Byline: B. Desai, A. Dixit, V. Gota
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.
We were approached by an Indian pharmaceutical company to conduct a bioequivalence study for liposomal doxorubicin, a complex generic formulation. The research protocol failed to receive a favorable decision from our hospital's Institutional Ethics Committee (IEC). Our IEC's decision certainly stood out in this regard because the study was approved by the Indian drug regulatory agency and the ethics committees of all participating centers. An appeal against this decision led to a series of correspondence between the IEC and PI, each interspersed by several weeks of review, and by the time the trial was eventually approved, it was too late to initiate the study. This brings us to wonder whether multicenter trials approved by Drug Controller General of India (DCGI) should only undergo IEC review for specific local issues which are unique to the center, or should it be subjected to a comprehensive review. Alternatively, should a centralized ethics committee be made responsible to discuss and approve the study protocol on behalf of all the participating centers?
The function of ethical oversight of research involving human subjects is currently served by the IEC system, based on the prospective and ongoing local review of the proposed research. While clinical research has been around for decades, IECs are still evolving in India and other low and middle-income countries (LMICs). Along with each IEC facing challenges within itself, there is lack of harmonization among IECs operating at various institutions, leading to onerous duplication of efforts to achieve ethics approval for multicenter research. As multicenter clinical trials have become more common, it is pertinent to understand whether the goal of protecting research participants can be achieved by having a single comprehensive review by a...