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Central Institutional Ethics Committee needed to facilitate timely review of multicenter clinical trials
A multicenter trial in India undergoes review by Institutional Ethics Committees (IECs) of all participating institutions. The failure to obtain approval even from a single institution's IEC creates a situation of inequitable access to clinical trials. The dichotomy in decisions of different IE...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wolters Kluwer - Medknow
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6515773/ https://www.ncbi.nlm.nih.gov/pubmed/30924443 http://dx.doi.org/10.4103/jpgm.JPGM_428_18 |
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author | Desai, BS Dixit, AS Gota, VS |
author_facet | Desai, BS Dixit, AS Gota, VS |
author_sort | Desai, BS |
collection | PubMed |
description | A multicenter trial in India undergoes review by Institutional Ethics Committees (IECs) of all participating institutions. The failure to obtain approval even from a single institution's IEC creates a situation of inequitable access to clinical trials. The dichotomy in decisions of different IECs is attributed to lack of standardization and accountability in their functioning. The registration of IECs with Central Drugs Standard Control Organization notwithstanding, the current model of IEC review has failed to ensure uniformity in IEC decisions in multicenter trials. Alternative models that allow central review of multicenter clinical trials should be explored. |
format | Online Article Text |
id | pubmed-6515773 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Wolters Kluwer - Medknow |
record_format | MEDLINE/PubMed |
spelling | pubmed-65157732019-05-29 Central Institutional Ethics Committee needed to facilitate timely review of multicenter clinical trials Desai, BS Dixit, AS Gota, VS J Postgrad Med View Point A multicenter trial in India undergoes review by Institutional Ethics Committees (IECs) of all participating institutions. The failure to obtain approval even from a single institution's IEC creates a situation of inequitable access to clinical trials. The dichotomy in decisions of different IECs is attributed to lack of standardization and accountability in their functioning. The registration of IECs with Central Drugs Standard Control Organization notwithstanding, the current model of IEC review has failed to ensure uniformity in IEC decisions in multicenter trials. Alternative models that allow central review of multicenter clinical trials should be explored. Wolters Kluwer - Medknow 2019 /pmc/articles/PMC6515773/ /pubmed/30924443 http://dx.doi.org/10.4103/jpgm.JPGM_428_18 Text en Copyright: © 2019 Journal of Postgraduate Medicine 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 | View Point Desai, BS Dixit, AS Gota, VS Central Institutional Ethics Committee needed to facilitate timely review of multicenter clinical trials |
title | Central Institutional Ethics Committee needed to facilitate timely review of multicenter clinical trials |
title_full | Central Institutional Ethics Committee needed to facilitate timely review of multicenter clinical trials |
title_fullStr | Central Institutional Ethics Committee needed to facilitate timely review of multicenter clinical trials |
title_full_unstemmed | Central Institutional Ethics Committee needed to facilitate timely review of multicenter clinical trials |
title_short | Central Institutional Ethics Committee needed to facilitate timely review of multicenter clinical trials |
title_sort | central institutional ethics committee needed to facilitate timely review of multicenter clinical trials |
topic | View Point |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6515773/ https://www.ncbi.nlm.nih.gov/pubmed/30924443 http://dx.doi.org/10.4103/jpgm.JPGM_428_18 |
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