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J Postgrad Med. 2019 Apr-Jun;65(2):107-109. doi: 10.4103/jpgm.JPGM_428_18.

Central institutional ethics committee needed to facilitate timely review of multicenter clinical trials.

Author information

1
Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Navi Mumbai, Maharashtra, India.

Abstract

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.

KEYWORDS:

Central ethics committee; Institutional ethics committee; multicenter review

PMID:
30924443
DOI:
10.4103/jpgm.JPGM_428_18
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