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International Clinical Trials

Making a Comeback

Over the past three years, Indian regulatory authorities have made a concerted effort to overhaul the study approval process and rewrite the policies governing how trials are conducted. Revisions are ongoing, but already many of the issues that sponsors considered as hindrances have either been completely removed or largely mitigated. Trial activity has, subsequently, begun to increase, with the pace of approvals picking up over the course of 2015. But what made sponsors consider India in the first place?

Key Advantages

Several characteristics make the Indian population attractive from a research perspective:
  • Concentration in urban centres: according to the 2011 census, 31% of India’s population lives in urban centres, compared to 18% in 1961. Although this is less than that of the other fast-growing economies of Brazil, Russia and China, the trend is clear. The McKinsey Global Institute projects that between 2008 and 2030, the country’s urban population will skyrocket from 340 to 590 million (1). This concentration greatly adds to the ease with which patients can be recruited and monitored during clinical trials
  • Ethnic diversity: India “has served as a major corridor for the dispersal of modern humans”, with multiple migratory waves during prehistoric and historic times (2,3). Today, the country is an amalgam of at least six ethnic groups (Negrito, Proto, Mongoloids, Mediterranean or Dravidian, Western Brachycephals and Nordic Aryans/Caucasians). This diversity provides sponsors with the opportunity to collect data across various genetic patterns. In fact, the Ministry of Health (MoH) requires sponsors to conduct trials across four regions of India. “The centres should be in different geographical areas of the country so that patients of different ethnic origins can be exposed to the drug. The results of the study determine the efficacy and side effects of the drug being evaluated, and may also shed some light on compliance” (4)
  • Broad age range: the vast majority of Indians (64%) are between 15 and 64 years old – the very demographic that is most commonly included in clinical trials
  • High unmet medical need
The average life expectancy in India is 69-70 years, and there is a high prevalence of both acute and chronic diseases as lifestyle-related disorders are on the rise. In total, India represents 16% of the world’s population, but bears 20% of the global disease burden.

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Thanuja Naidu has been with Pharm- Olam since 2006, and is the Country Head and Operations Manager for the company’s India office. She has been working in clinical research for over 20 years and uses her expertise and native knowledge of the Indian clinical research environment for each of her projects, leading the clinical operations and regulatory teams on the ground.
Thanuja Naidu
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