title: Clinical Research Environment in India: Challenges and Proposed Solutions.
abstract: India has compelling need and keen aspirations for indigenous clinical research. Notwithstanding this need and previously reported growth the expected expansion of Indian clinical research has not materialized. We reviewed the scientific literature, lay press reports, and ClinicalTrials.gov data for information and commentary on projections, progress, and impediments associated with clinical trials in India. We also propose targeted solutions to identified challenges. The Indian clinical trial sector grew by (+) 20.3% CAGR (compound annual growth rate) between 2005 and 2010 and contracted by (-) 14.6% CAGR between 2010 and 2013. Phase-1 trials grew by (+) 43.5% CAGR from 2005-2013, phase-2 trials grew by (+) 19.8% CAGR from 2005-2009 and contracted by (-) 12.6% CAGR from 2009-2013, and phase-3 trials grew by (+) 13.0% CAGR from 2005-2010 and contracted by (-) 28.8% CAGR from 2010-2013. This was associated with a slowing of the regulatory approval process, increased media coverage and activist engagement, and accelerated development of regulatory guidelines and recuperative initiatives. We propose the following as potential targets for restorative interventions: Regulatory overhaul (leadership and enforcement of regulations, resolution of ambiguity in regulations, staffing, training, guidelines, and ethical principles [e.g., compensation]).Education and training of research professionals, clinicians, and regulators.Public awareness and empowerment. After a peak in 2009-2010, the clinical research sector in India appears to be experiencing a contraction. There are indications of challenges in regulatory enforcement of guidelines; training of clinical research professionals; and awareness, participation, partnership, and the general image amongst the non-professional media and public. Preventative and corrective principles and interventions are outlined with the goal of realizing the clinical research potential in India.
authors.affiliation: Duke Clinical Research Unit and Duke Clinical Research Institute, Durham, NC, USA.
authors.forename: Tal
authors.initials: T
authors.lastname: Burt
authors.affiliation: Novartis, Singapore.
authors.forename: Pooja
authors.initials: P
authors.lastname: Sharma
authors.affiliation: Medanta the Medicity, Gurgaon, Haryana, India.
authors.forename: Savita
authors.initials: S
authors.lastname: Dhillon
authors.affiliation: Novartis, Singapore.
authors.forename: Mukul
authors.initials: M
authors.lastname: Manchanda
authors.affiliation: Novartis, Singapore.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Mittal
authors.affiliation: Novartis, Singapore.
authors.forename: Naresh
authors.initials: N
authors.lastname: Trehan