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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...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Medknow Publications & Media Pvt Ltd
2013
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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. |
format | Online Article Text |
id | pubmed-3877534 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | Medknow Publications & Media Pvt Ltd |
record_format | MEDLINE/PubMed |
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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