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WO2018190481A1 - Procédé de rendu d'informations d'essai clinique dans un format d'examen médical entre des volontaires d'essai clinique et une institution médicale effectuant un essai clinique - Google Patents

Procédé de rendu d'informations d'essai clinique dans un format d'examen médical entre des volontaires d'essai clinique et une institution médicale effectuant un essai clinique Download PDF

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Publication number
WO2018190481A1
WO2018190481A1 PCT/KR2017/012107 KR2017012107W WO2018190481A1 WO 2018190481 A1 WO2018190481 A1 WO 2018190481A1 KR 2017012107 W KR2017012107 W KR 2017012107W WO 2018190481 A1 WO2018190481 A1 WO 2018190481A1
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WO
WIPO (PCT)
Prior art keywords
clinical trial
information
questionnaire
volunteer
clinical
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Application number
PCT/KR2017/012107
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English (en)
Korean (ko)
Inventor
이병일
Original Assignee
주식회사 에이치비에이
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Priority claimed from KR1020170086259A external-priority patent/KR20180121765A/ko
Application filed by 주식회사 에이치비에이 filed Critical 주식회사 에이치비에이
Publication of WO2018190481A1 publication Critical patent/WO2018190481A1/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 a clinical trial information documenting technology, and more particularly, to a method of documenting 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 problems of the prior art, clinical trial volunteers and clinicians who can quickly screen the qualified or ineligible subjects by digitizing the questionnaire information and clinical trial volunteer questionnaire information required for clinical trials
  • the task is to provide a method for documenting the clinical trial information between the host medical institutions.
  • the clinical trial questionnaire integrated server receives the clinical trial volunteer recruitment information from the clinical trial host medical institution to generate a common standard questionnaire by disease name and medical department, body parts and regions And transmitting and posting the clinical trial purpose, content, and qualification of the clinical trial volunteer notification information from the clinical trial document integration server to the clinical trial volunteer terminal on which the clinical trial support app is installed, and the clinical trial Sending a questionnaire integrated server to the clinical trial volunteer terminal, basic clinical information, physical information, and basic questionnaire about participation in a clinical trial by the clinical trial volunteer terminal; Receive the information entered about the basic questionnaire And generating the clinical trial questionnaire integrated server by comparing the reference questionnaire and the pre-test questionnaire to determine whether the clinical trial is eligible, and storing the clinical trial questionnaire integrated server in a database. And notifying the clinical trial volunteer terminal, and transmitting the qualified clinical trial volunteer information and the pre-test questionnaire to the clinical trial administration medical institution by the clinical trial questionnaire integrated server. Provide a method for documenting clinical trial information between medical institutions.
  • the basic questionnaire is the blood type of the clinical trial volunteer, the past clinical trial participation experience, the participation in the clinical trial in the last three months, whether smoking, smoking, smoking, drinking, exercise, current disease, family history, drug Take-up, allergy / hypersensitivity, surgical experience, preference drink, hospital-supplied standard meals, and multiple-choice, short-term or multiple-choice questionnaire information about specific eating habits, and the reference questionnaire lists eligibility requirements for clinical trials.
  • Blood type of clinical trial volunteers according to disease name, medical department, body part and region, history of past clinical trial participation, participation in clinical trial in the last 3 months, smoking status, smoking volume, drinking status, drinking volume, exercise status, current illness, Family history, drug use, allergies / hypersensitivity, surgical experience, preference drink, standard meals provided by hospital And it may include paperweight information about the specific eating habits.
  • the method may further include transmitting the interview request information requested from the clinical study supervision medical institution to the qualified volunteer terminal.
  • the method may further include generating an additional questionnaire requested by the clinical study supervision medical institution and providing it to the qualified volunteer terminal.
  • the method may further include receiving the modified information received for the basic questionnaire from the clinical volunteer terminal and modifying the dictionary questionnaire.
  • the most suitable clinical trial volunteers can be quickly selected. This can significantly reduce the number of people and costs involved in the clinical trial process.
  • FIG. 1 is a schematic flowchart of a method for documenting clinical trial information between a clinical trial volunteer and a clinical trial administration medical institution according to a preferred embodiment of the present invention.
  • FIG. 2 illustrates the photographic paperweight of FIG. 1.
  • 3A to 3C illustrate the questionnaire information of FIG. 1 in detail.
  • FIG. 1 is a schematic flowchart of a method for documenting clinical trial information between a clinical trial volunteer and a clinical institution administering a clinical trial according to a preferred embodiment of the present invention.
  • FIG. 2 illustrates the photographic questionnaire of FIG. 1, and FIGS. 3A to 3C. Illustrates the paperweight information of FIG. 1 in detail.
  • a reference questionnaire generation step (S110), clinical trial volunteer recruitment information posting step ( S120), the basic questionnaire transmission step (S130), the preliminary questionnaire generation step (S140), clinical trial eligibility determination step (S150), clinical trial eligibility notification step (S160) and clinical trial subject medical institution transmission step (S170) do.
  • the clinical trial questionnaire integrated server 200 is notified of the recruitment of clinical trial volunteers from the clinical trial host medical institution (that is, pharmaceutical company, each medical group, medical institution or clinical trial conduct organization) (300)
  • the information is transmitted to generate a common standard questionnaire by disease name, medical department, body part, and region (see FIG. 3).
  • the reference questionnaire generation step (S110), cancer (detailed lung cancer, non-small cell lung cancer, adenocarcinoma, gastric cancer, breast cancer, rectal cancer, lymphoma or multiple myeloma), diabetes, arthritis, hepatitis, leukemia, hypertension, Alzheimer's disease, ulcer or asthma
  • family medicine internal medicine (in detail, infectious medicine, endocrine medicine, endocrine metabolism or rheumatology), surgery, neurology, anesthesia and pain medicine, urology, radiology, gynecology, radiology, ophthalmology, otolaryngology, Head / face (eyes, ears, nose, teeth, mouth, tongue, gums or jaw), neck / chest, abdomen, pelvis, or other departments such as rehabilitation, mental health, dentistry, dermatology, pediatric adolescents or clinical pharmacology
  • the body parts such as the arms / legs, it can be classified to generate the recruitment notification information of the clinical trial volunteers.
  • the clinical trial volunteer recruitment notification information from the clinical trial documentation integrated server 200 to the clinical trial volunteer terminal 100 installed clinical trial support app, Send and post content and eligibility requirements.
  • the clinical trial questionnaire integrated server 200 transmits the basic questionnaire information on the basic personal information, physical information and participation in the clinical trial of the clinical trial volunteer terminal 100 to the clinical trial volunteer terminal 100 do.
  • 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 (A, B, O or AB, and RH + or RH-), past clinical trial participation, past clinical trial participation in a specific time period or multiple choice questionnaire about smoking and drinking and smoking and drinking volume .
  • the clinical trial questionnaire integrated server 200 receives the information received for the basic questionnaire from the clinical trial volunteer terminal 100 to generate a pre-test questionnaire (see Figure 2).
  • receiving the modified information received for the basic questionnaire from the clinical trial volunteer terminal 100 may further comprise the step (S145) of modifying and generating a prior questionnaire.
  • the clinical trial questionnaire integrated server 200 determines the clinical trial eligibility by comparing the aforementioned standard questionnaire table and the pre-test questionnaire. In this case, it is necessary to clearly determine whether the clinical trial is eligible or ineligible by filtering (screening) overlapping clinical trial support within a specific period by comparing and analyzing the standard questionnaire and the pre-test questionnaire.
  • the basic questionnaire the blood type of the clinical trial volunteers, whether they have participated in past clinical trials, participation in clinical trials in the last three months, smoking, smoking, drinking, drinking, exercise, current illness, family history, drug use , Allergic / hypersensitivity, surgical experience, preference beverages, hospital provided standard meals and multiple choice (C), subjective (S) or multi-choice (M) questionnaire information for specific eating habits (Fig. 3a to Fig. 3c).
  • the clinical trial document integration integrated server 200 stores the eligibility in a database, and sends it to the clinical trial volunteer terminal 100 by SNS, text or e-mail promptly do.
  • the clinical trial documentization integrated server 200 quickly transmits the qualified clinical trial volunteer information and the pre-test questionnaire to the clinical trial subject medical institution 300 through SNS, text or e-mail. do.
  • the additional questionnaire may include a detailed questionnaire questionnaire.
  • the method may further include transmitting the interview request information requested from the clinical trial administration medical institution 300 to the qualified volunteer terminal 100 (S182).
  • the clinical trial volunteer questionnaire information required in the clinical trial conducted by a pharmaceutical company, each medical group, a medical institution, or a clinical trial institute is digitized by the configuration of the clinical trial information documenting method as described above. You can quickly select the clinical trial volunteers that are best suited for your needs.
  • the clinical trial support app is installed on the terminal, it can be equally applied to the clinical trial support service supported by the web service form, not the clinical trial support app.
  • 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 is a clinical trial through the method of questionnaire between the clinical trial volunteer and the clinical institution in charge of the clinical trial that can quickly select the subject eligible or ineligible by digitizing the questionnaire and the clinical trial volunteer information required for the clinical trial It is very useful industrially because it can quickly select the most appropriate clinical trial volunteers and significantly reduce the manpower and costs involved in the clinical trial process.

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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 rendu d'informations d'essai clinique dans un format d'examen médical entre des volontaires d'essai clinique et une institution médicale effectuant un essai clinique, comprenant les étapes consistant à : recevoir, en provenance de l'institution médicale effectuant un essai clinique, des informations de notification de recrutement de volontaire d'essai clinique et générer un tableau d'examen médical de référence ; transmettre et publier des informations de notification de recrutement de volontaire d'essai clinique en provenance d'un serveur d'intégration de rendu d'examen médical d'essai clinique vers un terminal d'un volontaire d'essai clinique sur lequel a été installée une application d'inscription à un essai clinique ; transmettre, au moyen du serveur d'intégration de rendu d'examen médical d'essai clinique, au terminal du volontaire d'essai clinique, un tableau d'examen médical de base comprenant des informations d'identification de base, des informations physiques et une décision de participation à l'essai clinique ; recevoir, au moyen du serveur d'intégration de rendu d'examen médical d'essai clinique, en provenance du terminal du volontaire d'essai clinique, des informations saisies concernant le tableau d'examen médical de base et générer un tableau d'examen médical de pré-visite ; comparer, au moyen du serveur d'intégration de rendu d'examen médical d'essai clinique, le tableau d'examen médical de base et le tableau d'examen médical de pré-visite et déterminer l'éligibilité pour l'essai clinique ; et notifier par l'intermédiaire du terminal du volontaire d'essai clinique, ce qui permet une sélection rapide de candidats optimaux pour l'essai clinique parmi les participants d'essai clinique éligibles en utilisant des informations de tableau d'examen médical numérisées.
PCT/KR2017/012107 2017-04-11 2017-10-30 Procédé de rendu d'informations d'essai clinique dans un format d'examen médical entre des volontaires d'essai clinique et une institution médicale effectuant un essai clinique WO2018190481A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
KR20170046919 2017-04-11
KR10-2017-0046919 2017-04-11
KR10-2017-0086259 2017-07-07
KR1020170086259A KR20180121765A (ko) 2017-04-11 2017-07-07 임상시험 자원자와 임상시험 주관의료기관 간의 임상시험정보 문진화 방법

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WO2018190481A1 true WO2018190481A1 (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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