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Registration of Clinical Trials: Is it Really Needed?

BACKGROUND AND AIMS: Withholding findings of clinical trials for publication or presentation to the regulatory authorities is a major concern. We aimed to address the importance of clinical trial registration and whether it is needed or not. DISCUSSION: For ethical conduct of clinical trial, registr...

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Autores principales: Aslam, Ameer, Imanullah, Sameera, Asim, Mohammad, El-Menyar, Ayman
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3877534/
https://www.ncbi.nlm.nih.gov/pubmed/24404555
http://dx.doi.org/10.4103/1947-2714.123266
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author Aslam, Ameer
Imanullah, Sameera
Asim, Mohammad
El-Menyar, Ayman
author_facet Aslam, Ameer
Imanullah, Sameera
Asim, Mohammad
El-Menyar, Ayman
author_sort Aslam, Ameer
collection PubMed
description BACKGROUND AND AIMS: Withholding findings of clinical trials for publication or presentation to the regulatory authorities is a major concern. We aimed to address the importance of clinical trial registration and whether it is needed or not. DISCUSSION: For ethical conduct of clinical trial, registration is an important but debatable issue due to proprietary interest of the pharmaceutical industry. Over the years, investigating agencies uncovered several instances of misconduct during the clinical trial. The International committee of medical journal editors requires registration of trial methodology, but does not require registration of trial results; however, the U.S. Food and Drug Administration Amendments does require researchers to register results. CONCLUSION: Prospective registration of clinical trial is mandatory for more transparent research and sustaining the validity of evidence based practice and availability of reliable data. Clinical trials registration has the potential to contribute substantially to improve clinical trial transparency and reducing publication bias and selective reporting.
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spelling pubmed-38775342014-01-08 Registration of Clinical Trials: Is it Really Needed? Aslam, Ameer Imanullah, Sameera Asim, Mohammad El-Menyar, Ayman N Am J Med Sci Debates Article BACKGROUND AND AIMS: Withholding findings of clinical trials for publication or presentation to the regulatory authorities is a major concern. We aimed to address the importance of clinical trial registration and whether it is needed or not. DISCUSSION: For ethical conduct of clinical trial, registration is an important but debatable issue due to proprietary interest of the pharmaceutical industry. Over the years, investigating agencies uncovered several instances of misconduct during the clinical trial. The International committee of medical journal editors requires registration of trial methodology, but does not require registration of trial results; however, the U.S. Food and Drug Administration Amendments does require researchers to register results. CONCLUSION: Prospective registration of clinical trial is mandatory for more transparent research and sustaining the validity of evidence based practice and availability of reliable data. Clinical trials registration has the potential to contribute substantially to improve clinical trial transparency and reducing publication bias and selective reporting. Medknow Publications & Media Pvt Ltd 2013-12 /pmc/articles/PMC3877534/ /pubmed/24404555 http://dx.doi.org/10.4103/1947-2714.123266 Text en Copyright: © North American Journal of Medical Sciences http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Debates Article
Aslam, Ameer
Imanullah, Sameera
Asim, Mohammad
El-Menyar, Ayman
Registration of Clinical Trials: Is it Really Needed?
title Registration of Clinical Trials: Is it Really Needed?
title_full Registration of Clinical Trials: Is it Really Needed?
title_fullStr Registration of Clinical Trials: Is it Really Needed?
title_full_unstemmed Registration of Clinical Trials: Is it Really Needed?
title_short Registration of Clinical Trials: Is it Really Needed?
title_sort registration of clinical trials: is it really needed?
topic Debates Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3877534/
https://www.ncbi.nlm.nih.gov/pubmed/24404555
http://dx.doi.org/10.4103/1947-2714.123266
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