Trials and Travails

Since India relaxed its rules in 2005 to allow opening up of the clinical trial sector, there has been a surge of major pharmaceutical companies and Contract Research Organizations conducting trials in the country. India becomes an attractive destination because of low cost of conducting trials and perceived advantages in terms of ethnically diverse population, premier medical institutions and services on offer. Other advantages include its huge ‘treatment naive’ patient base and a supportive regulatory environment.

The clinical trial market in India is estimated to have reached US$2 billion annually in 2012. Debates over the conduct of clinical trials—by a diverse range of actors such as Clinical Research Organizations, research institutions, pharmaceutical industries, international health organisations and the State—have emerged of late. These highlight the need to make the entire process of clinical trials more transparent and accountable, and that there are various lose ends in the current framework because of which there have been many instances of violations in the principles and norms governing conduct of clinical trials as well as the functioning of regulatory authorities.

Particularly striking is the knowledge that is absent with respect to factors related to and surrounding human participation in clinical trials. Despite the large and exponential increase in enrolment of Indian participants in clinical trials, very little is known regarding their experiences and motivations, with practically no narrative on participants’ perspectives of recruitment patterns, protocols followed with regard to consent, compensation, adverse event reporting, monitoring systems, follow up, etc.

The study “Trails and Travails’ by Sama is pioneering, reflecting upon the perspectives of clinical trial subjects with a view towards strengthening advocacy and research for the health and rights of clinical trial participants.