KR102386414B1 - Apparatus and method for reporting a violation of a clinical trial - Google Patents

Abstract

Disclosed are an apparatus and method for reporting a violation of a clinical trial. According to the present invention, the method for reporting the violation of the clinical trial comprises: a) a step of providing a clinical trial schedule management service to a clinical trial target by linking with a user terminal of the clinical trial target; b) a step of receiving the report of the clinical trial target from the clinical trial target through the user terminal; c) a step of recognizing the content of the received report of the clinical trial target and words and sentences of the data of an examination organization provided by the examination organization; d) a step of drawing clinical trial violation information of the content of the received report of the clinical trial target by using the recognized words and sentences; and e) a step of providing the drawn clinical trial violation information to one or more of a server of the examination organization, a predesignated user terminal of the examination organization, and the user terminal of the clinical trial target. The present invention aims to provide an apparatus and method for reporting a violation of a clinical trial, which are capable of allowing direct communication between a clinical trial target and an examination organization.

Description

Apparatus and method for reporting a violation of a clinical trial

The present invention relates to a device and method for reporting violations in clinical trials.

In general, clinical trials are conducted by clinical trial investigators, monitors and inspectors. A clinical trial investigator is a person who conducts a clinical trial itself, administers a drug to a patient, and prepares the response and results. The monitor checks whether the clinical trial investigator is conducting the trial accurately according to the clinical trial plan. The inspector monitors whether the feedback on the clinical trial that takes place between the trial investigator and the monitor is accurate.

In the event of a violation of the subject's safety or rights and interests during the course of the clinical trial, a plan for the safety and protection of the subject's rights and interests is required. So, conventionally, an Institutional Review Board (IRB) has been established for each institution that conducts clinical trials. The Institutional Ethics Review Committee receives reports on safety or rights and interests-related violations that occur during clinical trials and takes appropriate measures.

However, there was a limitation that a clinical trial subject could not directly and promptly deliver violations related to their own safety and rights to the institutional ethics review committee, and there was a limitation that disadvantages could occur due to exposure of information or personal information when delivered over the wire.

Republic of Korea Patent Publication No. 10-1440926 (2014.09.05)

The present invention enables direct communication between the clinical trial subject and the deliberation institution, so that the clinical trial subject easily transmits violations related to their own safety and rights and interests to the deliberation institution, and exposure of the clinical trial subject's reports and personal information This is to provide a device and method for reporting violations in clinical trials that prevent

According to one aspect of the present invention, a method for reporting violations of clinical trials performed by a device for reporting violations of clinical trials is disclosed.

The method for reporting violations of a clinical trial according to an embodiment of the present invention comprises the steps of: a) providing a clinical trial schedule management service to the clinical trial subject through interworking with the user terminal of the clinical trial subject; b) using the user terminal Receiving the clinical trial subject report content from the clinical trial subject through, c) recognizing the words and sentences of the received clinical trial subject report content and the review institution data provided by the review institution, d) the recognized word and deriving clinical trial violation information of the received clinical trial subject report content using sentences, and e) transferring the derived clinical trial violation information to the server of the review institution, a pre-designated user terminal of the review institution, and the clinical trial and providing it to one or more of the user terminals of the test subject.

The deliberation institution data includes past judgment history information on major or minor cases in scientific and non-scientific communities related to clinical trial violations, and step c) includes the words of the clinical trial subject report and recognizing words and sentences used in the major or minor case in the sentence, the past judgment history information, recognizing the word corresponding to the major or minor case in the clinical trial subject report content, and the recognized word and recognizing the sentence corresponding to the major or minor case in the clinical trial subject report using

The clinical trial violation information includes the type of clinical trial violation indicating whether the clinical trial violation of the clinical trial subject report is a major or minor case in the scientific and non-scientific circles, respectively, in relation to the clinical trial violation. In the step d), it is determined whether the content of the clinical trial subject report corresponds to a major or minor case for each of the scientific community and the non-scientific community, and when at least one of the scientific community and the non-scientific community is a major, the clinical trial and determining that the subject-reported content is a major, and if both the scientific community and the non-scientific community are minor, determining that the clinical trial subject-reported content is minor.

The clinical trial violation information further includes the frequency of the clinical trial subject report of the clinical trial subject, and in step e), the clinical trial subject report content and the clinical trial violation information are transferred to the server of the review institution, the review institution provided to the user terminal designated in advance of the above, and depending on the violation of the clinical trial and the type of violation, measures to be taken for the hospital and clinical trial researcher where the relevant clinical trial was conducted, whether the clinical trial is continued, and measures for the subject of the clinical trial Feedback information including one or more of the clinical trial subjects is provided to the user terminal.

Storing clinical trial-related information including at least one of the clinical trial subject report content, the clinical trial violation information, and the feedback information, and providing statistical information generated using the accumulated clinical trial-related information include

According to another aspect of the present invention, a device for reporting violations of a clinical trial is disclosed.

A clinical trial violation reporting apparatus according to an embodiment of the present invention includes a memory for storing instructions and a processor for executing the instructions, wherein the instructions include: a) the clinical trial subject through interworking with a user terminal providing a clinical trial schedule management service to a clinical trial subject; b) receiving a clinical trial subject report from the clinical trial subject through the user terminal; c) the received clinical trial subject report content and a review institution Recognizing the words and sentences of the provided review institution data, d) deriving the clinical trial violation information of the received clinical trial subject report using the recognized words and sentences, and e) the derived clinical trial A method for reporting violations of a clinical trial comprising providing the violation information to one or more of a server of the review institution, a predefined user terminal of the review institution, and a user terminal of the clinical trial subject is performed.

The apparatus and method for reporting violations of a clinical trial according to an embodiment of the present invention enable direct communication between the clinical trial subject and the reviewing institution, so that the clinical trial subject can easily report violations related to their own safety and rights and interests to the reviewing institution It is possible to prevent the disclosure of reports and personal information of clinical trial subjects.

1 is a diagram schematically illustrating the configuration of a system in which a method for reporting violations of a clinical trial according to an embodiment of the present invention is performed.
2 is a flowchart illustrating a method for reporting violations of a clinical trial performed by the device for reporting violations of a clinical trial according to an embodiment of the present invention;
3 is a diagram schematically illustrating the configuration of a device for reporting violations of a clinical trial according to an embodiment of the present invention.

As used herein, the singular expression includes the plural expression unless the context clearly dictates otherwise. In this specification, terms such as "consisting of" or "comprising" should not be construed as necessarily including all of the various components or various steps described in the specification, some of which components or some steps are It should be construed that it may not include, or may further include additional components or steps. In addition, terms such as "...unit" and "module" described in the specification mean a unit that processes at least one function or operation, which may be implemented as hardware or software, or a combination of hardware and software. .

Hereinafter, various embodiments of the present invention will be described in detail with reference to the accompanying drawings.

1 is a diagram schematically illustrating the configuration of a system in which a method for reporting violations of a clinical trial according to an embodiment of the present invention is performed.

Referring to FIG. 1 , the apparatus 100 for reporting violations of clinical trials according to an embodiment of the present invention is communicatively connected with a system 200 for reviewing violations of clinical trials, and user terminals of clinical trial subjects It is possible to deliver the content of the violation report received from the deliberation agency system (200).

Here, the user terminal may be equipped with an application for a clinical trial subject for performing the method for reporting violations of a clinical trial according to an embodiment of the present invention, and the apparatus 100 for reporting violations of a clinical trial according to an embodiment of the present invention ), it is possible to provide clinical trial schedule management service and violation reporting service to clinical trial subjects.

In addition, the deliberation institution system 200 may include a server capable of performing the operations described below or a user terminal of a person in charge of performing clinical trial-related tasks at the deliberation institution. For example, the review body may be an Institutional Review Board (IRB). Hereinafter, for the convenience of understanding and explanation, it is assumed that the review institution is an institutional ethics review committee.

At this time, the clinical trial violation reporting device 100 uses the cloud database 300 for storing various clinical trial-related data provided by the institutional ethics review committee, clinical trial hospital, and clinical trial researcher to report violations to clinical trial subjects. Reporting services can be provided.

For example, the apparatus 100 for reporting violations of a clinical trial may be a server on which an artificial intelligence (AI) program is loaded. Therefore, the apparatus 100 for reporting violations of clinical trials may recognize words and sentences from various clinical trial-related data stored in the cloud database 300 and analyze cases using deep learning technology. For reference, deep learning is a part of machine learning, and it is a technology that can learn the principle of generating result values through self-learning without basic data. Here, machine learning is a technology capable of performing a judgment or prediction based on information obtained by analyzing a large amount of data based on an analysis algorithm and learning a computer with the analysis result.

The cloud database 300 is a consortium blockchain-based database, managed by participants belonging to the consortium, and accessible only by authorized users. Here, the consortium may be composed of an institutional ethics review committee, a clinical trial hospital, a clinical trial researcher, and the like.

That is, the cloud database 300 may be accessed by an institutional ethics review committee, a clinical trial hospital, and a clinical trial researcher to store various clinical trial-related data. In addition, the cloud database 300 may store various clinical trial-related data transmitted or received by the apparatus 100 for reporting violations of a clinical trial. That is, the cloud database 300 may be operated as a kind of dedicated database of the apparatus 100 for reporting violations of a clinical trial according to an embodiment of the present invention.

Such a cloud database 300 stores hospital information, researcher information, protocol information, institutional ethics review committee information, regulations and legal information, institutional ethics review committee data, clinical trial subject report content, data necessary for analysis, and analysis results. can

For example, hospital information includes hospital name and location information, researcher information includes researcher name, role, and ongoing clinical trial information, and protocol information includes clinical trial schedule information, test method information, and consent form of clinical trial subjects Including, the institutional ethics review committee information includes the name of the institution and information on ongoing clinical trials, and the institutional ethics review committee data includes historical judgment history information and clinical trials on major or minor cases in the scientific community related to clinical trial violations. It includes historical judgment history information on major or minor cases in the non-scientific community related to test violations. and cases, and the analysis result may include a major or minor determination result, historical information on scientific and non-scientific past judgments used for case analysis, and the frequency of reports.

Here, the 'science community' may include fields such as medicine, pharmacy, oriental medicine, dentistry, and nursing, and the 'non-scientific world' may include fields such as law and religion. In addition, major cases related to clinical trial violations may include matters that negatively affect the rights, safety, welfare, etc. of the research subjects during the clinical trial process, and minor cases related to clinical trial violations are related to the research subjects' rights , safety, welfare, etc. may include matters that do not negatively affect.

2 is a flowchart illustrating a method for reporting violations of a clinical trial performed by the device for reporting violations of a clinical trial according to an embodiment of the present invention.

In step S210, the clinical trial violation reporting device 100 provides a clinical trial schedule management service to the clinical trial subject through interworking with the user terminal of the clinical trial subject.

For example, the clinical trial violation reporting device 100 provides a notice including a list of available services such as a clinical trial scheduling service and a violation reporting service to the clinical trial subject, and the clinical trial schedule from the clinical trial subject Administrative services may be requested. And, when the clinical trial violation reporting device 100 receives a request for a clinical trial schedule management service, after receiving hospital information, participating clinical trial information, and clinical trial subject information from the clinical trial subject, the clinical trial subject receives a clinical trial You can view schedules and set reminder times. Here, the notification time may be set to 7:00 PM three days before the visit, 9:00 AM one day before the visit, and 9:00 AM on the day of the visit. Thereafter, when the set notification time arrives, the clinical trial violation reporting apparatus 100 may notify the user through the user terminal of the clinical trial subject.

In step S220 , the clinical trial violation reporting device 100 receives the clinical trial subject report from the clinical trial subject through the user terminal of the clinical trial subject.

Here, the contents of the clinical trial subject report may include report types, research methods, study standards, study schedules, and violation cases. As described above, the clinical trial subject report content may be stored in the cloud database 300 .

Clinical trial violation cases are information created by clinical trial subjects and may include various contents that occur or are experienced in the course of the clinical trial schedule management.

In step S230, the clinical trial violation reporting device 100 recognizes the words and sentences of the received clinical trial subject report content and the institutional ethics review committee data provided by the institutional ethics review committee. Here, the institutional ethics review committee data may be stored in the cloud database 300 of the consortium consisting of the institutional ethics review committee, clinical trial hospital, and clinical trial researchers, as described above.

That is, the clinical trial violation reporting device 100 may recognize the words and sentences of the clinical trial subject report and the words and sentences used in major or minor cases in the past. In addition, the clinical trial violation reporting apparatus 100 may recognize a word used in a major or minor case in the clinical trial subject report content, and expand the recognized word to recognize a sentence.

In step S240, the clinical trial violation reporting device 100, recognized words and sentences, past judgment history information about major or minor cases related to scientific and non-scientific clinical trial violations, stored in the cloud database 300 The results are derived by comprehensively analyzing the data required for analysis. Here, the data required for analysis are information and cases on regulations and laws in the scientific community, and information and cases on research in the non-scientific world.

That is, the clinical trial violation reporting device 100 may derive as a result whether the clinical trial subject report content is major or minor for each of the scientific and non-scientific worlds. And, as shown in the table below, only when both the scientific community and the non-scientific community are minor, the content of the clinical trial subject report is finally derived as minor, and when at least one of the scientific and non-scientific community is major, the clinical trial subject is finally It can be derived that the report content is major.

scientific community non-scientific result major major major major minor major minor major major minor minor minor

For example, violations of clinical trials can be presented as shown in the table below.

category major minor No protocol deviation informed consent Clinical research procedures performed prior to signing the initial informed consent
Signature and undated initial consent in accordance with local regulatory guidelines
New clinical research procedures performed before the subject gave consent again
Re-consent with updated risk language or unsigned critical safety information No need to initialize participant information on every page, if required by local regulations or IRB/EC Management items such as:
Subject did not use the date format requested by the subject or did not sign the line requested by the subject Include/Exclude Subjects participated in clinical trials even though they violated the criteria for exclusion research intervention Subjects who received the wrong treatment or the wrong dose
Subject received wrong study treatment
If the subject has the wrong dose unit, route of administration and/or frequency of administration, or the product has expired
Subject non-compliance with test drug/treatment (e.g., above or below a protocol-specified threshold, overdose)
The subject took the research drug that was not suitable for use outside the storage temperature Subjects received study drug outside the storage temperature but did not take it
or if it was taken but it is a research drug suitable for use
In case of stratification error / In case of forgetting stratification Study drug was out of storage temperature but not delivered to subject
The study drug had a change in storage temperature before it was delivered to the subject, but it was within an acceptable range.

Note: Protocol deviations may be considered GCP issues for resolution outside of the procedure research procedure Missing safety or effectiveness assessments related to primary or primary secondary endpoints
Key safety or efficacy endpoint data collected for equipment that was not properly calibrated at the time of protocol definition
Certain personnel do not have specific training on key or critical protocol specific procedures (e.g., in the area of neuroscience therapy, raters are not trained on how to evaluate key research endpoints) Procedures not directly related to participant safety (e.g., outcome studies)
Repeated validity measurements not performed after predefined endpoints
Missing procedures that do not affect the reliability of the study results (e.g. exploratory analysis)
Missing laboratory measurements that are not part of a key or critical safety or efficacy end product
Non-critical procedures performed in the specified window
No calibration of equipment associated with non-key safety or efficacy endpoints at the time points defined in the protocol Estimated quantity of lab collection kit not available on site
Failure to calibrate equipment on days not used to obtain participant data
Training of CRAs or other sponsoring personnel is not a protocol deviation

NOTE: Training in general is not a protocol deviation
It is an issue that requires corrective action and appropriate follow-up.

For reference, an Institutional Ethics Review Board (IRB) may be linked to each hospital that conducts clinical trials, and one Institutional Ethics Review Board (IRB) may be linked to one or more hospitals. The Institutional Ethics Review Board (IRB) may inquire about clinical trial related information at the hospital it is affiliated with if it is given specific authority.

In step S250, the device for reporting violations of the clinical trial 100, reports to the institutional ethics review committee according to the derived results or performs feedback to the clinical trial subjects.

That is, the violation reporting device 100 of the clinical trial can perform both the report of the institutional ethics review committee and the feedback to the subject of the clinical trial when the derived result is a major, and when the derived result is a minor, the clinical trial Only feedback to the subject can be performed.

The clinical trial violation reporting device 100 may report the clinical trial subject report content to the institutional ethics review committee through the institutional ethics review committee system 200 and notify that the clinical trial subject report content is major.

Accordingly, the Institutional Ethics Review Committee can conduct a meeting using the clinical trial subject report notified to the major, draw measures from the meeting result, and follow up on the clinical trial subject according to the derived measures.

Here, the follow-up measures are the measures received by the hospital and clinical trial researcher who conducted the clinical trial according to the review results of the Institutional Ethics Review Board (IRB), whether the clinical trial is continued, and the actions taken for the clinical trial researcher and the clinical trial subject and the like.

On the other hand, the clinical trial violation reporting device 100, when the derived result is major, informs the clinical trial subject that the report has been received to the institutional ethics review committee, and guides them to check the progress procedure, thereby giving the clinical trial subject feedback can be provided.

In addition, the clinical trial violation reporting device 100 may provide feedback to the clinical trial subject by notifying the clinical trial subject that the report has not been received by the institutional ethics review committee when the derived result is minor. there is. For example, the clinical trial violation reporting device 100 may inform the clinical trial subject that the reason the report was not received and that the report is stored and used for analysis of the report later.

According to such feedback, the clinical trial violation reporting device 100 stores the results of the clinical trial subject report as major or minor and the scientific and non-scientific past judgment history information used for case analysis in the cloud database 300 ) can be saved as analysis results.

In step S260, the clinical trial violation reporting device 100 calculates the frequency of the received clinical trial subject report and reports it to the institutional ethics review committee.

That is, as the clinical trial subject report content is continuously stored in the cloud database 300 , the clinical trial violation reporting device 100 calculates the frequency of the clinical trial subject report derived as major and minor, and derives it as a major The calculated frequency of the clinical trial subject report may be stored as an analysis result in the cloud database 300 and reported to the institutional ethics review committee.

Here, in the case of a major case, the clinical trial violation reporting device 100 can report to the Institutional Ethics Review Board (IRB), and in the case of a minor case, it is stored in the cloud database 300 and detailed like a major case. Content may not be reported. The Institutional Ethics Review Board (IRB) can view the contents of minor cases by referring to the frequency of minor cases in the future.

The clinical trial violation reporting device 100 may provide statistical information related to the clinical trial violation when read by the institutional ethics review board (IRB). For example, statistical information may be provided for each type of clinical trial violation, ie, major or minor case, and statistical information may be provided for each clinical trial. The statistical information may include visualization contents such as graphs and tables.

3 is a diagram schematically illustrating the configuration of a device for reporting violations of a clinical trial according to an embodiment of the present invention.

Referring to FIG. 3 , the apparatus for reporting violations of a clinical trial according to an embodiment of the present invention includes a processor 110 , a memory 120 , a communication unit 130 , and an interface unit 140 .

The processor 110 may be a CPU or a semiconductor device that executes processing instructions stored in the memory 120 .

Memory 120 may include various types of volatile or non-volatile storage media. For example, the memory 120 may include ROM, RAM, or the like.

For example, the memory 120 may store instructions for performing a method for reporting violations of a clinical trial according to an embodiment of the present invention.

The communication unit 130 is a means for transmitting and receiving data with other devices through a communication network.

The interface unit 140 may include a network interface and a user interface for accessing a network.

On the other hand, the components of the above-described embodiment can be easily grasped from a process point of view. That is, each component may be identified as each process. In addition, the process of the above-described embodiment can be easily understood from the point of view of the components of the apparatus.

In addition, the technical contents described above may be implemented in the form of program instructions that can be executed through various computer means and recorded in a computer-readable medium. The computer-readable medium may include program instructions, data files, data structures, etc. alone or in combination. The program instructions recorded on the medium may be specially designed and configured for the embodiments or may be known and available to those skilled in the art of computer software. Examples of the computer-readable recording medium include magnetic media such as hard disks, floppy disks and magnetic tapes, optical media such as CD-ROMs and DVDs, and magnetic media such as floppy disks. - includes magneto-optical media, and hardware devices specially configured to store and execute program instructions, such as ROM, RAM, flash memory, and the like. Examples of program instructions include not only machine language codes such as those generated by a compiler, but also high-level language codes that can be executed by a computer using an interpreter or the like. A hardware device may be configured to operate as one or more software modules to perform the operations of the embodiments, and vice versa.

The above-described embodiments of the present invention have been disclosed for purposes of illustration, and various modifications, changes, and additions will be possible within the spirit and scope of the present invention by those skilled in the art having ordinary knowledge of the present invention, and such modifications, changes and additions should be regarded as belonging to the following claims.

100: Violation reporting device for clinical trials
200: Deliberation agency system
300: cloud database
110: processor
120: memory
130: communication department
140: interface unit

Claims (6)

In the method for reporting violations of clinical trials performed by the device for reporting violations of clinical trials,
a) providing a clinical trial schedule management service to the clinical trial subject through interworking with the clinical trial subject's user terminal;
b) receiving a clinical trial subject report from the clinical trial subject through the user terminal;
c) recognizing the words and sentences of the received clinical trial subject report content and the review institution data provided by the review institution;
d) deriving clinical trial violation information of the received clinical trial subject report content using the recognized words and sentences; and
e) A method for reporting violations of clinical trials, comprising providing the derived clinical trial violation information to one or more of a server of the review institution, a pre-designated user terminal of the review institution, and a user terminal of the clinical trial subject.
According to claim 1,
The deliberation institution data is,
Includes historical judgment history information on major or minor cases in scientific and non-scientific circles related to clinical trial violations;
Step c) is,
recognizing the words and sentences of the clinical trial subject report content, and the words and sentences used in the major or minor case in the past judgment history information;
recognizing a word corresponding to the major or minor case in the clinical trial subject report; and
and recognizing a sentence corresponding to the major or minor case in the clinical trial subject report using the recognized word.
3. The method of claim 2,
The clinical trial violation information is,
Including the type of clinical trial violation that indicates whether the clinical trial violation of the clinical trial subject report is a major or minor case in the scientific and non-scientific circles, respectively, in relation to the clinical trial violation in case of a clinical trial violation;
Step d) is,
It is determined whether the contents of the clinical trial subject report correspond to major or minor cases for each scientific and non-scientific community,
when at least one of the scientific community and the non-scientific community is a major, determining that the clinical trial subject report is a major; and
and determining that the content of the clinical trial subject report is minor when both the scientific community and the non-scientific community are minor.
4. The method of claim 3,
The clinical trial violation information is
Further comprising the frequency of the clinical trial subject report of the clinical trial subject,
Step e) is,
Providing the clinical trial subject report and the clinical trial violation information to a server of the review institution, a pre-designated user terminal of the review institution,
According to the violation of the clinical trial and the type of violation, feedback information including one or more of the actions taken for the hospital where the clinical trial was conducted and the researcher of the clinical trial, whether the clinical trial is continued, and the measures for the subject of the clinical trial Violation reporting method of a clinical trial, characterized in that provided to the user terminal of the clinical trial subject.
5. The method of claim 4,
storing clinical trial-related information including at least one of the clinical trial subject report content, the clinical trial violation information, and the feedback information; and
Violation reporting method of a clinical trial, characterized in that it further comprises the step of providing statistical information generated using the accumulated clinical trial-related information.
In the clinical trial violation reporting device,
memory to store instructions; and
A processor that executes the instructions,
The command is
a) providing a clinical trial schedule management service to the clinical trial subject through interworking with the clinical trial subject's user terminal;
b) receiving a clinical trial subject report from the clinical trial subject through the user terminal;
c) recognizing the words and sentences of the received clinical trial subject report content and the review institution data provided by the review institution;
d) deriving clinical trial violation information of the received clinical trial subject report content using the recognized words and sentences; and
e) a method for reporting violations of a clinical trial comprising the step of providing the derived clinical trial violation information to one or more of a server of the review institution, a pre-designated user terminal of the review institution, and a user terminal of the clinical trial subject Violation reporting device for clinical trials, characterized in that it is performed.

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