Clinical Research Environment in India: Challenges and Proposed Solutions.

Area of Science:

• Clinical research
• Regulatory affairs
• Public health policy

Background:

• India has a significant need and desire for indigenous clinical research.
• Despite previous growth, the sector's expansion has not met expectations.
• Clinical trial growth in India has shown a significant contraction since 2010.

Purpose of the Study:

• To review progress and impediments in India's clinical research sector.
• To identify challenges affecting clinical trial expansion in India.
• To propose targeted solutions for the identified challenges.

Main Methods:

• Review of scientific literature, lay press reports, and ClinicalTrials.gov data.
• Analysis of compound annual growth rates (CAGR) for clinical trial phases (1, 2, and 3).
• Identification of factors influencing clinical trial sector performance.

Main Results:

• The Indian clinical trial sector experienced a CAGR contraction of -14.6% between 2010 and 2013.
• Phase 2 and Phase 3 trials showed significant contraction after 2009-2010.
• Key challenges include regulatory process slowdowns, increased media/activist engagement, and evolving guidelines.

Conclusions:

• The clinical research sector in India has contracted after a 2009-2010 peak.
• Challenges exist in regulatory enforcement, professional training, and public awareness.
• Recommendations include regulatory overhaul, enhanced education, and public empowerment.