WO2018190480A1 - Système de mise en correspondance d'informations d'essai clinique entre des volontaires d'essai clinique et une institution médicale conduisant un essai clinique - Google Patents

Système de mise en correspondance d'informations d'essai clinique entre des volontaires d'essai clinique et une institution médicale conduisant un essai clinique Download PDF

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Publication number
WO2018190480A1
WO2018190480A1 PCT/KR2017/012106 KR2017012106W WO2018190480A1 WO 2018190480 A1 WO2018190480 A1 WO 2018190480A1 KR 2017012106 W KR2017012106 W KR 2017012106W WO 2018190480 A1 WO2018190480 A1 WO 2018190480A1
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WO
WIPO (PCT)
Prior art keywords
clinical trial
volunteer
information
clinical
questionnaire
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PCT/KR2017/012106
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English (en)
Korean (ko)
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이병일
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주식회사 에이치비에이
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Publication of WO2018190480A1 publication Critical patent/WO2018190480A1/fr

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    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/20—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires

Definitions

  • the present invention relates to clinical trial information matching technology, and more particularly, to a system for matching clinical trial information between a clinical trial volunteer and a clinical trial administration medical institution online.
  • the present invention has been made to solve the above-mentioned problems of the prior art, collects the clinical trial volunteer recruitment provided from the clinical institution in charge of the investigation online, and the basic digital questionnaire information and clinical trial volunteer questionnaire information required for the clinical trial
  • the task is to provide a clinical trial information matching system between the clinical trial volunteer and the clinical institution in charge of the clinical trial that can be digitized and matched to screen and filter the subjects eligible or ineligible to meet the clinical trial selection criteria.
  • an embodiment of the present invention is a volunteer volunteer storage module for receiving the basic clinical information and body information of the clinical trial volunteer terminal and the clinical trial volunteer terminal with the clinical trial support app is installed And a collection module for searching and collecting online clinical trial volunteer recruitment announcements announced from a clinical trial supervision medical institution, a classification module for classifying the collected clinical trial volunteer recruitment announcements, and the clinical trial volunteer recruitment information.
  • a generation module for generating and storing a basic digital questionnaire, a basic digital questionnaire providing module for providing the clinical trial volunteer recruitment notice and the basic digital questionnaire to the clinical trial volunteer terminal, and the basic digital questionnaire provided to the clinical trial volunteer terminal According to the phase Determining the clinical trial eligibility or ineligibility by comparing the clinical trial volunteer questionnaire generation module for generating the clinical trial volunteer questionnaire according to the information transmitted from the clinical trial volunteer terminal, and the basic digital questionnaire table information and the clinical trial volunteer questionnaire information Including a module, a clinical trial information integrated server comprising a notification module for notifying the clinical trial volunteer terminal whether qualified or ineligible, and a qualified questionnaire providing module for providing the qualified clinical trial volunteer questionnaire information to the clinical investigation subject medical institution Provide a clinical trial information matching system between the clinical trial volunteer and the clinical institution administering the trial.
  • the classification module may generate the clinical trial volunteer recruitment information by classifying the collected clinical trial volunteer recruitment announcement by disease name, medical department, body part, and region.
  • the mobile terminal may further include an interview request information transmission module for transmitting the interview request information requested from the clinical trial administration medical institution to the qualified volunteer terminal.
  • the method may further include an additional digital questionnaire providing module for generating an additional digital questionnaire requested by the clinical trial managing medical institution and providing it to the qualified volunteer terminal.
  • an additional digital questionnaire providing module for generating an additional digital questionnaire requested by the clinical trial managing medical institution and providing it to the qualified volunteer terminal.
  • said additional digital questionnaire may comprise a short answer questionnaire.
  • the foreign clinical trial information site may further include a translation module for providing translation into the Korean clinical trial information provided in a foreign language.
  • the determination module may further determine clinical trial eligibility or ineligibility by analyzing the clinical trial volunteer questionnaire and filtering the clinical trial duplicate support within a specific period of time.
  • the apparatus may further include a registration and management module configured to receive and register the clinical trial administration medical institution information and the clinical trial volunteer recruitment information from the clinical trial administration medical institution.
  • a registration and management module configured to receive and register the clinical trial administration medical institution information and the clinical trial volunteer recruitment information from the clinical trial administration medical institution.
  • the clinical trial volunteer information for the specific clinical trial is preliminarily received and stored from the clinical trial volunteer terminal for a specific clinical trial that is not announced by the clinical trial supervisory medical institution, and later, the clinical trial host medical institution.
  • the clinical trial volunteer recruitment notification for the specific clinical trial is registered from the notification
  • the clinical trial volunteer recruitment registration is notified to the clinical trial volunteer terminal
  • the clinical trial volunteer information received in advance includes the notification of the specific clinical trial registration notification.
  • a non-registered clinical trial processing module including expiration date information, for notifying the clinical study volunteer terminal whether the specific clinical trial registration notification validity period is extended at the end of the validity period, and discontinuing or extending the registration notification thereto. It may also include.
  • the information collected from the clinical trial volunteers announced by a pharmaceutical company, each medical group, a medical institution, or a clinical trial institute is collected and digitalized to match the basic digital questionnaire information required for the clinical trial with the corresponding clinical trial volunteer questionnaire information.
  • the most suitable clinical trial volunteers can be easily selected as qualified and ineligible candidates, and among the qualified candidates, duplicated clinical trial volunteers can be filtered to significantly reduce the manpower and costs involved in recruiting the clinical trial volunteers and proceeding of the clinical trial. By making it possible to reduce, there is an effect that can contribute to the desirable medical ethics and health promotion of clinical volunteers.
  • FIG. 1 is a schematic configuration diagram of a clinical trial information matching system between a clinical trial volunteer and a clinical trial supervising medical institution according to an embodiment of the present invention.
  • FIG. 1 is a schematic configuration diagram of a clinical trial information matching system between a clinical trial volunteer and a clinical trial supervising medical institution according to an embodiment of the present invention.
  • a clinical trial information matching system between a clinical trial volunteer and a clinical trial administration medical institution, the clinical trial volunteer terminal 100; And collecting and classifying the recruitment announcement of clinical trial volunteers, generating a basic digital questionnaire and providing it to the clinical trial volunteer terminal 100, and generating and comparing the clinical trial volunteer questionnaire to determine the eligibility to the clinical trial volunteer terminal 100. Consists of a clinical trial information integrated server (200) to notify and provide a qualified questionnaire to the medical institution administering the clinical trial.
  • the clinical trial volunteer terminal 100 receives and installs a clinical trial support app from the clinical trial information integrated server 200.
  • Clinical trial information integrated server 200 Volunteer information storage module 210, collection module 220, classification module 230, generation module 240, basic digital questionnaire providing module 250, clinical trial volunteer questionnaire generation Module 260, a determination module 270, and a qualified questionnaire providing module 280.
  • the volunteer information storage module 210 receives and stores basic personal information and body information of the clinical trial volunteer from the clinical trial volunteer terminal 100.
  • basic personal information includes gender, age (date of birth), contact information (email or mobile phone), and local information (volunteer address).
  • Physical information includes past and current medical history, weight, height, weight and height, BMI index, Blood type information, whether they have participated in the trial, whether they have participated in the trial within a specific time period (eg, within the last three months), or whether they smoked and drank, and how much and how much they smoked.
  • the collection module 220 retrieves and collects the clinical trial volunteers announced from the clinical trial subject medical institution 300, that is, the pharmaceutical company, each medical group, the medical institution, or the clinical trial conducting institution, and stores them in a DB (not shown). do.
  • the classification module 230 classifies the recruitment notification of the clinical trial volunteers collected by the collection module 220.
  • the classification module 230 classifies the collected clinical trial volunteer recruitment announcements by disease name, medical department, body part, and region. Information on recruitment of clinical trial volunteers can be generated by classifying the clinical trial subject medical institution location).
  • the classification module 230 may include cancer (especially lung cancer, non-small cell lung cancer, adenocarcinoma, gastric cancer, breast cancer, rectal cancer, lymphoma or multiple myeloma), diabetes, arthritis, hepatitis, leukemia, high blood pressure, Alzheimer's disease, ulcer or asthma.
  • cancer especially lung cancer, non-small cell lung cancer, adenocarcinoma, gastric cancer, breast cancer, rectal cancer, lymphoma or multiple myeloma
  • diabetes especially lung cancer, non-small cell lung cancer, adenocarcinoma, gastric cancer, breast cancer, rectal cancer, lymphoma or multiple myeloma
  • arthritis especially hepatitis, leukemia, high blood pressure, Alzheimer's disease, ulcer or asthma.
  • the generation module 240 generates and stores a basic digital questionnaire table for questioning essential items comprehensively corresponding to the clinical trial volunteer recruitment announcement information generated by the classification module 240.
  • the basic digital questionnaire is a pre-test questionnaire, and includes gender, age (date of birth), local information (volunteer address), weight, height, blood type information, clinical trial participation experience, and participation in clinical trial within a specific time period (for example, within three months). Include multiple-choice questions about experience, or whether smoking and drinking, and the amount and amount of smoking.
  • the basic digital questionnaire providing module 250 divides the detailed clinical trial volunteer recruitment announcement and the basic digital questionnaire provided by the clinical trial supervising medical institution 300 by disease name, medical department, body part, and region into the clinical trial volunteer terminal 100. It can be provided as a clinical trial support app, but can also be provided as a web service.
  • the clinical trial volunteer questionnaire generation module 260 generates a clinical trial volunteer questionnaire according to the questionnaire content information inputted according to the basic digital questionnaire provided to the clinical trial volunteer terminal 100 and transmitted from the clinical trial volunteer terminal 100.
  • the determination module 270 compares the basic digital questionnaire information and the clinical trial volunteer questionnaire information to determine the clinical trial eligibility or ineligibility of the clinical trial volunteer suitable for the clinical trial request.
  • the determination module 270 may additionally determine the clinical trial eligibility or eligibility by analyzing the clinical trial volunteer questionnaire to filter (screen) the clinical trial overlap support within a specific period of time.
  • the notification module 270 notifies the clinical trial volunteer terminal 100 whether it is eligible or ineligible by SNS, text or e-mail to promptly notify.
  • Eligible questionnaire providing module 280 the qualified clinical trial volunteer questionnaire information is sent to SNS, text or e-mail to the clinical trial host medical institution 300 to provide quickly.
  • the clinical trial information integrated server 200 may further include an interview request information transmitting module 291 for transmitting the interview request information requested from the clinical trial administration medical institution 300 to the qualified volunteer terminal 100.
  • interview request information transmission module 291 may perform a task of the call center for subsequent services.
  • the clinical trial information integrated server 200 by generating an additional digital questionnaire requested by the clinical trial supervision medical institution 300, further comprises an additional digital questionnaire providing module 292 to provide to the qualified volunteer terminal 100. Can be.
  • the additional digital questionnaire providing module 292 may provide an additional digital questionnaire including an additional or detailed subjective questionnaire according to the request of the clinical institution.
  • the basic digital questionnaire quickly filters basic or standard questionnaire information that is comprehensively applied to clinical trials that are not common or have low frequency of clinical trial registration, and prevents duplication of clinical trial volunteers within a certain period of time. Participation in clinical trials can be avoided, and the additional digital questionnaire transmits the interview request information to the qualified volunteer terminal 100 so that the candidates who are more optimized for the clinical trial can be selected.
  • the clinical trial information integration server 200 may further include a translation module 293 which translates and provides domestic clinical trial information provided in a foreign language to an overseas clinical trial information site.
  • the translation module 293 is an artificial intelligence specialized for translation, and should announce the clinical trial information to the Korea Food and Drug Administration or related overseas sites according to the clinical trial disclosure principle. In order to improve the accessibility and understanding of the translation into Korean may be provided to the clinical trial volunteer terminal (100).
  • the clinical trial information integrated server 200 receives and registers the clinical trial subject medical institution information and the clinical trial volunteer recruitment information (for example, the recruitment period and the number of employees) directly from the clinical trial supervising medical institution 300 without individual collection. And a registration and management module 294 for managing.
  • the clinical trial volunteer information for a specific clinical trial is received and stored in advance from the clinical trial volunteer terminal 100, and the subsequent clinical trial administration
  • the clinical trial volunteer recruitment terminal 100 may further include an unregistered clinical trial processing module 295 for notifying the clinical trial volunteer recruitment registration.
  • the unregistered clinical trial processing module 295 may pre-populate the clinical trial volunteer information from the clinical trial volunteer terminal 100, that is, before the clinical trial notification.
  • the clinical trial information integrated server 200 is the clinical trial volunteer terminal (100) to notify the recruitment notification of clinical trial volunteer recruitment and notification of clinical trial volunteer recruitment via SNS, text or e-mail.
  • the clinical trial volunteer information received in advance includes the expiration date information of the specific clinical trial registration notification, and the unregistered clinical trial processing module 295 determines whether the clinical trial registration notification validity period is extended at the end of the expiration date. Notification to the volunteer terminal 100 may be processed to stop or extend the registration notification for this.
  • the restriction on access to the clinical trial information limited by the clinical institution or regional medical institution and the regional trial is removed, and the excessive clinical trial eligibility call of the clinical trial volunteers is greatly reduced. Work efficiency can be improved, and transparent volunteer information management can ensure correct medical ethics.
  • the module may further include modules for classifying, classifying, generating, storing, providing, selecting, determining, and notifying bioequivalence tests.
  • the clinical institution managing the study encompasses the relevant server of the clinical research institution or the terminal of the clinical research institution.
  • the present invention collects the clinical trial volunteer recruitment announcement provided from the clinical research institute, and digitalizes and matches the basic digital questionnaire information required for the clinical trial and the clinical trial volunteer questionnaire information. Screening and filtering to make it easier to select the most appropriate clinical trial volunteers for the clinical trial as eligible and ineligible persons, and to filter the duplicated clinical trial volunteers among the eligible candidates, and to participate in the clinical trial recruitment and clinical trial process. And significant cost savings, which can contribute to favorable medical ethics and health promotion of clinical volunteers, and can remove restrictions on access to clinical trial information limited by the clinical institution or region. Eligibility Statement Significantly reduce the number of calls to improve work efficiency, and it is very useful industrially to implement the right medical ethics with transparent and correct clinical trial volunteer information management.

Abstract

La présente invention concerne un système de mise en correspondance d'informations d'essai clinique entre des volontaires d'essai clinique et une institution médicale conduisant un essai clinique, comprenant : un terminal de volontaire d'essai clinique ; et un serveur d'intégration d'informations d'essai clinique pour collecter et catégoriser des avis de recrutement de volontaires d'essai clinique, générer un dossier d'examen médical numérique de base et fournir celui-ci à un terminal des volontaires d'essai clinique, comparer et déterminer des dossiers d'examen médical éligibles parmi des dossiers d'examen médical des volontaires d'essai clinique, et fournir les dossiers d'examen médical éligibles à l'institution clinique conduisant l'essai clinique. Il en résulte que la limitation de l'accès aux informations d'essai clinique, qui est limité par des institutions médicales conduisant un essai clinique ou par région, peut être résolue, le rendement de travail peut être accru en réduisant de manière significative les appels d'interrogation excessifs effectués par des volontaires d'essai clinique concernant l'éligibilité d'essai clinique, et une éthique médicale appropriée peut être observée en gérant de manière transparente les informations de volontaires d'essai clinique.
PCT/KR2017/012106 2017-04-11 2017-10-30 Système de mise en correspondance d'informations d'essai clinique entre des volontaires d'essai clinique et une institution médicale conduisant un essai clinique WO2018190480A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
KR20170046914 2017-04-11
KR10-2017-0046914 2017-04-11
KR10-2017-0086258 2017-07-07
KR20170086258 2017-07-07

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WO2018190480A1 true WO2018190480A1 (fr) 2018-10-18

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020099570A1 (en) * 2000-08-24 2002-07-25 Knight Stephen C. Recruiting a patient into a clinical trial
US20060149602A1 (en) * 2003-05-14 2006-07-06 Clinilabs, Inc. Methods and systems for online clinical trial screening
KR20100038623A (ko) * 2008-10-06 2010-04-15 주식회사 더마프로 임상 피험자 모집 시스템 및 방법
JP2011233066A (ja) * 2010-04-30 2011-11-17 Huma Corp 被験者募集方法、仲介者のサーバ、ソフトウェア、記録媒体
US20140303999A1 (en) * 2011-11-07 2014-10-09 Mitchell D. Efros Method for creating and using registry of clinical trial participants

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020099570A1 (en) * 2000-08-24 2002-07-25 Knight Stephen C. Recruiting a patient into a clinical trial
US20060149602A1 (en) * 2003-05-14 2006-07-06 Clinilabs, Inc. Methods and systems for online clinical trial screening
KR20100038623A (ko) * 2008-10-06 2010-04-15 주식회사 더마프로 임상 피험자 모집 시스템 및 방법
JP2011233066A (ja) * 2010-04-30 2011-11-17 Huma Corp 被験者募集方法、仲介者のサーバ、ソフトウェア、記録媒体
US20140303999A1 (en) * 2011-11-07 2014-10-09 Mitchell D. Efros Method for creating and using registry of clinical trial participants

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