Wednesday, 26 October 2011

Ethical Obligations in Clinical Drug Trials

As the medical research world becomes increasingly globalised, there is a need to make research methodologically valid, and to observe the highest standard of ethics. An increasing number of pharmaceutical companies have started outsourcing drug trials to Contract Research Organizations (CROs) in developing countries; these now make up a specialized global industry focusing on research on human participants. Shifts in the very science of drug development have influenced the decision to increase participant recruitment, with India becoming an attractive destination for international, outsourced clinical trials.

Revealingly, in India, debates over the conduct of drug trials by CROs, research institutions, pharmaceutical industries, international health NGOs, and the State are emerging. Indian sites for the research are without any independent institutions for monitoring and auditing of drug trials. In the absence of such a mechanism, it is difficult to ensure that scientific standards are upheld, and that good research practices and mandated trial protocols are fulfilled. Eventually, the quality, practice, ethics and effectiveness of science itself may be compromised.

Currently, the infrastructure for regulation, ethics review and monitoring is insufficient to regulate clinical trials in the country. In this situation, the government’s push to encourage clinical trials in India must be viewed with concern. There are many examples of drug trials that have taken place without proper protocols of consent. Without adequate and necessary regulatory jurisdiction or systematic review, the reliability and validity of such research is jeopardized. Considerations of transparency along with protection of participant rights have to be made priority for policy that truly engages and respects the public. This is particularly critical in the context of medicine and vaccine trials, placebo-based trials and genetic studies that are often in violation of both, the Declaration of Helsinki as well as the guidelines for biomedical research as laid out by the Indian Council of Medical Research (ICMR). India requires more substantial regulation, and effective implementation, that can institutionalise the highest standards of independent inquiry, good clinical practice, protocols, monitoring, and follow up, so that a strong and pro-people policy framework can be put in place.

Jananeethi Institute has taken up this project for ensuring the clinical drug trials in Kerala ethically sound and corruption-free under the banner of Citizens Against Corruption sponsored by Partnership for Transparency Fund based in Washington facilitated by Public Affairs Centre in Bangalore.

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