Abstract
Like other emerging economies, India's quest for independent, evidence-based, and affordable healthcare has led to robust and promising growth in the clinical research sector, with a compound annual growth rate (CAGR) of 20.4% between 2005 and 2010. However, while the fundamental drivers and strengths are still strong, the past few years witnessed a declining trend (CAGR -16.7%) amid regulatory concerns, activist protests, and sponsor departure. And although India accounts for 17.5% of the world's population, it currently conducts only 1% of clinical trials. Indian and international experts and public stakeholders gathered for a 2-day conference in June 2013 in New Delhi to discuss the challenges facing clinical research in India and to explore solutions. The main themes discussed were ethical standards, regulatory oversight, and partnerships with public stakeholders. The meeting was a collaboration of AAHRPP (Association for the Accreditation of Human Research Protection Programs)-aimed at establishing responsible and ethical clinical research standards-and PARTAKE (Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment)-aimed at informing and engaging the public in clinical research. The present article covers recent clinical research developments in India as well as associated expectations, challenges, and suggestions for future directions. AAHRPP and PARTAKE provide etiologically based solutions to protect, inform, and engage the public and medical research sponsors.
Highlights
In June 2013, a group of local and international clinical research and public stakeholders gathered in New Delhi to tackle a unique challenge: the fortunes and prospects of clinical research in India, one of the most promising global clinical research environments, appeared to be in decline
The meeting was a collaboration of AAHRPP (Association for the Accreditation of Human Research Protection Programs)—aimed at establishing responsible and ethical clinical research standards—and PARTAKE (Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment)—aimed at informing and engaging the public in clinical research
On January 30, 2013, the Ministry of Health and Family Welfare of India issued an amendment to the Drugs and Cosmetics Act of 1940 and the Ministry of Law issued a set of guidelines on patient compensation that included the need to pay should an experimental drug fail to show the intended therapeutic benefit (Table 2) [25,30], Human Research Protection Program (HRPP) Conference, June 29–30, 2013, New Delhi, India]
Summary
In June 2013, a group of local and international clinical research and public stakeholders gathered in New Delhi to tackle a unique challenge: the fortunes and prospects of clinical research in India, one of the most promising global clinical research environments, appeared to be in decline. Conference stakeholders included experts from industry, academia, regulatory bodies, and the private sector as well as representatives from patient advocacy and public activist groups, nongovernmental organizations (NGO’s), and the media. The scope of the representation was a reflection of the organizers’ collective belief that medical research in general and clinical research in particular require collaboration of both professional and non-professional segments of society, a rare undertaking in usual practice, to understand the challenges facing the sector and to identify effective solutions
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