The Role of Accreditation in an Emerging Market

With its favorable business climate, sizable treatment-naive population, and large number of English-speaking professionals, India is one of the most promising emerging markets for clinical trials. But as the volume of trials has increased, so have reports of abuses and concerns about inadequate protections for research participants.

Public outcry is on the rise, and there are calls for increased government regulation. In response, some are taking the lead and turning to the same organization that helped resolve similar issues in the West: AAHRPP.

Last month, two hospitals—Kasturba Hospital, Manipal and Manipal Hospital, Bangalore—became the first institutions in India to attain AAHRPP accreditation. In keeping with AAHRPP standards for accreditation of non-U.S. organizations, the hospitals met their own nation's requirements as well as those of the United States.

Officials at both hospitals say their decision to seek accreditation was based primarily on AAHRPP’s emphasis on quality and track record of building public trust.

“Prospective participants and the public in general are looking to the research enterprise to take responsibility for ensuring that research is conducted safely and ethically,” says K. Laxminarayana Bairy, M.D., Ph.D., director of the Manipal Centre for Clinical Research at Kasturba Hospital. “AAHRPP accreditation offers assurances that we comply with the highest standards and are committed to quality research.”

Pratibha Pereira, M.D., head of the Department of Clinical Research at Manipal Hospital, agrees. “Accreditation demonstrates that we have the systems in place not only to protect research participants but also to advance research more efficiently and effectively,” she says. “That helps build public trust and confidence―in India and around the world.”

India’s appeal as a hub for clinical trials rests, in part, with its demographics. With nearly 1.2 billion people, India ranks second only to China in total population. Much of India’s population is clustered in urban areas, making it easy and inexpensive to identify and enroll participants in clinical trials. In addition, more than 70 percent of India’s population is classified as being similar in ethnicity to Western peoples, so research results have broad application.

Another advantage is the absence of a language barrier. English enjoys the status of “subsidiary official language” and is widely considered the preferred language for commercial communications. And the Indian government has embraced the international research enterprise.

Perhaps the greatest challenge has been ensuring adequate oversight in the face of double-digit growth in research trials. AAHRPP, with its emphasis on common, higher standards worldwide, can play a significant role in protecting participants in India and facilitating high-quality research that has the potential to benefit the public good.