WO2018190479A1 - Procédé de mise en correspondance d'informations d'essai clinique entre des volontaires d'essai clinique et une institution médicale effectuant un essai clinique - Google Patents
Procédé de mise en correspondance d'informations d'essai clinique entre des volontaires d'essai clinique et une institution médicale effectuant un essai clinique Download PDFInfo
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- WO2018190479A1 WO2018190479A1 PCT/KR2017/012104 KR2017012104W WO2018190479A1 WO 2018190479 A1 WO2018190479 A1 WO 2018190479A1 KR 2017012104 W KR2017012104 W KR 2017012104W WO 2018190479 A1 WO2018190479 A1 WO 2018190479A1
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- clinical trial
- volunteer
- information
- clinical
- medical institution
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Classifications
-
- 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 a clinical trial information matching technology, and more particularly, to a method for matching clinical trial information between a clinical trial volunteer and a clinical research institute or a research institute.
- 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 method for matching clinical trial information between clinical trial volunteers and clinical research institutes that can be digitally matched and screened and filtered eligible or ineligible subjects.
- an embodiment of the present invention is to receive and install the clinical trial support app from the clinical trial information integrated server to the clinical trial volunteer terminal and the clinical trial information integrated server, from the clinical trial volunteer terminal Receiving and storing basic personal and physical information of a clinical trial volunteer; searching and collecting the clinical trial volunteer recruitment notice announced by the clinical research institute; and classifying the collected clinical trial volunteer recruitment notice. And generating and storing the basic digital questionnaire corresponding to the clinical trial volunteer recruitment information, and providing the clinical trial volunteer recruitment announcement and the basic digital questionnaire to the clinical trial volunteer terminal.
- the basic digital provided to the test volunteer terminal Generating a clinical trial volunteer questionnaire according to the information inputted from the questionnaire and transmitted from the clinical trial volunteer terminal, and comparing the basic digital questionnaire information and the clinical trial volunteer questionnaire information to determine eligibility or ineligibility of the clinical trial subject Between the clinical trial volunteer and the clinical trial management institution, comprising: informing the clinical volunteer volunteer terminal whether the clinical trial candidate is eligible or ineligible; and providing the clinical trial volunteer questionnaire information to the primary clinical research institute. Provide clinical information matching method.
- the collected clinical trial volunteer recruitment notification may be classified by disease name, medical department, body part, and region to generate the clinical trial volunteer recruitment information.
- the method may further include generating an additional digital questionnaire requested by the clinical trial management institution and providing it to the qualified volunteer terminal.
- said additional digital questionnaire may comprise a short answer questionnaire.
- the method may further include transmitting the interview request information requested from the clinical trial management institution to the qualified volunteer terminal.
- the method may further include translating and providing a domestic clinical trial information provided in a foreign language to a foreign clinical trial information site in a Korean language.
- the clinical trial volunteer questionnaire may be analyzed to further filter the clinical trial overlap support within a specific period of time to further determine the eligibility or ineligibility of the clinical trial subject.
- the method may further include the step of receiving registration and management of clinical trial subject medical institution information and clinical trial volunteer recruitment information from the clinical trial subject medical institution.
- the trial volunteer information for the specific clinical trial is first received and stored from the clinical trial volunteer terminal, and subsequently, the clinical trial administration
- the clinical trial volunteer recruitment notice for the specific clinical trial is registered from a medical institution
- the clinical trial volunteer recruitment notification is notified to the clinical trial volunteer terminal, and the clinical trial volunteer information received in advance transmits the specific clinical trial registration notification. It may include a period of validity information, and further comprising the step of notifying the clinical volunteer volunteer terminal whether the extension of the validity of the specific clinical trial registration notification at the end of the validity period and to stop or extend the registration notification for this; have.
- the present invention by collecting the clinical trial volunteer recruitment announcement announced by the pharmaceutical company, each medical organization, medical institution or clinical trial conducting institution to digitally match the basic digital questionnaire information required for the clinical trial and the corresponding clinical trial volunteer questionnaire information Afterwards, the most appropriate clinical trial volunteers for the clinical trial can be easily selected as qualified and ineligible candidates, and among the qualified persons, the overlapping clinical trial volunteers are filtered within a specific period of time, and the personnel involved in the recruitment of clinical trial volunteers and the clinical trial process. And by reducing the cost significantly, there is an effect that can contribute to the health promotion of the clinical trial volunteers.
- 1A is a schematic flowchart of a method for matching clinical trial information between a clinical trial volunteer and a clinical trial supervising medical institution according to a preferred embodiment of the present invention.
- FIG. 1B is a schematic flowchart of an unregistered clinical trial processing step of the clinical trial information matching method of FIG. 1A.
- 1A is a schematic flowchart of a method for matching clinical trial information between a clinical trial volunteer and a clinical trial supervising medical institution according to a preferred embodiment of the present invention.
- the clinical trial volunteer terminal 100 receives and installs the clinical trial support app from the clinical trial information integration server 200 (S110).
- the basic personal information and body information of the clinical trial volunteer are received and stored 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 clinical trial subject medical institution 300 that is, the search for the clinical trial volunteers announced from the pharmaceutical company, each medical group, medical institution or clinical trial conduct online search and collect the DB (not shown) Store in
- the collected and stored clinical trial volunteers are classified, and the collected clinical trial volunteers are classified into disease names, medical departments, body parts, and regions (by clinical trial subject medical institution location). Recruitment announcement information can be generated.
- cancer detailed 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
- family medicine internal medicine (in detail, infectious medicine, endocrine medicine, endocrine metabolism or rheumatology), surgery, neurology, anesthetic pain medicine, urology, radiation oncology, gynecology, radiology, ophthalmology, otolaryngology, rehabilitation medicine , Head / face (eyes, ears, nose, teeth, oral cavity, tongue, gums or jaw), neck / chest, abdomen, pelvis or arm /, by treatments such as mental health medicine, dentistry, dermatology, pediatric adolescents or clinical pharmacology.
- body parts such as legs, it can be classified to generate recruitment information for clinical trial volunteers.
- a basic digital questionnaire table for questioning the necessary items comprehensively corresponding to the clinical trial volunteer recruitment announcement information generated above is generated and stored.
- the basic digital questionnaire is a pre-test questionnaire, and includes gender, age (date of birth), local information (volunteer address), weight, height, BMI index according to weight and height, blood type information, participation in clinical trials, and recent specific period ( For example, within the last three months), multiple-choice questions about whether or not you have participated in clinical trials, or whether smoking and drinking, and how much and how much you smoke.
- the detailed clinical trial volunteer recruitment announcement and basic digital questionnaire provided by the clinical trial supervising medical institution 300 are classified by disease name, medical department, body part, and region. 100) can be provided in the form of clinical trial support app, but can also be provided in the form of web services.
- the clinical trial volunteer questionnaire is generated 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. do.
- the basic digital questionnaire information and the clinical trial volunteer questionnaire information are compared to determine whether the clinical trial volunteer is eligible or ineligible for the clinical trial volunteer suitable for the clinical trial request.
- the basic digital questionnaire information includes information on qualified or ineligible conditions for basic essential items that are comprehensively applicable to the clinical trial.
- the determination step (S270) by analyzing the clinical trial volunteer questionnaire to filter (screen) whether or not overlapping clinical trial support within a specific period of time, it is possible to further determine the eligibility or ineligibility of the clinical trial subjects.
- the clinical trial volunteer terminal 100 to promptly send by SNS, text or e-mail whether the clinical trial subjects qualified or ineligible.
- the qualifying questionnaire providing step (S280) the qualified clinical trial volunteer questionnaire information is sent to SNS, text or e-mail to the clinical investigation subject medical institution 300 is provided quickly.
- interview request information transmitting step S291 may be further performed to transmit the interview request information requested from the clinical trial administration medical institution 300 to the qualified volunteer terminal 100.
- the call center for the subsequent services to the clinical trial volunteers and the clinical trial host medical institution may be on behalf of the processing of the work.
- an additional digital questionnaire providing step (S292) may be further provided to generate an additional digital questionnaire requested by the clinical trial administration medical institution 300 and provide it to the eligible volunteer terminal 100.
- the additional digital questionnaire providing step (S292) it is possible to provide an additional digital questionnaire including an additional or detailed subjective questionnaire according to the request of the clinical trial supervisor.
- the basic digital questionnaire can quickly filter clinical trial volunteers to basic or standard questionnaire information that is comprehensively applied to clinical trials with low or low frequency of registration, thus preventing duplication of clinical trial volunteers within a specific period of time. Participation can be prevented, 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.
- it may further include a translation step (S293) for translating the domestic clinical trial information provided in a foreign language to the overseas clinical trial information site in Korean.
- the clinical trial information should be announced to the Korea Food and Drug Administration or related overseas site according to the clinical trial disclosure principle.
- the clinical trial volunteer terminal 100.
- the clinical trial subject medical institution 300 may further include a registration and management step (S294) of directly receiving and registering the clinical trial subject medical institution information and clinical trial volunteer recruitment information without separate collection steps.
- FIG. 1B is a schematic flowchart of an unregistered clinical trial processing step of the clinical trial information matching method of FIG. 1A.
- a clinical trial volunteer for a specific clinical trial from the clinical trial volunteer terminal 100.
- S295-2 To notify and to stop or extend the registration notification (S295-2).
- the clinical trial information integration server 200 receives the clinical trial volunteer information from the clinical trial volunteer terminal 100 in advance for a rare disease or a desired clinical trial having a very low frequency of clinical trial volunteer notification.
- the clinical trial volunteer recruitment announcement for the rare disease or desired clinical trial described above is registered from the clinical institution administering the clinical trial 300, the clinical trial information integrated server 200 is the clinical trial volunteer terminal 100
- SNS Session Initiation Service
- S295-1 Session 1
- the clinical trial volunteer information received in advance includes information on the validity period of a specific clinical trial registration notification, and the clinical trial information integration server 200 determines whether to extend the validity period of the specific clinical trial registration notification at the end of the validity period. It may be transmitted to the volunteer terminal 100 and the corresponding registration notification may be stopped or extended (S295-2).
- the restriction on access to the clinical trial information limited by the clinical trial supervising medical institution or region is eliminated, and a significant number of clinical trial volunteers' inquiries about eligibility for clinical trials are significantly increased. Reduce the efficiency of related tasks and implement correct medical ethics with transparent clinical trial volunteer information management.
- bioequivalence test may further include the steps of collecting, classifying, generating, storing, providing, selecting, judging and informing the bioequivalence test.
- 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 recruitment announcement of clinical trial volunteers announced by pharmaceutical companies, medical organizations, medical institutions or clinical trial institutes, and digitalizes the basic digital questionnaire information required for the clinical trial and the corresponding clinical trial volunteer questionnaire information.
- the human resources and costs involved in recruiting the clinical trial volunteers and proceeding of the clinical trial Significant savings can be made to contribute to the health promotion of clinical trial volunteers, eliminating the restriction of clinical trial volunteers' access to clinical trial information limited by the clinical institution or region.
- Clinical trial eligibility It can significantly reduce improve work efficiency, and transparency and it is industrially very useful as it can implement the preferred medical ethics in the right clinical trial volunteers information management.
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- General Health & Medical Sciences (AREA)
- Medical Informatics (AREA)
- Primary Health Care (AREA)
- Public Health (AREA)
- Medical Treatment And Welfare Office Work (AREA)
Abstract
La présente invention concerne un procédé de mise en correspondance d'informations d'essai clinique entre des volontaires d'essai clinique et une institution médicale effectuant un essai clinique, comprenant les étapes suivantes : un serveur d'intégration d'informations d'essai clinique collecte et catégorise des avis de recrutement de volontaires d'essai clinique; un graphique d'examen médical numérique de base est généré et fourni à un terminal des volontaires d'essai clinique; des graphiques d'examen médical éligibles parmi des graphiques d'examen médical des volontaires d'essai clinique sont comparés et déterminés et une éligibilité est notifiée par l'intermédiaire du terminal des volontaires d'essai clinique. Il en résulte que la limitation de l'accès à des informations d'essai clinique, qui est limitée par des institutions médicales effectuant un essai clinique ou par région, peut être résolue, l'efficacité de travail peut être augmentée en réduisant de manière significative les appels d'interrogation excessifs effectués par des volontaires d'essai clinique concernant l'éligibilité d'essai clinique, et des éthiques médicales appropriés peuvent être observées en gérant de manière transparente des informations de volontaires d'essai clinique.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR20170046913 | 2017-04-11 | ||
| KR10-2017-0046913 | 2017-04-11 | ||
| KR10-2017-0086257 | 2017-07-07 | ||
| KR1020170086257A KR20180133301A (ko) | 2017-04-11 | 2017-07-07 | 임상시험 자원자와 임상시험 주관의료기관 간의 임상시험정보 매칭 방법 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2018190479A1 true WO2018190479A1 (fr) | 2018-10-18 |
Family
ID=63793264
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/KR2017/012104 WO2018190479A1 (fr) | 2017-04-11 | 2017-10-30 | Procédé de mise en correspondance d'informations d'essai clinique entre des volontaires d'essai clinique et une institution médicale effectuant un essai clinique |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2018190479A1 (fr) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110209107A (zh) * | 2019-05-10 | 2019-09-06 | 宁波安信数控技术有限公司 | 一种通过dtu远程调试plc设备的方法及系统 |
Citations (5)
| 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 |
-
2017
- 2017-10-30 WO PCT/KR2017/012104 patent/WO2018190479A1/fr active Application Filing
Patent Citations (5)
| 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 |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110209107A (zh) * | 2019-05-10 | 2019-09-06 | 宁波安信数控技术有限公司 | 一种通过dtu远程调试plc设备的方法及系统 |
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