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An overview of primary registries of WHO's international clinical trial registry platform

INTRODUCTION: WHO's International Clinical Trials Registry Platform (ICTRP) has 17 primary registries that collect the information on the minimum set of items of trial information that appear in the register and these registries are also endorsed by the International Committee of Medical Journa...

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Autores principales: Juneja, Atul, Gupta, Jyotsna, Yadav, Neha, Sharma, Saurabh, Panchal, Yashmin, Adhikari, Tulsi, Rao, M. Vishnu Vardhana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer - Medknow 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7685261/
https://www.ncbi.nlm.nih.gov/pubmed/33281389
http://dx.doi.org/10.4103/ayu.AYU_62_20
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author Juneja, Atul
Gupta, Jyotsna
Yadav, Neha
Sharma, Saurabh
Panchal, Yashmin
Adhikari, Tulsi
Rao, M. Vishnu Vardhana
author_facet Juneja, Atul
Gupta, Jyotsna
Yadav, Neha
Sharma, Saurabh
Panchal, Yashmin
Adhikari, Tulsi
Rao, M. Vishnu Vardhana
author_sort Juneja, Atul
collection PubMed
description INTRODUCTION: WHO's International Clinical Trials Registry Platform (ICTRP) has 17 primary registries that collect the information on the minimum set of items of trial information that appear in the register and these registries are also endorsed by the International Committee of Medical Journal Editors. OBJECTIVE: The objective of this study is to describe the profile of all the primary registries including Clinical Trial Registry‑India (CTRI), through features such as magnitude, domain of registration, flagging, audit trail, language, mandatory requirements, and result disclosure. METHODOLOGY: The profiling of all registries was based on countries and zones, year of establishment, registrant, flagging, conflict of interest, language, documents, result disclosure, type of study, mode of registration, mandate of registration, quality check method, individual patient data statement and translation of content facility. The mode of search used was online which included advanced search, basic search and also from the audio/video manual on their website. RESULTS: There are 17 primary registries of ICTRP, the first one International Standard Randomised Controlled Trial Number (ISRCTN) of England being initiated in year 2000 and the most recent being Lebanese registry, in September 2019. The trials registered with these registries range from 301 in Cuba to 53972 in European union's EU Clinical Trials Register. The primary registries in WHO registry network are diverse in functionalities and practices. The characteristics of online registers vary in content and features and to achieve coordinated level of data quality, across all the different registries and to keep a balance in standards of the data collected and validation of that data, the registries are adhering to the minimum data set items laid down by ICTRP. CONCLUSION: The very process of registering the clinical studies helps in promoting the research methods and also raising the standards of research, especially among young researchers. It also helps in reducing the duplicity of research.
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spelling pubmed-76852612020-12-03 An overview of primary registries of WHO's international clinical trial registry platform Juneja, Atul Gupta, Jyotsna Yadav, Neha Sharma, Saurabh Panchal, Yashmin Adhikari, Tulsi Rao, M. Vishnu Vardhana Ayu Invited Article INTRODUCTION: WHO's International Clinical Trials Registry Platform (ICTRP) has 17 primary registries that collect the information on the minimum set of items of trial information that appear in the register and these registries are also endorsed by the International Committee of Medical Journal Editors. OBJECTIVE: The objective of this study is to describe the profile of all the primary registries including Clinical Trial Registry‑India (CTRI), through features such as magnitude, domain of registration, flagging, audit trail, language, mandatory requirements, and result disclosure. METHODOLOGY: The profiling of all registries was based on countries and zones, year of establishment, registrant, flagging, conflict of interest, language, documents, result disclosure, type of study, mode of registration, mandate of registration, quality check method, individual patient data statement and translation of content facility. The mode of search used was online which included advanced search, basic search and also from the audio/video manual on their website. RESULTS: There are 17 primary registries of ICTRP, the first one International Standard Randomised Controlled Trial Number (ISRCTN) of England being initiated in year 2000 and the most recent being Lebanese registry, in September 2019. The trials registered with these registries range from 301 in Cuba to 53972 in European union's EU Clinical Trials Register. The primary registries in WHO registry network are diverse in functionalities and practices. The characteristics of online registers vary in content and features and to achieve coordinated level of data quality, across all the different registries and to keep a balance in standards of the data collected and validation of that data, the registries are adhering to the minimum data set items laid down by ICTRP. CONCLUSION: The very process of registering the clinical studies helps in promoting the research methods and also raising the standards of research, especially among young researchers. It also helps in reducing the duplicity of research. Wolters Kluwer - Medknow 2019 2020-08-08 /pmc/articles/PMC7685261/ /pubmed/33281389 http://dx.doi.org/10.4103/ayu.AYU_62_20 Text en Copyright: © 2020 AYU (An International Quarterly Journal of Research in Ayurveda) http://creativecommons.org/licenses/by-nc-sa/4.0 This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.
spellingShingle Invited Article
Juneja, Atul
Gupta, Jyotsna
Yadav, Neha
Sharma, Saurabh
Panchal, Yashmin
Adhikari, Tulsi
Rao, M. Vishnu Vardhana
An overview of primary registries of WHO's international clinical trial registry platform
title An overview of primary registries of WHO's international clinical trial registry platform
title_full An overview of primary registries of WHO's international clinical trial registry platform
title_fullStr An overview of primary registries of WHO's international clinical trial registry platform
title_full_unstemmed An overview of primary registries of WHO's international clinical trial registry platform
title_short An overview of primary registries of WHO's international clinical trial registry platform
title_sort overview of primary registries of who's international clinical trial registry platform
topic Invited Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7685261/
https://www.ncbi.nlm.nih.gov/pubmed/33281389
http://dx.doi.org/10.4103/ayu.AYU_62_20
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