages to be sent and received between the client and the trial personnel.

When a clinical trial project is completed, the progress management unit 119 may store the requested clinical trial information associated with the clinical trial project stored in the clinical trial information storage unit 133, and revised clinical trial information that has been revised to reflect the actual number of patients and schedule for which the requested clinical trial information was conducted, as clinical trial implementation information in the client information storage unit 131 and actual results information in the implementation facility information storage unit 132.

The billing support unit 120 supports the issuance of invoices from the implementation facility at the milestones, upon project completion, or at any other time. The billing support unit 120 obtains information regarding the timing, expense items, and amount of billing from the clinical trial manager terminal 5. The billing support unit 120 may provide a function for generating an electronic estimate file at the time of contracting, and may generate electronic files of delivery notes and invoices based on the estimate information. When the time for billing arrives (the billing support unit 120 may determine that the milestone has been achieved), the billing support unit 120 notifies the clinical trial manager terminal 5 that the time for billing has arrived. The billing support unit 120 may accept instructions from the clinical trial manager terminal 5 and output the invoice as an electronic file, or may present the invoice data to the client terminal 3.

The implementation facility information presentation unit 121 presents information about implementation facilities to the purchaser. At this time, the implementation facility information presentation unit 121 may have a function that allows the search for implementation facilities. As an example, the implementation facility information presentation unit 121 presents to the purchaser some or all of the implementation facility basic information, performance information, and response information to the questionnaire stored in the implementation facility information storage unit 132, all of which are stored in the implementation facility information storage unit 132. The implementation facility information presentation unit 121 has a function that allows the search for implementation facilities, and matches information in the implementation facility information storage unit 132 or the response information storage unit 134 based on information necessary for narrowing down the search, such as search keywords, number of performances, and patients with the target disease, received from the purchaser terminal 3, and presents the above-mentioned information about the implementation facilities that have been found to the purchaser terminal 3. At this time, the implementation facility information presentation unit 121 may present the information in order of the number of matches with the information necessary for the narrowing down, or may accept a selection of information that the purchaser considers important among the information necessary for the narrowing down, and present the information ranked based on the information considered important.

The candidate facility selection unit 122 presents the client with information on facilities that may be able to conduct the clinical trial. As an example, the candidate facility selection unit 122 can select as candidate facilities those facilities that exceed a predetermined degree of match based on the degree of match between the requested clinical trial information stored in the clinical trial information storage unit 133 and the basic facility information and performance information stored in the facility information storage unit 132. The questionnaire information presentation unit 114 may present a questionnaire to the candidate facility selected by the candidate facility selection unit 122, or the questionnaire information presentation unit 114 may present the candidate facility to the client, accept input from the client terminal 3 as to whether to present a questionnaire, and present the questionnaire based on the information on that decision. When determining the degree of match, the candidate facility selection unit 122 may also use a thesaurus or spelling variation data stored in the server device 1.

The clinical trial proposal unit 123 has a function that allows the client to revise the clinical trial plan based on the client's planned clinical trial plan and the track record of other similar clinical trials. The clinical trial proposal unit 123 determines whether the requested clinical trial information is similar to the requested clinical trial information based on some or all of the requested clinical trial information stored in the clinical trial information storage unit 133, the clinical trial implementation information stored in the client information storage unit 131, and the track record information stored in the implementation facility information storage unit 132. The clinical trial proposal unit 123 may determine that a clinical trial is similar, for example, if the target disease or implementation facility is the same. Based on the information of a clinical trial determined to be similar, the clinical trial proposal unit 123 presents a comparison screen on the client terminal 3 that allows the client to compare and edit the requested clinical trial information. This allows the client to make revisions based on the number of target patients and implementation period. Furthermore, the clinical trial proposal unit 123 may make appropriate suggestions if the client determines that the requested clinical trial information is insufficient based on the information of a clinical trial determined to be similar. As an example, the clinical trial proposal unit 123 may calculate the average value of numerical values such as the number of target patients and implementation period of clinical trials determined to be similar, and if the average value differs by more than a predetermined value from the number of target patients or implementation period included in the requested clinical trial information, it may display a warning on the comparison screen or may display the average value. The clinical trial proposal unit 123 may also obtain clinical trial information similar to the requested clinical trial information based on clinical trial information publicly available on the Internet.

A typical processing flow of this embodiment will be explained using Figure 13. The orderer information acquisition unit 111 acquires orderer information from the orderer terminal 3 (1001). The implementation facility information acquisition unit 112 acquires implementation facility information from the order-receiving terminal 4 (1002). The clinical trial information acquisition unit 113 acquires clinical trial information from the orderer terminal 3 (1003). The questionnaire information presentation unit 114 presents a questionnaire response form to the order-receiving terminal 4 (1004). The response information acquisition unit 115 acquires response information from the order-receiving terminal 4 (1005). The implementation facility selection support unit 116 presents the response information to the orderer terminal 3 and acquires selection information from the orderer terminal 3 (1006). The contract support unit 117 accepts an upload of an electronic contract draft file from the orderer terminal 3, presents it to the order-receiving terminal 4, and processes the electronic contract (1007). The progress information acquisition unit 118 acquires planning information such as tasks and schedules from the investigator terminal 6 (1008). Furthermore, the progress information acquisition unit 118 acquires information related to progress from the investigator terminal 6 (1009). The progress management unit 119 extracts information related to KPIs and milestones from the progress information acquired from the investigator terminal 6 and presents it on the orderer terminal 3 (1010).

The clinical trials disclosed herein may include clinical trials of foods such as functional foods, and investigator-initiated clinical trials (clinical research), and the implementation facilities may include universities, companies, local governments, independent administrative agencies, etc., or may be a collaboration between the implementation facility and a business that provides operational support to the implementation facility, such as an SMO.

The server device 1 may have a function to enter patients from other medical facilities (hereinafter referred to as affiliated medical facilities) affiliated with the clinical trial facility (hereinafter referred to as the primary facility). In this case, the questionnaire information presentation unit 114 presents the clinical trial information and the questionnaire information to the information terminal used by the affiliated medical facility. At this time, the questionnaire information presentation unit 114 may present the clinical trial information and the questionnaire information to the affiliated medical facility with the consent of the primary facility. The server device 1 may also accept registration of affiliated medical facilities from the primary facility. The response information acquisition unit 115 accepts input of information such as responses to the questionnaire and the number of patients eligible to enter from the affiliated medical facility, and presents this information to the primary facility for each affiliated medical facility or after tallying it. The response information acquisition unit 115 may also acquire response information to the questionnaire based on information such as responses to the questionnaire and the number of patients eligible to enter presented by the affiliated medical facility, and present this to the client. Furthermore, the contract support unit 117 may support the conclusion of a contract between a main facility and an affiliated medical facility, similar to a contract between a client and a main facility. When a main facility accepts an order for a clinical trial project that requires collaboration with an affiliated medical facility, the progress information acquisition unit 118 may, with the consent of the main facility, share with the affiliated medical facility some or all of the protocol related to the clinical trial project and schedule management functions such as Gantt charts based on the protocol. The progress information acquisition unit 118 may also acquire information contained in medical records, medical information release forms, and medical questionnaires related to patients participating in the clinical trial through referrals from the affiliated medical facility and present them to the main facility. The progress management unit 119 may also accept input such as progress reports from the affiliated medical facility. The billing support unit 120 may support billing between a main facility and an affiliated medical facility, or between an affiliated medical institution and a business operator conducting business using the server device 1, similar to billing between a client and a main facility.

The server device 1 may also have a function to acquire information such as medical records containing information on the patient's treatment and health condition from the main implementing facility or affiliated medical facilities, and compare it with questionnaire information to determine whether the patient is appropriate as a clinical trial subject. In this case, the server device 1 may compare the text information contained in a patient's medical records, etc. with the text information contained in the questionnaire, and if there is a high degree of match, determine that the patient is appropriate as a clinical trial subject, but this method is not limited to this.

The server device 1 may have the functionality required for SDV (Source Date Verification). In this case, the server device 1 acquires and stores source documents (medical records, test results, etc., including information to be analyzed in the clinical trial) created by clinical trial coordinators at the medical facility and collaborators such as doctors and laboratory technicians from the clinical trial manager terminal 5, clinical trial investigator terminal 6, collaborator terminal 7, etc. The server device 1 may control the source documents so that only purchasers who meet specified conditions can view them. Furthermore, when the purchaser views the source documents, the server device 1 stores information such as the source documents viewed, the date and time of viewing, and the name of the purchaser who viewed them (which may be an ID or account name, etc.).

The server device 1 may have an SDV reservation function. In this case, the server device 1 obtains SDV reservation information from the client terminal 3. The reservation information includes the type of source document desired to be viewed, the desired date and time, and the name of the person in charge (which may be an ID or account name, etc.). The server device 1 presents the reservation information to the trial manager terminal 5 and the trial investigator terminal 6, and may obtain response information such as approval or disapproval or a request to reconsider the schedule from the trial manager terminal 5 and the trial investigator terminal 6, and present this information to the client terminal 3. The server device 1 may also have functions such as messaging, chat, online calls, and online interviews between the client terminal 3 and the trial manager terminal 5 or the trial investigator terminal 6. The server device 1 may also obtain information on available dates for SDV from the trial manager terminal 5 and the trial investigator terminal 6, present this information to the client terminal 3, and accept selection of the date from the client terminal 3.

The server device 1 may also have the functionality of a file server that shares information between clinical trial site personnel, between the client and the clinical trial site, and between the lead site and an affiliated medical facility. The server device 1 accepts and stores electronic file uploads from the client terminal 3, the clinical trial manager terminal 5, the clinical trial staff terminal 6, the collaborator terminal 7, and information terminals used by staff at affiliated medical facilities. The server device 1 can accept permission settings for files and folders, such as viewing, editing, and downloading, from the user who uploaded the file.

The server device 1 may have a function to support the creation of work-related reports. The server device 1 stores templates for work-related reports (including, but not limited to, deviation reports, audit reports, field surveys, and business records). The server device 1 accepts a selection of the type of report to be created from the clinical trial manager terminal 5, clinical trial staff terminal 6, collaborator terminal 7, information terminal used by staff at affiliated medical facilities, etc., and presents the corresponding template to the terminal that accepted the selection. The server device 1 also stores the information items that need to be entered into the template, and accepts input or selection for those items.

For example, when the server device 1 receives a deviation report selection from the investigator terminal 6, it presents a deviation report template to the investigator terminal 6. Furthermore, the server device 1 presents a form to the investigator terminal 6 that accepts input and selection of items such as project, subject, date and time, and content, and acquires the input and selected information and inputs it into the template. Since the server device 1 recognizes the investigator, it may present a list of projects the investigator is responsible for to the investigator terminal 6 and accept the selection, or it may present a list of subjects enrolled in the selected project to the investigator terminal 6 and accept the selection. Furthermore, the server device 1 may accept selection of content contained in reports and materials stored in the progress information storage unit 135 or the file server, and input the selected content into the boxes corresponding to the template content. The server device 1 may also accept deletion or editing of information entered into the template from the investigator terminal 6. Furthermore, the server device 1 may present the created materials to the sharing or delivery destinations received from the trial investigator terminal 6.

The server device 1 may generate project data related to ongoing clinical trials and present it to terminals used by the client or clinical trial site personnel. This project data may include, for example, revenue-related data such as sales and billing timing for each project, the allocation of human resources to each project (see, for example, Figure 14), the number of projects and subjects involved in each clinical trial staff member or collaborator, the number of days required for response (see, for example, Figures 15 and 16), a summary of deviations (see, for example, Figure 17), project progress (such as the current day's trials and subject arrival times, tasks for clinical trial staff and collaborators, calendars and schedules corresponding to the week, month, and project periods, shared memos, and to-do memos entered by users of the system; see, for example, Figure 18), etc. The project data may also include details for each project (such as project management number, protocol number, client name, investigational drug, number of contracted cases, number of conducted cases, trial period, entry period, and date of initial IRB approval), as shown in Figure 19. It may also include information on a list of subjects participating in a project (see Figure 20 for an example).

The server device 1 may present the project data collectively for each client or each clinical trial facility. For example, the server device 1 may present ongoing clinical trial projects to the client terminal 3, and present the project data when a selection is received. Also, for example, the server device 1 may present ongoing clinical trial projects to the clinical trial facility, or may present the data collectively as clinical trial projects handled by each clinical trial coordinator, but the presentation method is not limited to these.

The above describes in detail preferred embodiments of the present disclosure with reference to the accompanying drawings, but the technical scope of the present disclosure is not limited to such examples. It is clear that a person with ordinary skill in the technical field of the present disclosure could conceive of various modified or altered examples within the scope of the technical ideas set forth in the claims, and it is understood that these also naturally fall within the technical scope of the present disclosure.

The devices described in this specification may be implemented as stand-alone devices, or may be implemented as multiple devices (e.g., cloud servers) partially or entirely connected via a network. For example, each functional unit and each storage unit of server device 1 may be implemented as a different server connected to each other via a network.

The series of processes performed by the devices described in this specification may be implemented using software, hardware, or a combination of software and hardware. A computer program for implementing each function of the server device 1 according to this embodiment can be created and installed on a PC or the like. A computer-readable recording medium on which such a computer program is stored can also be provided. Examples of recording media include magnetic disks, optical disks, magneto-optical disks, and flash memory. The computer program may also be distributed, for example, via a network, without using a recording medium.

Furthermore, the processes described using flowcharts in this specification do not necessarily have to be performed in the order shown. Some processing steps may be performed in parallel. Furthermore, additional processing steps may be employed, and some processing steps may be omitted.

Furthermore, the effects described in this specification are merely descriptive or exemplary and are not limiting. In other words, the technology disclosed herein may achieve other effects in addition to or in place of the above-mentioned effects that would be apparent to those skilled in the art from the description herein.

REFERENCE SIGNS LIST 1 Server device 2 Network 3 Ordering party terminal 4 Order receiving staff terminal 5 Clinical trial manager terminal 6 Clinical trial staff terminal 7 Collaborator terminal 101 Processor 102 Memory 103 Storage device 104 Communication interface 105 Input device 106 Output device 111 Ordering party information acquisition unit 112 Implementation facility information acquisition unit 113 Clinical trial information acquisition unit 114 Questionnaire information presentation unit 115 Response information acquisition unit 116 Implementation facility selection support unit 117 Contract support unit 118 Progress information acquisition unit 119 Progress management unit 120 Billing support unit 121 Implementation facility information presentation unit 122 Implementation facility candidate selection unit 123 Clinical trial proposal unit 131 Ordering party information storage unit 132 Implementation facility information storage unit 133 Clinical trial information storage unit 134 Response information storage unit 135 Progress information storage unit

Claims (8)

A clinical trial support device that supports the selection of clinical trial facilities,
a facility selection support unit that sends clinical trial information including question items necessary for selecting a facility for the clinical trial, the question items being set to vary depending on the content of the clinical trial, to the candidate facilities, obtains answers to the questions from the candidates, and presents the answers to the questions to the client;
Equipped with
The implementation facility selection support unit compares the answers requested for the question items obtained from the client with the contents of the answers to the items, presents the candidates to the client in descending order of the number of question items with a high degree of match, and obtains selection information for the candidates from the client.
Clinical trial business support equipment. The implementation facility selection support unit compares the answers requested for the question items in the prioritized question items with the contents of the answers.
The clinical trial support device according to claim 1. The question items include at least one of the following: a policy for treating patients with the disease that is the subject of the clinical trial; whether or not the facility is equipped; and whether or not there is a doctor available to treat the patient.
3. The clinical trial support device according to claim 1 or 2. When presenting the second item to the candidate regarding a second clinical trial after obtaining an answer to the first item from the candidate regarding a first clinical trial, if there is a common item between the first item and the second item, the implementation facility selection support unit presents the second item with information on the answer to the common item in the first item already input as a proposed answer to the common item in the second item.
3. The clinical trial support device according to claim 1 or 2. A contract support unit that supports the conclusion of a contract between the client and the implementation facility selected by the client;
3. The clinical trial support device according to claim 1 or 2, comprising: an implementation facility information presentation unit that presents medical facility information including the clinical trial performance of the implementation facility to the client;
The clinical trial support device according to claim 1 or 2, further comprising: A clinical trial support program that supports the selection of clinical trial sites,
The processor
a facility selection support step of sending clinical trial information including question items necessary for selecting a facility for the clinical trial, the question items being set to vary depending on the content of the clinical trial, to candidate facilities, obtaining answers to the questions from the candidates, and presenting the answers to the questions to the client;
Execute
The implementation facility selection support step compares the answers desired for the question items obtained from the client with the contents of the answers to the items, presents the candidates to the client in descending order of the number of question items with a high degree of match, and obtains selection information for the candidates from the client.
Clinical trial business support program. A clinical trial support method for supporting the selection of a clinical trial site, comprising:
The processor:
a facility selection support step of sending clinical trial information including question items necessary for selecting a facility for the clinical trial, the question items being set to vary depending on the content of the clinical trial, to candidate facilities, obtaining answers to the questions from the candidates, and presenting the answers to the questions to the client;
Run
The implementation facility selection support step compares the answers desired for the question items obtained from the client with the contents of the answers to the items, presents the candidates to the client in descending order of the number of question items with a high degree of match, and obtains selection information for the candidates from the client.
Methods for supporting clinical trial operations.