JP2015125516A - Clinical trial data administration device and clinical trial system - Google Patents

Abstract

PROBLEM TO BE SOLVED: To achieve time reduction and efficiency improvement of a clinical trial task.SOLUTION: A clinical trial data administration device 10 administers information related to a clinical trial or clinical research, including a clinical trial of a new drug, or a survey or the like using an image that are requested by a pharmaceutical company. The clinical trial data administration device 10 acquires image data photographing a target region of a patient in a clinical trial, for each of a plurality of photographing timings, from a terminal 20 of a clinical trial execution medical institution that is installed at the clinical trial execution medical institution where the clinical trial is conducted, and stores the acquired image data. Further, the clinical trial data administration device 10 acquires a determination result determined by several determining doctors on the basis of each of the image data, from a determining doctor terminal 60, and stores the acquired determination result in association with the determination object image data.

Description

  The present invention relates to a clinical trial data management apparatus and a clinical trial system.

  Conventionally, when a drug candidate is newly developed by a pharmaceutical company, a test for confirming the effect and safety as a drug for a plurality of patients is performed. Specifically, a pharmaceutical company requests clinical trials and clinical research including clinical trials and investigations using images (hereinafter referred to as “clinical trials” for convenience) to clinical trial institutions such as hospitals. The institution will give medication and treatment to patients (subjects) who will cooperate in the clinical trial. In the case of a clinical trial using medical images, a site to be studied is photographed by CT (Computed Tomography), CR (Computed Radiography), MRI (Magnetic Resonance Imaging), etc., and the photographed image is written on a recording medium. The person in charge of the pharmaceutical company sends or sends the recording media on which the judgment image is written to the clinical trial medical institution, collects the image data, checks the image quality and imaging conditions, and then sends the image data to the PACS. Register (Picture Archiving and Communication System) or output to film. Then, a judgment meeting is held at a venue such as a hotel, and judgment work by a plurality of doctors is performed. The pharmaceutical company performs analysis based on the determination result, confirms the effect and safety of the new drug, and makes a regulatory application based on the result.

  For example, RECIST (Response Evaluation Criteria in Solid Tumors) determination is used for drug efficacy determination for solid cancer. A device has been proposed that calculates the longest diameter of the slice cross section of the target lesion specified in the image data obtained by imaging before the drug administration (baseline) and multiple times after drug administration, and calculates the RECIST determination result. (See Patent Document 1).

  In addition, from the viewpoint of protecting patient privacy, the patient data transferred from the facility processing device is anonymous for each patient in the central processing device connected to the facility processing devices installed in a plurality of medical facilities via a communication network. A system has been developed for statistical processing (see Patent Document 2).

JP 2010-35634 A Japanese Patent No. 4011570

However, in the clinical trial work involving the image determination as described above, it takes time and effort to collect the captured images from the clinical trial institution. Furthermore, when the collected image is incomplete, it is necessary to acquire the image again.
In addition, after collecting images, it is necessary to gather judging doctors and hold an image judging party, and it is difficult to adjust a plurality of doctors.

  The present invention has been made in view of the above problems in the prior art, and it is an object of the present invention to reduce the time and improve the efficiency of clinical trial work.

  In order to solve the above problems, the invention described in claim 1 is a clinical trial medical institution terminal installed in a clinical trial medical institution conducting a clinical trial of a new drug, and a determination for determining the effect and safety of the new drug. A clinical trial data management apparatus connected to a judgment medical terminal used by a doctor so as to be able to perform data communication via a network, wherein image data obtained by imaging a target part of a patient in the clinical trial is transmitted from the clinical trial institution terminal to the network. An image data acquisition unit that stores the acquired image data in a storage unit, and a determination result determined by the determination physician based on the image data stored in the storage unit Determination via the network and storing the acquired determination result in the storage unit in association with the determination target image data It includes a fruit obtaining means.

  According to a second aspect of the present invention, in the clinical trial data management apparatus according to the first aspect, the image data acquisition means is based on incidental information attached to the image data acquired from the clinical trial institution terminal. When it is determined whether the image data is suitable for image determination, and when it is determined that the acquired image data is suitable for image determination, the image data is stored in the storage unit. If it is determined that the acquired image data is not suitable for image determination, a request for retransmission of image data is transmitted to the trial medical institution terminal.

  According to a third aspect of the present invention, in the clinical trial data management apparatus according to the second aspect, the image data acquisition means has predetermined imaging conditions included in incidental information attached to the acquired image data. The acquired image data is determined based on whether or not personal information has been deleted in the incidental information attached to the acquired image data. It is determined whether or not it is suitable.

  The invention described in claim 4 relates to the clinical trial data management apparatus according to any one of claims 1 to 3, wherein the clinical trial data stored in the storage means is stored for each clinical trial after completion of the clinical trial. Storage control means for prohibiting the change of information is provided.

  According to a fifth aspect of the present invention, in the clinical trial data management device according to the fourth aspect, the storage control unit is configured to store the predetermined time period after the trial is over for each trial, The information related to the clinical trial stored in the storage means is deleted.

  The invention according to claim 6 is the clinical trial data management apparatus according to any one of claims 1 to 5, wherein a registration unit that registers a plurality of judgment doctor candidates and specialized fields in association with each other in advance, and the registration An extracting unit that extracts candidate doctors corresponding to the specialized field related to the clinical trial from the plurality of candidate doctors, and a doctor who actually requests determination from the extracted candidate doctors And a determination requesting means for transmitting a determination request to the determining doctor terminal corresponding to the selected determining doctor.

  The invention according to claim 7 is the clinical trial data management device according to any one of claims 1 to 6, wherein the pharmaceutical company terminal installed in the pharmaceutical company requesting the clinical trial of the new drug and the network via the network It is connected so that data communication is possible, and comprises a providing means for providing the pharmaceutical company terminal with the acquisition status of the image data and / or the acquisition status of the determination result.

  The invention described in claim 8 is a clinical trial data management device for managing information related to a clinical trial of a new drug, a clinical trial medical institution terminal installed in a clinical trial medical institution performing the clinical trial, and the effect and safety of the new drug. A clinical trial system in which a judgment physician terminal used by a judgment physician who judges the medical examination is connected to be able to perform data communication via a network, wherein the clinical trial data management device captures an image of a target region of a patient in the trial Data is acquired from the trial medical institution terminal via the network, the image data acquisition means for storing the acquired image data in the storage means, and the judgment doctor based on the image data stored in the storage means The determination result determined by is acquired from the determination medical terminal via the network, and the acquired determination result is the image of the determination target And a judgment result obtaining means to be stored in the storage means in association with over data.

  According to the present invention, it is possible to shorten the time for clinical trial work by improving the efficiency of collecting image data and determining the effect.

It is a system configuration figure of a clinical trial system in an embodiment of the invention. It is a block diagram which shows the functional structure of a clinical trial data management apparatus. It is a figure which shows the example of a part of trail DB. It is a block diagram which shows the functional structure of a clinical trial implementation medical institution terminal. It is a block diagram which shows the functional structure of a pharmaceutical company terminal. It is a block diagram which shows the functional structure of a determination medical terminal. It is a ladder chart which shows the process performed by each apparatus of a clinical trial system. It is a ladder chart which shows the process performed by each apparatus of a clinical trial system. It is a ladder chart which shows the process performed by each apparatus of a clinical trial system. It is a ladder chart which shows the process performed by each apparatus of a clinical trial system. It is a figure which shows the example of a comprehensive effect determination result.

  Hereinafter, an embodiment of a clinical trial system according to the present invention will be described with reference to the drawings. However, the scope of the invention is not limited to the illustrated examples.

[Composition of clinical trial system]
FIG. 1 shows a system configuration of a clinical trial system 100 in the present embodiment.
As shown in FIG. 1, the clinical trial system 100 includes a clinical trial data management apparatus 10 installed in a clinical trial contracting organization, a clinical trial implementation medical institution terminal 20, a PACS 30 and a modality installed in a clinical trial implementation medical institution conducting a trial of a new drug. 40, a pharmaceutical company terminal 50 installed in the pharmaceutical company, and a plurality of judgment doctor terminals 60 used by a plurality of judgment doctors that judge the effect and safety of the new drug. The “clinical trial” in this specification includes clinical trials and clinical research including clinical trials of new drugs, research using images, and the like for convenience of explanation. The clinical trial data management apparatus 10, the clinical trial institution terminal 20, the pharmaceutical company terminal 50, and the judgment medical terminal 60 are connected to be able to perform data communication via a communication network N1 such as the Internet. In FIG. 1, one clinical trial medical institution is illustrated, but actually there are a plurality of clinical trial medical institutions.

  The clinical trial data management apparatus 10 accumulates and manages information related to clinical trials requested by pharmaceutical companies. The clinical trial data management apparatus 10 transmits the clinical trial conditions to the clinical trial medical institution terminal 20 and receives image data obtained by photographing the target region of the patient before and after the medication from the clinical trial implementation medical institution terminal 20. The clinical trial data management apparatus 10 transmits an image data determination request to the determining doctor terminal 60 and receives the determination result determined by the determining doctor from the determining doctor terminal 60.

  The clinical trial medical institution terminal 20, the PACS 30, and the modality 40 are configured to be mutually communicable via an in-facility network N2 such as a LAN (Local Area Network).

  The clinical trial institution terminal 20 transmits the imaging conditions included in the clinical trial conditions received from the clinical trial data management apparatus 10 to the modality 40. The clinical trial institution terminal 20 transmits the image data of the medical image generated by the modality 40 to the clinical trial data management apparatus 10.

  The PACS 30 stores medical image image data and the like generated by the various modalities 40, and provides medical image image data and the like in response to a request from an external device.

  The modality 40 captures an image of the patient's determination target region based on the imaging conditions transmitted from the clinical trial medical institution terminal 20, and digitally converts the captured image to generate image data of a medical image. The modality 40 is configured by, for example, CT, CR, MRI, and the like. The modality 40 appends incidental information to the medical image by writing incidental information such as patient information and imaging information in the header of the image file of the medical image in accordance with the DICOM (Digital Imaging and Communications in Medicine) standard.

  The pharmaceutical company terminal 50 is a computer device used by a pharmaceutical company person requesting a clinical trial. The pharmaceutical company terminal 50 is used when requesting a clinical trial instruction or the like from the clinical trial data management apparatus 10 or confirming the progress of each clinical trial.

  The judging doctor terminal 60 receives the image data judgment request from the clinical trial data management apparatus 10 and transmits the judgment result to the clinical trial data management apparatus 10.

FIG. 2 shows a functional configuration of the clinical trial data management apparatus 10.
As shown in FIG. 2, the clinical trial data management apparatus 10 includes a control unit 11, an operation unit 12, a display unit 13, a communication unit 14, a ROM (Read Only Memory) 15, a RAM (Random Access Memory) 16, a storage unit 17, and the like. Each part is connected by a bus 18.

  The control unit 11 is composed of a CPU (Central Processing Unit) and the like, and comprehensively controls the processing operation of each unit of the clinical trial data management apparatus 10. Specifically, the CPU reads various processing programs stored in the ROM 15 in accordance with an operation signal input from the operation unit 12 or an instruction signal received by the communication unit 14, expands the program in the RAM 16, and executes the program. Various processes are performed in cooperation with

  The operation unit 12 includes a keyboard having cursor keys, numeric input keys, various function keys, and the like, and a pointing device such as a mouse. The control unit 11 receives operation signals input by keyboard operations or mouse operations. Output to. For example, the operation unit 12 is used when selecting a judgment doctor who actually requests a judgment from candidate judgment doctors extracted according to a specialized field.

  The display unit 13 includes a monitor such as an LCD (Liquid Crystal Display), and displays various screens according to instructions of a display signal input from the control unit 11.

  The communication unit 14 includes a network interface and the like, and transmits and receives data to and from an external device connected via the communication network N1.

  The ROM 15 is configured by a nonvolatile semiconductor memory or the like, and stores a control program, parameters and files necessary for executing the program, and the like. For example, the ROM 15 has a function as a Web server for providing various Web screens to the Web browser by communicating with the Web browser installed in the clinical trial medical institution terminal 20, the pharmaceutical company terminal 50, and the judging doctor terminal 60 using the HTTP protocol. A web server program for realizing the above, an application program that runs on the web server, and provides an online clinical trial service to the operator of each apparatus via a web browser are stored.

  The RAM 16 forms a work area that temporarily stores various programs, input or output data, parameters, and the like read from the ROM 15 in various processes that are executed and controlled by the control unit 11. For example, the RAM 16 temporarily stores image data received from the clinical trial medical institution terminal 20.

  The storage unit 17 is configured by an HDD (Hard Disk Drive), a semiconductor nonvolatile memory, or the like, and stores various data. For example, the storage unit 17 stores a trail DB (DataBase) 171, an image DB 172, and a judgment doctor candidate correspondence table 173.

The trail DB 171 is a database for storing data related to the clinical trial for each clinical trial.
The trail DB 171 includes, for each clinical trial, a clinical trial requester, a clinical trial drug, a lesion name, case information, clinical trial conditions, clinical trial institution information, masking information, and the like.

The clinical trial requester is an organization requesting a clinical trial such as a pharmaceutical company.
The investigational drug is the drug that is the subject of the trial. In the case of a clinical trial for a medical device, the investigational drug is the name of the medical device or device to be studied such as a stent.
The lesion name is the name of the lesion to be treated in the clinical trial.
Case information is information relating to a case that is a target of a new drug.
The clinical trial conditions are information indicating the clinical trial conditions, and include dosage, timing of medication / imaging, imaging device information, imaging conditions (imaging site, imaging direction, slice thickness, etc.) and the like.
The clinical trial institution information is information on a medical facility (hospital) where the clinical trial is conducted.
The masking information includes items (patient name, birthday, etc.) to be masked in the image data used for the determination of the clinical trial. Normally, personal information such as patient information that can identify the patient is deleted from the incidental information of the image data, but for items determined to be relevant for each trial, such as patient age, height, and weight, Removed from deletion.

In addition, in the trail DB 171, for each trial, for each of a plurality of patients, information indicating image data obtained by imaging the target region of the patient at a plurality of timings, determination results determined by the determining doctor based on the image data, and the like Are stored in association with information indicating the timing at which the image data was captured.
In the clinical trial data management apparatus 10, personal information that can identify a patient is concealed, and a patient who is a subject is managed by a clinical trial ID. The clinical trial ID is identification information assigned to each subject in order to anonymize the subject in the clinical trial. The clinical trial ID used in the clinical trial is notified from the clinical trial data management apparatus 10 to the clinical trial medical institution terminal 20.

  FIG. 3 shows an example of a part of the trail DB 171. As shown in FIG. 3, in the trail DB 171, for each of a plurality of patients (trial IDs), an imaging date, imaging timing, a sender, a transmission date and time, the number of images, a QC (Quality Control) confirmation result, a file Paths and determination results are associated with each other.

The shooting date is the date when the image was shot.
The imaging timing is information indicating the timing at which image data was captured, such as before medication, first time after medication, second time after medication, third time after medication, and so on.
The sender is information (name, user ID, etc.) indicating the person who sent the image data from the trial medical institution terminal 20.
The transmission date and time is the date and time when the image data is transmitted from the clinical trial institution terminal 20.
The number of images is the number of image data transmitted from the clinical trial medical institution terminal 20.

The QC confirmation result is information indicating whether or not the image data is suitable for image determination. For example, “1” is stored when the image data is suitable for image determination, and “0” is stored when the image data is not suitable for image determination.
The file path is information indicating a storage location of image data in the image DB 172.

In the determination result, the determination result of each determination doctor is stored for each of the plurality of determination doctors. The determination result includes information indicating the effect and safety of the investigational drug determined from the image data, and includes, for example, information indicating the longest diameter (measurement data) of the target lesion in the image and the degree of the effect. When there are a plurality of target lesions in the image, numbers are assigned to the target lesions, and changes for each imaging are described as numerical values for each target lesion.
The image data and the determination result are associated with each other through the file path of the trail DB 171.

  Note that the image data is stored in the image DB 172 only when the image data is suitable for image determination. Therefore, when the image data is not suitable for image determination (when the QC confirmation result is “0”). The file path and determination result fields are blank. When image data is retransmitted from the clinical trial institution terminal 20, it is registered as another record in the trail DB 171. In other words, even with respect to image data that has not been used for image determination, there is a history that it is determined that the image data is not suitable for image determination as a result of when it was transmitted from the clinical trial medical institution terminal 20 and QC confirmation was performed. .

  The image DB 172 stores image data of a plurality of medical images.

  The judgment doctor candidate correspondence table 173 is a table in which a plurality of judgment doctor candidates and specialized fields (parts, lesions, interpretable cases, etc.) are associated with each other and registered in advance. That is, the judgment doctor candidate correspondence table 173 functions as a registration unit. Candidate doctor candidates are radiologists who are interested in determination, and only doctors who can agree to the rules in the clinical trial system 100 are registered. In addition, since the judging doctor candidate is required to understand the ministerial ordinance and duties unique to the clinical trial, it is preferable that education for the judging doctor candidate is carried out regularly.

  The control unit 11 acquires image data obtained by imaging the target region of the patient at a plurality of timings in the clinical trial from the clinical trial medical institution terminal 20 via the communication network N1, and the acquired image data is captured by the image data. The information is stored in the storage unit 17 (the trail DB 171 and the image DB 172) in association with the information indicating the timing. That is, the control unit 11 functions as an image data acquisition unit.

  At this time, the control unit 11 determines whether the image data is suitable for image determination based on incidental information (header information) attached to the image data acquired from the clinical trial institution terminal 20. Judging. For example, the control unit 11 is attached to the acquired image data whether or not the shooting condition included in the accompanying information attached to the acquired image data matches a predetermined shooting condition. It is determined whether or not the acquired image data is suitable for image determination based on whether or not personal information has been deleted from the accompanying information. When the control unit 11 determines that the acquired image data is suitable for image determination, the control unit 11 stores the image data in the storage unit 17 (image DB 172), and the acquired image data is an image. If it is determined that it is not suitable for determination, a request for retransmission of image data is transmitted to the clinical trial medical institution terminal 20.

  The control unit 11 acquires the determination result determined by the determining doctor based on the image data stored in the storage unit 17 from the determining medical terminal 60 via the communication network N1, and uses the acquired determination result as the determination target. Are stored in the storage unit 17 (the trail DB 171 and the image DB 172) in association with the image data. That is, the control unit 11 functions as a determination result acquisition unit.

  For each clinical trial, the control unit 11 prohibits the change of the information related to the clinical trial stored in the storage unit 17 for a predetermined period after the clinical trial ends. That is, the control unit 11 functions as a storage control unit. The information related to the clinical trial includes information associated with the target clinical trial in the trail DB 171 and the image DB 172. For each clinical trial, the control unit 11 deletes information related to the clinical trial stored in the storage unit 17 after a predetermined period has elapsed since the clinical trial ended.

The control unit 11 extracts a judgment doctor candidate corresponding to a specialized field related to each clinical trial from a plurality of judgment doctor candidates registered in the judgment doctor candidate correspondence table 173 of the storage unit 17. That is, the control unit 11 functions as an extraction unit.
The control unit 11 transmits a determination request to the determining doctor terminal 60 corresponding to the determining doctor selected by the operation from the operation unit 12 among the extracted determining doctor candidates. That is, the control unit 11 functions as a determination request unit.

  The control unit 11 provides the pharmaceutical company terminal 50 with the acquisition status of the image data and the acquisition status of the determination result for each of a plurality of timings in the clinical trial. That is, the control unit 11 functions as a providing unit.

FIG. 4 shows a functional configuration of the clinical trial institution terminal 20.
As shown in FIG. 4, the clinical trial medical institution terminal 20 includes a control unit 21, an operation unit 22, a display unit 23, a communication unit 24, a ROM 25, a RAM 26, a storage unit 27, and the like. 28 is connected.

  The control unit 21, the operation unit 22, the display unit 23, the communication unit 24, and the RAM 26 have the same configuration as the control unit 11, the operation unit 12, the display unit 13, the communication unit 14, and the RAM 16 of the clinical trial data management apparatus 10, and are described. In order to avoid duplication, different configurations will be mainly described.

  The ROM 25 is composed of a nonvolatile semiconductor memory or the like, and stores a control program, parameters and files necessary for executing the program, and the like. For example, the ROM 25 stores a web browser program for realizing a web browser.

  The storage unit 27 is configured by an HDD, a semiconductor nonvolatile memory, or the like, and stores various data. The storage unit 27 stores clinical trial conditions 271, masking information 272, a patient ID correspondence table 273, and transmission history information 274 for each clinical trial.

The clinical trial condition 271 is information received from the clinical trial data management apparatus 10 and includes clinical trial protocol information such as a dosage in the relevant clinical trial, timing of medication / imaging, imaging apparatus information, imaging conditions, and the like. The clinical trial is conducted based on the clinical trial condition 271 in the clinical trial implementation medical institution.
The masking information 272 is information received from the clinical trial data management apparatus 10, and when the image data is transmitted from the clinical trial medical institution terminal 20 to the clinical trial data management apparatus 10 in the corresponding clinical trial, the masking information 272 is masked from the additional information of the image data. Contains items to be processed.
The patient ID correspondence table 273 includes, in each trial, a patient ID (patient identification information) of the patient in the clinical trial medical institution, and a trial ID (subject identification information) for distinguishing individual patients while anonymizing the patient in the trial. , Are associated with each other.
The transmission history information 274 is information in which an imaging date, an imaging timing, a sender, a transmission date and time, the number of images, and the like are associated with each of a plurality of patients (trial IDs) in the corresponding clinical trial.

  When transmitting the image data to the clinical trial data management apparatus 10, the control unit 21 uses the patient ID included in the incidental information attached to the image data as the clinical trial ID based on the patient ID correspondence table 273 of the clinical trial to be processed. At the same time, based on the masking information 272 of the target clinical trial, the contents of a predetermined item (the item to be masked included in the masking information 272) out of the incidental information attached to the image data are deleted.

FIG. 5 shows a functional configuration of the pharmaceutical company terminal 50.
As shown in FIG. 5, the pharmaceutical company terminal 50 includes a control unit 51, an operation unit 52, a display unit 53, a communication unit 54, a ROM 55, a RAM 56, a storage unit 57, and the like. It is connected.

  The control unit 51, the operation unit 52, the display unit 53, the communication unit 54, and the RAM 56 have the same configuration as the control unit 11, operation unit 12, display unit 13, communication unit 14, and RAM 16 of the clinical trial data management apparatus 10. In order to avoid duplication, different configurations will be mainly described.

  The ROM 55 is configured by a nonvolatile semiconductor memory or the like, and stores a control program, parameters and files necessary for executing the program, and the like. For example, the ROM 55 stores a web browser program and the like for realizing a web browser.

  The storage unit 57 is configured by an HDD, a semiconductor nonvolatile memory, or the like, and stores various data.

The control unit 51 transmits trial implementation information to the clinical trial data management apparatus 10 via the communication network N1, and requests a clinical trial.
The control unit 51 acquires the acquisition status of image data and the acquisition status of determination results for each of a plurality of timings from the clinical trial data management apparatus 10 via the communication network N1, and displays them on the display unit 53.

In FIG. 6, the functional structure of the judgment doctor terminal 60 is shown.
As shown in FIG. 6, the determination medical terminal 60 includes a control unit 61, an operation unit 62, a display unit 63, a communication unit 64, a ROM 65, a RAM 66, a storage unit 67, and the like. It is connected.

  The control unit 61, the operation unit 62, the display unit 63, the communication unit 64, and the RAM 66 have the same configuration as the control unit 11, operation unit 12, display unit 13, communication unit 14, and RAM 16 of the clinical trial data management apparatus 10. In order to avoid duplication, different configurations will be mainly described.

  The ROM 65 is configured by a nonvolatile semiconductor memory or the like, and stores a control program, parameters and files necessary for executing the program, and the like. For example, the ROM 65 stores a web browser program and the like for realizing a web browser.

  The storage unit 67 is configured by an HDD, a semiconductor nonvolatile memory, or the like, and stores various data.

When receiving a determination request from the clinical trial data management apparatus 10, the control unit 61 accesses the clinical trial data management apparatus 10 via the communication network N <b> 1 and displays a captured image on the display unit 63 based on the determination target image data. Display.
The control unit 61 transmits the determination result created by the determining doctor to the clinical trial data management apparatus 10 via the communication network N1.

[Operation in clinical trial system]
Next, the operation in the clinical trial system 100 will be described.
7 to 10 are ladder charts showing processes executed by each device of the clinical trial system 100. FIG. The processing in the clinical trial data management apparatus 10 is realized by software processing in cooperation with the control unit 11 and a program stored in the ROM 15, and the processing in the clinical trial medical institution terminal 20 is stored in the control unit 21 and the ROM 25. The process in the pharmaceutical company terminal 50 is realized by the software process in cooperation with the control unit 51 and the program stored in the ROM 55, and the process in the judgment medical terminal 60 is This is realized by software processing through cooperation between the control unit 61 and a program stored in the ROM 65.

  When accessing the clinical trial data management apparatus 10 in each of the clinical trial institution terminal 20, the pharmaceutical company terminal 50, and the judgment doctor terminal 60, a predetermined URL (Uniform Resource Locator) is input from the Web browser, and the clinical trial is performed. The data management device 10 provides display data for displaying a login screen to each device. The display data for various Web screens including a login screen includes HTML, style sheets, image data, scripts for causing each device to execute predetermined processing, and the like.

  In the clinical trial data management apparatus 10, user authentication is performed based on the user ID and password input from the login screen in each apparatus. Specifically, it is determined that the user authentication is OK when the input combination of the user ID and password matches the previously registered combination of user ID and password.

  First, in the pharmaceutical company terminal 50, based on the operation from the operation unit 52, the control unit 51 transmits the trial medical institution candidate list and the clinical trial condition to the clinical trial data management apparatus 10 via the communication unit 54 (step). S1). The clinical trial institution candidate list is a list of trial medical institutions that handle target cases.

In the clinical trial data management apparatus 10, the trial medical institution candidate list and the clinical trial conditions are received by the communication unit 14, and the clinical trial institution included in the trial medical institution candidate list is investigated by the control unit 11 (step S2). ). Specifically, the control unit 11 has an imaging apparatus that satisfies the clinical trial condition in the clinical trial medical institution for the clinical trial medical institution terminal 20 of the clinical trial medical institution included in the trial medical institution candidate list, Further, an inquiry as to whether or not it can be used continuously during the trial period is transmitted via the communication unit 14.
In addition, the clinical trial person in charge of the clinical trial contracting organization may inquire of the clinical trial medical institution whether the clinical trial can be conducted by telephone or FAX.

  In the clinical trial medical institution terminal 20, in response to an inquiry from the clinical trial data management device 10, the control unit 21 transmits the clinical trial medical institution information in its own facility to the clinical trial data management device 10 via the communication unit 24 ( Step S3). The information on the clinical trial site includes the name of the facility, the person in charge, contact information, imaging device information (specifications, repair / replacement schedule, etc.) and the like.

In the clinical trial data management apparatus 10, the trial medical institution information is received from the trial medical institution terminal 20 by the communication unit 14, and the clinical trial institution information is stored in the storage unit 17 by the control unit 11.
The clinical trial institution information may be input from the operation unit 12 of the clinical trial data management apparatus 10 based on information obtained from the clinical trial implementation medical institution.

  Next, the control unit 11 determines whether or not the clinical trial can be performed in the clinical trial medical institution in which the clinical trial medical institution terminal 20 is installed, based on the clinical trial implementation medical institution information. For example, based on information such as whether or not a CT that can be imaged with a slice thickness of 5 mm is held, and whether or not the CT apparatus is scheduled to be changed during the trial period, the trial medical institution is suitable for the trial. It is determined whether or not. And the control part 11 transmits a suitability determination report to the pharmaceutical company terminal 50 via the communication part 14 (step S4).

  In the pharmaceutical company terminal 50, based on the suitability determination report transmitted from the clinical trial data management apparatus 10, the clinical trial medical institution that conducts the clinical trial is determined. The decided investigational medical institution carries the investigational drug from a pharmaceutical company.

  Next, in the pharmaceutical company terminal 50, based on the operation from the operation unit 52, the control unit 51 transmits the clinical trial implementation information of the target clinical trial to the clinical trial data management apparatus 10 through the communication unit 54 (step). S5). Trial information includes the clinical trial protocol and related information describing the sponsor, clinical trial and control drug, clinical trial purpose, clinical trial summary, lesion name, case information, clinical trial conditions, clinical trial institution information, number of subjects, etc. Documentation is included.

  In the clinical trial data management apparatus 10, when clinical trial information is received by the communication unit 14, the clinical trial information is registered in the trail DB 171 of the storage unit 17 by the control unit 11 as a new clinical trial. Further, the control unit 11 determines a plurality of clinical trial IDs assigned to the subjects based on the number of subjects. Further, the control unit 11 determines items to be masked from the supplementary information of the image data based on the clinical trial implementation information, generates masking information, and stores the generated masking information in the trail DB 171 in association with the clinical trial. Is done. The items to be masked may be automatically determined based on the contents of the trial, or may be designated by an operation from the operation unit 12 of the operator of the trial data management apparatus 10.

  Next, in the clinical trial data management apparatus 10, the clinical trial condition, clinical trial ID, and masking information of the newly registered clinical trial are transmitted from the control unit 11 to the clinical trial medical institution terminal 20 through the communication unit 14 (step S6). ).

  In the trial medical institution terminal 20, the trial condition, trial ID, and masking information are received from the trial data management apparatus 10 by the communication unit 24. The control unit 21 stores the received clinical trial condition and masking information in the storage unit 27 as the clinical trial condition 271 and the masking information 272 corresponding to the new clinical trial. In addition, based on the received clinical trial ID, the control unit 21 creates a patient ID correspondence table 273 that associates the patient ID of the subject in the clinical trial medical institution with the clinical trial ID for the target clinical trial.

  In the clinical trial data management apparatus 10, the control unit 11 refers to the decision physician candidate correspondence table 173 stored in the storage unit 17, and based on the lesion name, case information, and the like included in the clinical trial implementation information, From the judgment doctor candidates, judgment doctor candidates corresponding to the specialized field related to the current clinical trial are extracted. The extracted judgment doctor candidates are displayed on the display unit 13 by the control unit 11. Then, by the operation of the operator of the clinical trial data management apparatus 10 from the operation unit 12, the judgment doctor who actually requests the judgment is selected from the extracted judgment doctor candidates, and the judgment doctor is determined (step S7). . For each clinical trial doctor who has been determined, cooperation with the clinical trial is consulted for each clinical trial by e-mail, telephone, direct visit, etc., and the doctor is determined when an agreement is obtained.

  Next, moving to FIG. 8, in the modality 40 of the clinical trial medical institution where the clinical trial medical institution terminal 20 is installed, an image of the target site of each subject before medication is taken (baseline). In the clinical trial medical institution terminal 20, the control unit 21 controls the patient in the clinical trial medical institution included in the incidental information of the image data of the medical image generated by the modality 40 based on the patient ID correspondence table 273 of the corresponding trial. The ID is replaced with the clinical trial ID, and the personal information is deleted from the incidental information of the image data based on the masking information 272 of the corresponding clinical trial. Then, the personal information is deleted by the control unit 21 and the image data with the clinical trial ID attached is transmitted to the clinical trial data management apparatus 10 via the communication unit 24 (step S8). Further, the control unit 21 transmits information indicating the photographing timing, photographing date, sender, transmission date and number of images, etc. to the clinical trial data management apparatus 10 together with the image data or as supplementary information attached to the image data. The Further, the control unit 21 records, for each trial ID (patient), the shooting date, the shooting timing, the sender, the transmission date and time, the number of images, and the like for each trial ID (patient) in the transmission history information 274.

  In the clinical trial data management apparatus 10, when information such as image data is received from the trial medical institution terminal 20 by the communication unit 14, the received image data is temporarily stored in the RAM 16 by the control unit 11. Information regarding the image data is registered in the trail DB 171. Specifically, in the trail DB 171, the imaging date, the sender, the transmission date and time, the number of images, and the like are stored in association with the corresponding imaging timing of the corresponding patient (trial ID) in the corresponding clinical trial.

  Next, the controller 11 checks whether or not the image data is suitable for image determination (step S9). Specifically, the control unit 11 determines whether or not the imaging conditions included in the incidental information attached to the image data match the imaging conditions corresponding to the corresponding clinical trial stored in the trail DB 171. In the incidental information attached to, whether the personal information corresponding to the item included in the masking information corresponding to the relevant trial stored in the trail DB 171 has been deleted, whether the imaging region is available, etc. Based on the above, it is determined whether or not the image data is suitable for image determination. For example, it is confirmed whether information described in a specific tag of DICOM image data is within a specified range. It is confirmed whether the slice thickness of CT (contents described in the tag No (0018, 0050)) is 5 mm or less, whether the shooting date is within a specified period from the previous shooting date, and the like.

  Note that items that are automatically determined based on the incidental information of the image data may be divided from items that are determined by the operator of the clinical trial data management apparatus 10. For example, the operator may determine whether personal information is masked or whether all necessary images are available. Regarding the items determined by the operator, it is determined that the image data is suitable for image determination by accepting an operation instruction for approving the confirmation of the image from the operation unit 12.

  If the image data is not suitable for image determination (step S10; NO), the controller 11 determines that the image data is not suitable for image determination, and sends a request for retransmission of the image data to the communication unit 14. Is transmitted to the clinical trial implementation medical institution terminal 20 (step S11). The image data retransmission request may be notified by e-mail or telephone. If the image data is not suitable for image determination, the control unit 11 stores “0” in the QC confirmation result of the image data in the trail DB 171 and erases the image data from the RAM 16. .

If it is determined that the image data is not suitable for image determination because the content of the masked item specified in the masking information is not deleted, the control unit 21 in the clinical trial medical institution terminal 20 Based on the masking information 272 of the relevant trial, the personal information is deleted from the target image data, and the image data after the personal information is deleted is retransmitted to the clinical trial data management apparatus 10 via the communication unit 24. (Step S8).
If it is determined that the image data is not suitable for image determination because the imaging conditions included in the supplementary information attached to the image data are different from the imaging conditions specified in the clinical trial conditions, In the institutional modality 40, image reconstruction (change of parameters, etc.) is performed, or re-shooting is performed when shooting is permitted. In the clinical trial institution terminal 20, the image data of the medical image newly generated by the modality 40 is retransmitted to the clinical trial data management apparatus 10 via the communication unit 24 (step S8).

  If the image data is suitable for image determination in step S10 (step S10; YES), the control unit 11 moves the image data stored in the RAM 16 to the image DB 172 and erases it from the RAM 16. . Then, the control unit 11 stores “1” in the QC confirmation result of the image data in the trail DB 171 and stores the storage location of the image data in the image DB 172 in the file path of the trail DB 171. When the QC confirmation result is “1” in the trail DB 171, the image data is disclosed to the judging doctor.

Next, in the clinical trial data management apparatus 10, the control unit 11 reports to the communication unit 14 that the image data obtained by photographing the relevant patient before medication in the relevant clinical trial and suitable for image determination is acquired. And transmitted to the pharmaceutical company terminal 50 (step S12).
The acquisition status of the image data may be viewable from the pharmaceutical company terminal 50 when the clinical trial data management apparatus 10 is accessed from the pharmaceutical company terminal 50.

  Next, in the clinical trial data management apparatus 10, the registration determination request is sent from the control unit 11 to the determination medical terminal 60 corresponding to each of the plurality of determination doctors determined in step S 7 for the corresponding clinical trial. (Step S13). Specifically, an e-mail for a registration determination request is transmitted to an e-mail address corresponding to each determination doctor. Registration determination refers to determining whether the patient is suitable for administration of the investigational drug or is an appropriate image as a baseline image.

  Each judging doctor who has received the registration judgment request accesses the clinical trial data management apparatus 10 from the judging doctor terminal 60, and based on the image data to be judged, the display unit 63 of the judging doctor terminal 60 displays the patient before medication. Image (baseline) is displayed. The determination doctor performs image determination by measuring the longest diameter of the target lesion on the image, and inputs a registration determination result by an operation from the operation unit 62. The input registration determination result is transmitted by the control unit 61 to the clinical trial data management apparatus 10 via the communication unit 64 (step S14).

  It is also determined whether or not the patient is suitable for the clinical trial for the patient before medication. For example, when a tumor such as cancer is treated with medication, depending on the location of the tumor in the body, the position of the tumor may not be clear in the photographed image due to ascites, etc. It is determined whether or not the shape of the target tumor can be clearly confirmed from the image.

  In the clinical trial data management apparatus 10, when the registration determination result is received by the communication unit 14, the received registration determination result is stored in the trail DB 171 in association with the determination target image data by the control unit 11. Specifically, the received registration determination result is associated with the baseline of the corresponding patient (trial ID) of the corresponding clinical trial and stored as the determination result of the corresponding determining physician. In addition, the control unit 11 reports to the pharmaceutical company terminal 50 via the communication unit 14 that the registration determination result by the corresponding determining doctor at the corresponding imaging timing (baseline) of the corresponding patient of the corresponding clinical trial has been acquired. Sent.

Next, moving to FIG. 9, dosing is started for the patient. When the registration determination based on the image is not performed, the medication is started without performing the processes of Step S13 and Step S14 after capturing an appropriate baseline image.
In the modality 40 of the clinical trial medical institution in which the clinical trial medical institution terminal 20 is installed, an image of the target site of each subject for the first time after medication is taken. In the clinical trial medical institution terminal 20, the image data of the medical image generated by the modality 40 is transmitted to the clinical trial data management apparatus 10 via the communication unit 24 (step S15).

  Since the processing from step S15 to step S19 is the same as the processing from step S8 to step S12 except that the shooting timing is different, the description thereof is omitted.

  Next, in the clinical trial data management apparatus 10, the control unit 11 sends an effect determination request to the determination medical terminal 60 corresponding to each of the plurality of determination doctors determined in step S7 for the corresponding clinical trial. (Step S20). Specifically, an e-mail for an effect determination request is transmitted to an e-mail address corresponding to each determination doctor.

  Each judging doctor who has received an effect judgment request accesses the clinical trial data management apparatus 10 from the judging doctor terminal 60, so that the patient image is displayed on the display unit 63 of the judging doctor terminal 60 based on the image data to be judged. Is displayed. The determination doctor performs image determination by measuring the longest diameter of the target lesion on the image, and inputs an effect determination result (effect determination report) by an operation from the operation unit 62. The result of the effect determination includes not only the measurement data of the size of the lesion, but also the presence / absence / size of the effect of the investigational drug (new guideline for determining the effect of treatment of solid cancer (RECIST guideline), revised version 1.1 reference). The input effect determination result is transmitted by the control unit 61 to the clinical trial data management apparatus 10 via the communication unit 64 (step S21).

  In the clinical trial data management apparatus 10, when the effect determination result is received by the communication unit 14, the received effect determination result is stored in the trail DB 171 in association with the determination target image data by the control unit 11. Specifically, the received effect determination result is stored in association with the corresponding imaging timing of the corresponding patient (trial ID) in the corresponding trial as the determination result of the corresponding determining doctor. In addition, the control unit 11 transmits a report indicating that the effect determination result by the corresponding determining doctor at the corresponding imaging timing of the corresponding patient of the corresponding clinical trial is acquired to the pharmaceutical company terminal 50 via the communication unit 14.

Next, in the clinical trial data management apparatus 10, the control unit 11 determines whether or not the imaging has been completed a required number of times based on the clinical trial implementation information corresponding to the clinical trial (step S22).
If the required number of imaging has not been completed (step S22; NO), the process returns to step S15, and the next imaging is performed in the modality 40 of the clinical trial institution. In the clinical trial institution terminal 20, the image data of the medical image generated by the modality 40 is transmitted to the clinical trial data management apparatus 10 via the communication unit 24.
In this way, the processes in steps S15 to S22 are repeated until the required number of times of shooting is completed.

  In step S22, when the required number of times of imaging has been completed (step S22; YES), the process proceeds to FIG. 10, and in the clinical trial data management apparatus 10, the control unit 11 makes a determination corresponding to each of a plurality of determination doctors in the relevant clinical trial. A comprehensive effect determination request is transmitted to the medical terminal 60 via the communication unit 14 (step S23). Specifically, an e-mail for a comprehensive effect determination request is transmitted to an e-mail address corresponding to each determination doctor.

  Each judging doctor who has received the request for comprehensive effect determination makes a comprehensive determination throughout the entire trial based on the image data and the measurement data of the lesion taken so far. (Refer to version 1.1 of the revised guideline for determining the therapeutic effect of solid cancer (RECIST guideline) 1.1). In addition, each judging doctor inputs the best overall effect (confirmation of the effect) by an operation from the operation unit 62 based on the overall effect determination result. The inputted overall effect determination result and the best overall effect are transmitted to the clinical trial data management apparatus 10 by the control unit 61 via the communication unit 64 (step S24).

  FIG. 11 shows an example of the overall effect determination result. The effect judgment results include the imaging time, target lesion information (increase rate (%), reduction rate (%), target lesion evaluation, etc.), non-target lesion information (non-target lesion evaluation, etc.), new lesion, comprehensive evaluation, etc. included.

  In the clinical trial data management apparatus 10, the comprehensive effect determination result and the best comprehensive effect received by the control unit 11 are associated with the corresponding patient of the corresponding clinical trial in the trail DB 171, and the comprehensive effect determination of the corresponding determining doctor is performed. Stored as result and best overall effect.

  Next, the comprehensive effect determination result and the best comprehensive effect for each patient by the control unit 11 for the corresponding clinical trial are sent to the pharmaceutical company terminal 50 via the communication unit 14 as the comprehensive effect determination report and the best comprehensive effect report. (Step S25).

  In the pharmaceutical company terminal 50, the control unit 51 displays the overall effect determination report and the best overall effect report on the display unit 53, and the overall effect determination report and the best overall effect report are confirmed. Based on the operation from the operation unit 52, the control unit 51 transmits a data lock instruction from the pharmaceutical company terminal 50 to the clinical trial data management apparatus 10 via the communication unit 54 (step S26).

  In the clinical trial data management apparatus 10, when the data lock instruction is received by the communication unit 14, the control unit 11 locks information related to the relevant clinical trial (step S27). Specifically, only browsing is permitted for information regarding the relevant clinical trials stored in the trail DB 171 and the image DB 172, and addition / change is prohibited. In addition, it is possible to back up information related to the clinical trial stored in the trail DB 171 and the image DB 172 to a non-rewritable medium such as a recording medium and store the state at that time.

  Next, the control unit 11 determines whether or not a predetermined period (data storage period) has elapsed since the data was locked (step S28). For example, for each trial, the date and time when the data was locked and the retention period were recorded, and whether the data retention period passed by comparing the period from the data lock date and time to the current date and the retention period Is judged. Alternatively, the storage end date may be recorded, and it may be determined whether the data storage period has elapsed based on whether the storage end date has been reached. If the data storage period has not elapsed since the data was locked (step S28; NO), the process returns to step S28.

  In step S28, when the data storage period has elapsed since the data was locked (step S28; YES), the data is stored in the trail DB 171 and the image DB 172 by the control unit 11 after confirming with a clinical trial client such as a pharmaceutical company. The information related to the relevant clinical trial is deleted (step S29).

Next, the control unit 11 transmits a business end notification about the corresponding clinical trial to the pharmaceutical company terminal 50 via the communication unit 14 (step S30).
Thus, the process in the clinical trial system 100 is completed.

  In the case where the pharmaceutical company requests the clinical trial contractor to withdraw data before the predetermined period has elapsed since the data was locked, the pharmaceutical company terminal 50 notifies the clinical trial data management device 10 of the data storage end notification. Is sent. The data storage end notification is a notification for instructing that the pharmaceutical company withdraws the data and manages the data by the pharmaceutical company itself. Since the subsequent management of the data is performed by the pharmaceutical company, the clinical trial data organization is no longer obligated to store the clinical trial data. Therefore, when a data storage end notification is received from the pharmaceutical company terminal 50 to the clinical trial data management apparatus 10 before the storage period elapses, the data is deleted even if the storage period has not elapsed.

  As described above, according to the present embodiment, it is possible to reduce the time for clinical trial work by improving the efficiency of collecting image data and determining the effect.

Specifically, since the clinical trial data management apparatus 10 collects image data from the clinical trial institution terminal 20 online, image data can be acquired immediately after imaging from the clinical trial institution, and the image data The time it takes to collect can be reduced.
In addition, when there is a defect in the image data, it is possible to notify the trial medical institution terminal 20 of a request for re-imaging or retransmission online, so that it is possible to reduce the time taken to collect the image data.

In addition, since the decision-making doctor can make an online decision at his or her own favorite time, it is not necessary to invite a plurality of decision-making doctors to the same venue at the same time, and the decision work time is shortened. be able to.
Further, by adopting a registration system for judging doctor candidates, it is possible to effectively distribute the judgment work in a specialized field.

  In addition, since the clinical trial requester (pharmaceutical company or the like) can confirm the acquisition status of the image data and the determination result provided from the clinical trial data management apparatus 10, the progress status can be confirmed in real time.

  In addition, after the clinical trial is completed, the clinical trial data management apparatus 10 prohibits the change of the information related to the clinical trial, so that the information related to the clinical trial can be stored. In addition, after the data storage period elapses, information regarding the clinical trial can be deleted.

  The description in the above embodiment is an example of a clinical trial system according to the present invention, and the present invention is not limited to this. The detailed configuration and detailed operation of each device constituting the system can be changed as appropriate without departing from the spirit of the present invention.

  For example, in the clinical trial data management apparatus 10, when image data is acquired from the clinical trial medical institution terminal 20, whether or not the imaging conditions included in the incidental information of the image data match a predetermined imaging condition, or Whether or not the image data is suitable for image determination may be determined based on one of whether or not the personal information is deleted from the incidental information of the image data.

  Further, the clinical trial data management apparatus 10 may provide the pharmaceutical company terminal 50 with either one of the acquisition status of the image data or the determination status of the determination result at a plurality of timings in the clinical trial.

  In the clinical trial data management apparatus 10, the determination item for determining whether or not the image data is suitable for image determination performed when the image data is received is not limited to the above-described example.

  In the above description, an example in which a ROM is used as a computer-readable medium storing a program for executing each process is disclosed, but the present invention is not limited to this example. As other computer-readable media, a non-volatile memory such as a flash memory and a portable recording medium such as a CD-ROM can be applied. A carrier wave may be applied as a medium for providing program data via a communication line.

DESCRIPTION OF SYMBOLS 10 Clinical trial data management apparatus 11 Control part 12 Operation part 13 Display part 14 Communication part 17 Storage part 20 Clinical trial medical institution terminal 21 Control part 24 Communication part 27 Storage part 30 PACS
40 modality 50 pharmaceutical company terminal 51 control unit 54 communication unit 57 storage unit 60 judgment medical terminal 61 control unit 64 communication unit 67 storage unit 100 clinical trial system 171 trail DB
172 Image DB
173 Decision doctor candidate correspondence table N1 communication network

Claims (8)

Data communication is possible via a network with a trial medical institution terminal installed in a trial medical institution that conducts a clinical trial of a new drug, and a judgment medical terminal used by a judgment doctor that judges the effect and safety of the new drug. A connected clinical trial data management device,
Image data acquisition means for acquiring image data of a target region of a patient in the clinical trial from the clinical trial medical institution terminal via the network, and storing the acquired image data in a storage means;
The determination result determined by the determination doctor based on the image data stored in the storage unit is acquired from the determination medical terminal via the network, and the acquired determination result corresponds to the determination target image data. A determination result acquisition means to be stored in the storage means,
A clinical trial data management device comprising:   The image data acquisition means determines whether the image data is suitable for image determination based on incidental information attached to the image data acquired from the clinical trial institution terminal, When it is determined that the acquired image data is suitable for image determination, the image data is stored in the storage means, and the acquired image data is determined not to be suitable for image determination The trial data management apparatus according to claim 1, wherein a request for retransmission of image data is transmitted to the trial medical institution terminal.   The image data acquisition means determines whether or not a shooting condition included in incidental information attached to the acquired image data matches a predetermined shooting condition and / or adds to the acquired image data. The clinical trial data management according to claim 2, wherein whether or not the acquired image data is suitable for image determination is determined based on whether or not personal information is deleted in the incidental information. apparatus.   The clinical trial data management apparatus according to any one of claims 1 to 3, further comprising a storage control unit that prohibits a change of information related to the clinical trial stored in the storage unit after the clinical trial is completed for each clinical trial. .   5. The clinical trial according to claim 4, wherein the storage control means erases information related to the clinical trial stored in the storage means after a predetermined period has elapsed since the clinical trial ended for each clinical trial. Data management device. A registration unit that registers a plurality of judgment doctor candidates and specialized fields in association with each other;
Extracting means for extracting a judgment doctor candidate corresponding to a specialized field related to the clinical trial from the plurality of registered judgment doctor candidates;
A selection means for selecting a judgment doctor who actually requests a judgment from the extracted judgment doctor candidates;
Determination request means for transmitting a determination request to the determining doctor terminal corresponding to the selected determining doctor;
The clinical trial data management apparatus according to any one of claims 1 to 5, further comprising: It is connected to a pharmaceutical company terminal installed in a pharmaceutical company requesting a clinical trial of the new drug through the network so that data communication is possible,
The clinical trial data management apparatus according to any one of claims 1 to 6, further comprising providing means for providing the pharmaceutical company terminal with the acquisition status of the image data and / or the acquisition status of the determination result. Used by a clinical trial data management device for managing information related to a clinical trial of a new drug, a clinical trial medical institution terminal installed in the clinical trial medical institution performing the clinical trial, and a judgment physician for judging the effect and safety of the new drug. A clinical trial system in which a judging doctor terminal is connected to a data communication device via a network,
The clinical trial data management device comprises:
Image data acquisition means for acquiring image data of a target region of a patient in the clinical trial from the clinical trial medical institution terminal via the network, and storing the acquired image data in a storage means;
The determination result determined by the determination doctor based on the image data stored in the storage unit is acquired from the determination medical terminal via the network, and the acquired determination result corresponds to the determination target image data. A determination result acquisition means to be stored in the storage means,
Clinical trial system.

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