Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Desai, BS, Dixit, AS, Gota, VS
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer - Medknow 2019
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
_version_ 1783418151758725120
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
work_keys_str_mv AT desaibs centralinstitutionalethicscommitteeneededtofacilitatetimelyreviewofmulticenterclinicaltrials
AT dixitas centralinstitutionalethicscommitteeneededtofacilitatetimelyreviewofmulticenterclinicaltrials
AT gotavs centralinstitutionalethicscommitteeneededtofacilitatetimelyreviewofmulticenterclinicaltrials