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5 October 2012
Transferring the authority to monitor national clinical trial registry to FDA will enhance the power of FDA and in addition the transparency for clinical trials through proposed TEST Act extends to include trial sites outside US while registering a trial1. These are quite appropriate steps in view of the OIG report of DHHS, USA listing developing countries as new destinations for many clinical trials2. This would certainly help the health experts in publishing systematic reviews and journal editors in reviewing manuscripts3. The overhaul of regulations involving humans in clinical research is being undertaken in US but there is another related issue of watching the ethics committees (ECs) in protection of human subjects4. These changes become significant especially since October 2008 revision of Declaration of Helsinki (DOH) as FDA chose to favor Good Clinical Practice instead of DOH as ethical standard for granting licenses to market new drugs5. Although DOH revision includes disclosure of research design in clinical trial registries but finer ethical issues like recruitment and consent process remain difficult to be reported in registry of clinical trials. This may not be sufficient for human subject protection and variability in ethics review procedures in developing countries may be more pronounced than the countries who actually designed the GCP namely USA, Europe and Japan.
Further, the situation in developing countries is plagued by poor implementation of ethics6 and the lack of awareness on regulatory processes especially related to ethics review as many institutions having no ethics committee had been revealed in a report from Clinical Trial Registry of India7. In such a situation clinical trial registrations at Clinical Trial.gov could allow FDA, through monitoring and inspections, to protect the human subjects from developing countries also but strengthening of the ethics would be most desirable in developing countries at the local level.
1. Drazen JM. Transparency for clinical trials- the TEST Act. N Eng J Med 2012; 367:863-4.
2. Challenges to FDA's Ability To Monitor and Inspect Foreign Clinical Trials http://oig.hhs.gov/oei/reports/oei-01-08-00510.pdf (2010)
3. Marshall E. Unseen World of Clinical Trials emerges from US Database. Science 2011; 333:145.
4. Who watches the watchmen? Nature 2011; 476:125.
5. Kimmelman J, Weijer C, Meslin M, Helsinki Discords: FDA, ethics, and international drug trials. Lancet 2009;373:13-4
6. Shetty, P. Vaccine trial’s ethics criticized. Nature 2011; 474: 427-8
7. Pandey A., Agarwal A R, Moulik M et al. Clinical Trial Registry-India: Raising the veil. Nat Med J Ind (2010) 23(3) 187-8.
Competing interests: None declared
CSIR-Central Drug Research Institute, Lucknow, India, CSIR-Central Drug Research Institute, Lucknow, India
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