Open AccessCentral Institutional Ethics Committee needed to facilitate timely review of multicenter clinical trials
Author(s) -
Bina Desai,
Amar Dixit,
V S Gota
Publication year - 2019
Publication title -
journal of postgraduate medicine/journal of postgraduate medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.405
H-Index - 52
eISSN - 0972-2823
pISSN - 0022-3859
DOI - 10.4103/jpgm.jpgm_428_18
Subject(s) - medicine , clinical trial , standardization , multicenter study , ethics committee , accountability , institution , multicenter trial , good clinical practice , institutional review board , medical physics , family medicine , intensive care medicine , randomized controlled trial , public administration , pathology , surgery , law , political science
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.