JP2022048633A - Clinical trial management support system - Google Patents

Abstract

To provide a system for improving the QOL (Quality of Life) of a patient by providing the patient with early clinical trial information about a rare disease.SOLUTION: In a clinical trial management support system, information of patient desiring consultation about a rare disease or a clinical trial, information about an institution of executing the clinical trial and information of a medical person for receiving the consultation are received. List information of the clinical trial is created on the basis of the information and is displayed in a patient terminal. Clinical trial execution institution information with application reception completed and medical person information are associated with user information and displayed on the patient terminal. Answer information to a questionnaire about the clinical trail is transmitted to medical person terminal. The propriety of the patient as a subject of the clinical trial is selected on the basis of the answer information to the questionnaire information and/or a history of messages.SELECTED DRAWING: Figure 1

Description

The present invention relates to a system that supports disease diagnosis and clinical trials.

Various disease diagnosis systems have been conventionally proposed.

Patent Document 1 proposes a disease diagnosis / treatment / prevention system for a general doctor to consult a specialist regarding a patient's symptom and treatment method for a rare disease / disease with a small number of patients.

Patent Document 2 proposes an effective method for managing a clinical trial to be performed when a patient is treated with a new investigational drug.

Japanese Unexamined Patent Publication No. 2012-177975 Japanese Patent No. 6347008

With advances in advanced medical technologies such as gene therapy and stem cell transplantation, there are increasing opportunities to provide accurate diagnosis and effective treatment of patients for diseases of unknown cause. However, in the case of a rare disease with a small number of morbidity, it is difficult for a general practitioner to make an accurate diagnosis, and therefore effective treatment may not be possible. Therefore, as described in Patent Document 1, general practitioners search for a limited number of specialists and provide patient information to the specialists, thereby providing a service for diagnosing and treating patients at an earlier stage. It's coming. Further, in the case of a rare disease, since the number of patients is small, the choice of therapeutic drug is limited, and treatment with an unapproved investigational drug is often attempted. Therefore, it is described in Patent Document 2. A system has been developed for efficient operation of clinical trial drugs. However, there are few opportunities for general practitioners to come into contact with such clinical trial information, and as a result, there is a problem that treatment of patients suffering from rare diseases is delayed due to the delay in the cooperative operation of such specialists and clinical trial coordinators. .. Therefore, by strengthening the cooperation between general practitioners and specialists in charge of rare diseases and sharing patient disease information, not only will it lead to faster diagnosis and treatment, but also information on clinical trials possessed by specialists will be shared with general practitioners. A system is desired.

Therefore, it is an object of the present invention to provide patients with earlier clinical trial information on rare diseases and to improve the QOL (Quality of Life) of patients.

[1]
Receive user information that is information about patients who wish to consult about rare diseases or clinical trials, information about clinical trial conducting institutions that is information about institutions that carry out the clinical trials, and consultations about the clinical trials from the patients. The information reception department that accepts medical staff information, which is medical staff information,
The clinical trial list information creation unit that creates the list information of the clinical trial based on the received information of the clinical trial executing agency and the medical staff information, and
In addition to displaying the created clinical trial list information on the display screen of the terminal used by the patient, screen display control is executed to accept applications for clinical trials conducted by a predetermined clinical trial executing agency from the clinical trial list information. Then, the clinical trial application reception department that sends the user information related to the application to the terminal used by the medical staff as test candidate information, and
The clinical trial executing agency information and the medical staff information related to the clinical trial for which the application has been accepted are associated with the user information and displayed on the display screen of the terminal used by the patient, and participation in the clinical trial. Clinical trial participation reception department that executes screen display control to accept applications for
The questionnaire information about the clinical trial for which the application for participation has been accepted is displayed on the display screen of the terminal used by the patient, and the screen display control for receiving the response information to the questionnaire information is executed, and the response information is displayed. Questionnaire response information reception unit to be sent to the terminal used by the medical staff in association with the test candidate information,
After the acceptance of the application for the clinical trial is completed, screen display control for sending and receiving messages regarding the rare disease and consultation regarding the clinical trial is executed between the terminal used by the patient and the terminal used by the medical staff. Candidates to be tested-Medical communication department and
After the acceptance of the application for participation in the clinical trial is completed, the subject selection unit that selects the suitability of the patient as a subject of the clinical trial based on the response information to the received questionnaire information and / or the history of the message. ,
A clinical trial management support system equipped with.

According to the present invention, it is possible to provide patients with earlier clinical trial information on rare diseases and improve the QOL (Quality of Life) of patients.

It is a figure which shows an example of the configuration of the whole system including the clinical trial management support system of this embodiment. It is a figure which shows an example of the structure of the clinical trial management support system of this embodiment. (A) It is a figure showing an example of the information stored in the storage part provided in the clinical trial management support system of this embodiment. (B) It is a figure showing an example of the structure of the clinical trial management part provided in the clinical trial management support system of this embodiment. It is a figure which shows an example of the dashboard about the information about a clinical trial displayed on the user terminal connected to the clinical trial management support system of this embodiment. It is a figure which shows an example of the clinical trial list information displayed on a user terminal. Both (a) and (b) are diagrams showing an example of a state in which information about an arbitrarily selected clinical trial from the clinical trial list information shown in FIG. 5 is displayed on a user terminal. Both (a) to (c) are diagrams showing an example of screen transition of a user terminal when applying for the clinical trial shown in FIG. It is a figure which shows an example of the list information of the applied clinical trials displayed on a user terminal. Both (a) and (b) are diagrams showing an example of a state in which information about an arbitrarily selected clinical trial from the clinical trial list information shown in FIG. 8 is displayed on a user terminal. Both (a) and (b) are diagrams showing an example of medication information and medication information in a clinical trial displayed on a user terminal. Both (a) and (b) are diagrams showing an example of questionnaire information displayed on a user terminal when applying for participation in the clinical trial shown in FIG. 9 (a). It is a figure showing an example of the history of message transmission / reception with a medical person displayed on a user terminal after applying for a clinical trial. It is a figure showing an example of the history of message transmission / reception with a medical person displayed on a user terminal after participation in a clinical trial is admitted. Both (a) to (c) are diagrams showing an example of information about a visit reservation displayed on a user terminal.

Hereinafter, an example of an embodiment of the present invention will be described with reference to the accompanying drawings. The clinical trial management support system 1 of the present embodiment is a system provided by a service provider that is composed of one or a plurality of computers and manages the implementation of clinical trials.

As shown in FIG. 1, the clinical test management support system 1 of the present embodiment is communicably connected to a user terminal 2 via a communication network 4 including an Internet communication network and a wireless communication network defined by a wireless communication standard. It is a system that accepts consultations from patients about rare diseases or clinical trials and responds to them. Further, the clinical trial management support system 1 of the present embodiment is communicably connected to the medical institution system 3 via the communication network 4.

The present embodiment includes a computer program for operating a computer as the clinical trial management support system 1 described in this embodiment.

The user terminal 2 is a terminal used by a patient suffering from a disease, particularly a rare disease, to access the clinical trial management support system 1 as a user, and has a Web browsing function such as a personal computer, a smartphone, a tablet terminal, or the like. It is a terminal in which the clinical trial management support application program according to the present embodiment is installed. Although not shown, a user terminal 2 such as a personal computer, a smartphone, or a tablet terminal has a calculation processing unit composed of a CPU or the like for processing and performing calculations of various data, and a main storage unit for storing various data such as a main memory. It is provided with an information output unit such as a liquid crystal display, an information input unit such as a touch panel, and a communication unit for transmitting and receiving various information. In the present embodiment, the "patient" may be referred to as a "test candidate" or a "subject" in each situation in which the clinical trial management support system 1 is used. Further, in the present embodiment, "rare disease" refers to a disease having a population ratio of less than 1%.

The medical institution system 3 is a system composed of one or a plurality of computers and manages medical operations including clinical trials in a medical institution. The medical institution system 3 shown in FIG. 1 is deployed in a medical institution and includes a medical institution terminal 3a such as a personal computer, a smartphone, a tablet terminal, etc. used by a medical person. Although not shown, the medical institution terminal 3a has an arithmetic processing unit configured by a CPU or the like to process and perform various data, a main storage unit for storing various data such as a main memory, and information output such as a liquid crystal display. It is equipped with a unit, an information input unit such as a touch panel, and a communication unit for transmitting and receiving various information.

In this embodiment, medical professionals include the following persons and institutions.
・ Medical personnel such as doctors, nurses, pharmacists, etc. in medical institutions in charge of patient diagnosis and treatment (including conducting clinical trials) ・ Medical clerks under the direction and supervision of medical personnel ・ SMO (Site Management Organization): Clinical Research Coordinator (CRC): Clinical Research Coordinator For this reason, the medical institution terminal 3a is a terminal used by these persons or institutions and a terminal capable of inputting / outputting electronic charts. Is included.

As shown in FIG. 2, the clinical trial management support system 1 includes an information transmission / reception unit 5, a control unit 6, a storage unit 7, and a clinical trial management unit 8. As described above, the clinical trial management support system 1 is composed of one or a plurality of computers, so that each processing unit is configured by a single server or a server corresponding to each processing unit. It can be an embodiment.

The information transmission / reception unit 5 transmits / receives information to / from the user terminal 2 or the medical institution system 3.

The control unit 6 includes an arithmetic processing unit composed of a CPU or the like to process and perform calculations of various data, and a main storage unit for storing various data such as a main memory, and each of the above-mentioned units included in the clinical test management support system 1 includes. Controls information processing by the processing unit.

The storage unit 7 is an auxiliary storage device such as an internal storage. In this embodiment, as shown in FIG. 3A, clinical trial execution institution information 9, medical staff information 10, user information 11, and message transmission / reception history information 12 are stored in the storage unit 7.

The clinical trial executing agency information 9 is information about an institution that conducts a clinical trial for a rare disease. This information is provided for each clinical trial site by name (window), type (only for consultation or for consultation and participation in clinical trials), publication date, outline, recruitment period, implementation area, participation conditions (questionnaire). It consists of information such as (including conditions that require an answer to), clinical trial content (including medication and medication information), and so on.

The medical staff information 10 is information on a medical staff who receives a consultation about a rare disease or a clinical trial from a patient. This information is composed of information such as the name, name, affiliated medical institution, etc. of the above-mentioned medical staff for each clinical trial conducting institution.

User information 11 is information about a patient who wishes to consult about a rare disease or a clinical trial. This information is for each patient user account (including patient profile, questionnaire responses to participate in clinical trials), information about submitted clinical trials, information about completed clinical trials, clinical trials. It consists of information such as status information about the patient, appointment information for visits, and the presence or absence of unread messages with medical staff.

The message transmission / reception history information 12 is history information of a message regarding a consultation regarding a rare disease and a clinical trial conducted between a test candidate or a subject and a medical professional.

As shown in FIG. 3B, the clinical trial management unit 8 has a clinical trial executing agency information reception unit 13, a medical person information reception unit 14, a user information reception unit 15, a dashboard creation unit 16, and a clinical trial list information creation unit. 17, Clinical Trial Application Reception Department 18, Clinical Trial Participation Reception Department 19, Questionnaire Response Information Reception Department 20, Test Candidate-Medical Communication Department 21, Subject Selection Department 22, Subject-Medical Communication Department 23 and Visit Reservation The list information creation unit 24 is provided.

The clinical trial execution institution information reception unit 13 receives the above-mentioned clinical trial execution institution information 9 input by the medical institution terminal 3a that has accessed the clinical trial management support system 1 and stores it in the storage unit 7.

The medical care person information reception unit 14 receives the above-mentioned medical person information 10 input by the medical institution terminal 3a that has accessed the clinical trial management support system 1 and stores it in the storage unit 7.

The user information receiving unit 15 receives the above-mentioned user information 11 input by the user terminal 2 or the medical institution terminal 3a that has accessed the clinical test management support system 1, and stores it in the storage unit 7.

The dashboard creation unit 16 is a dashboard in which the patient can access the clinical test executing agency information 9, the medical staff information 10, the user information 11, and the message transmission / reception history information 12 stored in the storage unit 7 by using the user terminal 2. Create a board. In the present embodiment, the UI as shown in FIG. 4 is displayed on the user terminal 2 in which the clinical trial management support system 1 is accessed and a predetermined login operation is performed on the home screen. This allows the user to access various information.

The clinical trial list information creation unit 17 is based on the clinical trial information 9 received by the clinical trial institution information reception unit 13 and the medical staff information 10 received by the medical staff information reception department 14, and the clinical trial information and its list. Create information.

The clinical trial application reception unit 18 displays the created clinical trial list information on the display screen of the user terminal 2, and accepts applications for clinical trials conducted by a predetermined clinical trial executing agency from the clinical trial list information. The screen display control is executed, and the user information 11 related to the application is sent to the medical institution terminal 3a as test candidate information.

In the present embodiment, when the patient selects the "clinical trial consultation counter" on the dashboard displayed on the display screen of the user terminal 2 shown in FIG. 4, the clinical trial application reception unit 18 is as shown in FIG. The clinical trial list information is displayed on the user terminal 2.

Further, when the patient selects an arbitrary clinical trial from the clinical trial list information shown in FIG. 5, the clinical trial application reception unit 18 includes clinical trial executing agency information 9 and medical staff information 10 as shown in FIG. Display the test information and the application button "Apply to this window" for accepting applications for the clinical trial on the user terminal 2.

Further, when the patient selects the application button “Apply to this window” displayed on the display screen of the user terminal 2 shown in FIG. 6 (a), the clinical trial application reception unit 18 displays (a), The screen display is changed to the clinical trial application acceptance screen as shown in b). After the acceptance of the application for the clinical trial shown in FIG. 7 (c) is completed, the clinical trial application reception unit 18 sends the user information 11 related to the application to the medical institution terminal 3a as the test candidate information.

The clinical trial participation reception unit 19 associates the clinical trial information including the clinical trial executing agency information 9 and the medical staff information 10 related to the clinical trial for which the application has been accepted with the user information 11 and displays it on the display screen of the user terminal 2. At the same time, screen display control for accepting applications for participation in the clinical trial is executed.

In the present embodiment, when the patient selects "your consultation desk" on the dashboard displayed on the display screen of the user terminal 2 shown in FIG. 4, the clinical trial participation reception unit 19 applies as shown in FIG. Display the completed clinical trial list information on the user terminal 2. Each clinical trial information in the clinical trial list information that has been applied has a structure in which the clinical trial executing agency information 9 and the medical staff information 10 related to the clinical trial for which the application has been accepted are associated with the user information 11. On the display screen of the terminal 2, the name (window) and type of the clinical trial (those that accept only consultation or those that can accept consultation and participate in the clinical trial), outline, status information about the clinical trial, visit reservation information , It is possible to grasp the presence or absence of unread messages with medical staff.

Further, when the patient selects an arbitrary clinical trial from the submitted clinical trial list information shown in FIG. 8, the clinical trial participation reception unit 19 displays the clinical trial executing agency information 9 and the medical staff information 10 as shown in FIG. The clinical trial information including the above and the participation application button "I want to participate in the clinical trial" for accepting the application for participation in the clinical trial are displayed on the user terminal 2.

In this embodiment, when the patient selects an arbitrary clinical trial from the submitted clinical trial list information shown in FIG. 8, the clinical trial participation reception unit 19 is the clinical trial executing agency as shown in FIG. 10 (a). The clinical trial information including the information 9 and the medical staff information 10 and the medication and medication information "Notes on medicine" are displayed on the user terminal 2. When the patient selects the medication and medication information "Notes on medicine", the clinical trial participation reception unit 19 shifts the screen display of the user terminal 2 to the medication and medication information in the clinical trial as shown in FIG. 10 (b). ..

The questionnaire response information reception unit 20 displays the questionnaire information about the clinical trial for which the application for participation has been accepted on the display screen of the user terminal 2, and executes the screen display control for receiving the response information to the questionnaire information. The response information is associated with the test candidate information and sent to the medical institution terminal 3a.

In the present embodiment, when the patient selects the participation application button "wish to participate in the clinical trial" displayed on the display screen of the user terminal 2 shown in FIG. 9A, the questionnaire response information reception unit 20 receives the questionnaire response information. The screen display is changed to the screen for inputting the response information to the questionnaire information for participation in the clinical trial as shown in FIG. 11 (a). After the input of the response information to the questionnaire information shown in FIG. 11B is completed, the questionnaire response information receiving unit 20 associates the response information with the test candidate information (user information 11) and sends the response information to the medical institution terminal 3a.

The subject-medical communication unit 21 displays a screen for sending and receiving a message regarding a rare disease or a consultation regarding a clinical trial between the user terminal 2 and the medical institution terminal 3a after the acceptance of the application for the clinical trial is completed. Take control.

In the present embodiment, when the patient selects an arbitrary clinical trial from the submitted clinical trial list information shown in FIG. 8, the clinical trial participation reception unit 19 displays the candidate information as shown in FIG. 9 (a). The user terminal 2 is displayed with a tab "consultation chat room" in which a message can be sent and received between the medical institution terminal 3a and the user terminal 2 that have acquired the above. When the patient selects this tab "consultation chat room", the test candidate-medical staff communication unit 21 shifts the screen display to the real-time interactive dialogue screen as shown in FIG.

On this screen, a patient who is a candidate for a test can consult with a medical professional about a rare disease or a clinical trial. If necessary, a visit appointment to a medical institution conducting a clinical trial can be input on the medical institution terminal 3a side. The history of the conversation between the two parties performed on this screen is associated with the test candidate information as the message transmission / reception history information 12 and stored in the storage unit 7.

After the acceptance of the application for participation in the clinical trial is completed, the subject selection unit 22 describes the user in the clinical trial based on the response information to the received questionnaire information and / or the message transmission / reception history information 12 stored in the storage unit 7. Select the suitability as a subject.

In the present embodiment, the response information to the questionnaire information received by the questionnaire response information reception unit 20 and the message transmission / reception history information 12 regarding the consultation regarding the rare disease or clinical trial executed by the test candidate-medical communication unit 21 are provided. Patients who have applied for participation in a clinical trial by applying the predetermined selection criteria prepared in advance are selected for their suitability as subjects of the clinical trial.

When the subject selection unit 22 selects that the patient who has applied for participation in the clinical trial is appropriate as the subject of the clinical trial, the subject selection unit 22 sends the user information 11 related to the patient to the medical staff terminal 3a as the subject information. ..

The subject-medical staff communication unit 23 has a message regarding a consultation regarding a rare disease or a clinical trial between the user terminal 2 and the medical staff terminal 3a used by the patient selected as a suitable subject for the clinical trial. Execute screen display control to send and receive.

In the present embodiment, when the patient selects an arbitrary clinical trial from the submitted clinical trial list information shown in FIG. 8, the clinical trial participation reception unit 19 acquires subject information as shown in FIG. 9 (a). The user terminal 2 is displayed with a tab "clinical trial chat room" in which messages can be sent and received between the medical institution terminal 3a and the user terminal 2. When the patient selects this tab "clinical trial chat room", the subject-medical staff communication unit 23 shifts the screen display to the real-time interactive dialogue screen as shown in FIG.

On this screen, the patient, who is the subject, can consult with the healthcare professional about a rare disease or clinical trial. If necessary, a visit appointment to a medical institution conducting a clinical trial can be input on the medical institution terminal 3a side. The history of the conversation between the two parties performed on this screen is associated with the subject information as the message transmission / reception history information 12 and stored in the storage unit 7.

The visit reservation list information creation unit 24 creates the visit reservation list information based on the visit reservation information for the clinical trial included in the user information 11. In the present embodiment, when the patient selects "visit reservation" on the dashboard displayed on the display screen of the user terminal 2 shown in FIG. 4, the visit reservation list information creation unit 24 performs clinical trials as shown in FIG. The visit reservation list information about the test is displayed on the user terminal 2.

Alternatively, the "next visit scheduled date" or the "next visit scheduled date" in which the clinical trial information including the clinical trial executing agency information 9 and the medical staff information 10 displayed by the clinical trial participation reception unit 19 shown in FIG. 10A and the confirmation of the visit appointment can be selected. When the patient selects the "next visit scheduled date" or the "reservation list" in the "reservation list", the visit reservation list information creation unit 24 transfers the visit reservation list information for the clinical trial as shown in FIG. 14 to the user terminal 2. To display.

As described above, according to the clinical trial management support system 1 of the present embodiment, the real-time patient status between the patient (test candidate) and the medical staff at the consultation stage before taking the clinical trial, and the continuous status thereof. It is possible to comprehensively manage the real-time patient status between the patient (subject) and the medical staff at the stage of conducting the clinical trial. Therefore, the number of cases where medical professionals could not share the progress after consultation was completed only for rare diseases, and the cases where patient's disease information and information on clinical trials were shared among medical professionals. Can be increased.

1 Clinical trial management support system 2 User terminal 3 Medical institution system 4 Communication network 5 Information transmission / reception unit 6 Control unit 7 Storage unit 8 Clinical trial management department 9 Clinical trial implementation institution information 10 Medical personnel information 11 User information 12 Message transmission / reception history information 13 Clinical Trial Execution Institution Information Reception Department 14 Medical Information Reception Department 15 User Information Reception Department 16 Dashboard Creation Department 17 Clinical Trial Implementation Institution List Information Creation Department 18 Clinical Trial Application Reception Department 19 Clinical Trial Participation Reception Department 20 Questionnaire Response Information Reception Department 21 Candidate-Medical Communication Department 22 Subject Selection Department 23 Subject-Medical Communication Department 24 Visit Reservation List Information Creation Department

Claims (3)

Receive user information that is information about patients who wish to consult about rare diseases or clinical trials, information about clinical trial conducting institutions that is information about institutions that carry out the clinical trials, and consultations about the clinical trials from the patients. The information reception department that accepts medical staff information, which is medical staff information,
The clinical trial list information creation unit that creates the list information of the clinical trial based on the received information of the clinical trial executing agency and the medical staff information, and
In addition to displaying the created clinical trial list information on the display screen of the terminal used by the patient, screen display control is executed to accept applications for clinical trials conducted by a predetermined clinical trial executing agency from the clinical trial list information. Then, the clinical trial application reception department that sends the user information related to the application to the terminal used by the medical staff as test candidate information, and
The clinical trial executing agency information and the medical staff information related to the clinical trial for which the application has been accepted are associated with the user information and displayed on the display screen of the terminal used by the patient, and participation in the clinical trial. The clinical trial participation reception department that executes screen display control to accept applications for
The questionnaire information about the clinical trial for which the application for participation has been accepted is displayed on the display screen of the terminal used by the patient, and the screen display control for receiving the response information to the questionnaire information is executed, and the response information is displayed. Questionnaire response information reception unit to be sent to the terminal used by the medical staff in association with the test candidate information,
After the acceptance of the application for the clinical trial is completed, screen display control for sending and receiving messages regarding the rare disease and consultation regarding the clinical trial is executed between the terminal used by the patient and the terminal used by the medical staff. Candidates to be tested-Medical communication department and
After the acceptance of the application for participation in the clinical trial is completed, the subject selection unit that selects the suitability of the patient as a subject of the clinical trial based on the response information to the received questionnaire information and / or the history of the message. ,
A clinical trial management support system equipped with. When the patient is selected as a subject of the clinical trial by the subject selection unit, the subject selection unit sends the user information related to the patient to the terminal used by the medical staff as subject information.
Further provided is a subject-medical personnel communication unit that executes screen display control for transmitting and receiving messages regarding consultation regarding the rare disease and the clinical trial between the terminal used by the patient and the terminal used by the medical staff. The clinical trial management support system according to claim 1. A computer program for operating a computer as the clinical trial management support system according to claim 1 or 2.

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