Friday, May 1, 2009

Outsourcing Clinical Trials in Emerging Regions: INDIA and CHINA

Priya Pawar, Vice-President, Business Development, SIRO CLINPHARM, USA
Dr Ross Horsburgh, VP Asia Pacific, KENDLE INTERNATIONAL

Why is India so attractive for clinical trials? There is a very large population. In addition, you can see diseases that affect both the developing world and the developed world. India has a robust infrastructure in respect to facilities and professionals. The number of physicians that have been educated in the western world then returned to India has translated into more trails being conducted in India.

In order to begin a clinical trial in India, you need to submit a dossier to the Indian government. It would take about 6-12 weeks. A faster review would happen if you’ve been approved in other countries such as the US.

Looking towards the future in clinical trials, India has to build upon traditional strengths which are infrastructure, tools, and quality. Other initiators to ensure suitable partnerships are awareness, collaboration and regulatory areas. A company should obtain an experienced partner who has already been there.

Ross J. Horsburgh talked about the opportunities in Asian countries other than India. Taiwan has the highest number of clinical trials in Asia, followed by Japan, South Korea, China and India. Vietnam is becoming an interesting place to do studies. Why Asia? If the company performing the trial doesn’t have a vested interest in the clinical trial, the quality and results will reflect that. Areas need to care about the clinical trials they are performing. Drivers for going to Asia are the science and markets involved. They have different relative markets. Phase I trials are typically conducted close to the area of the sponsor. In Phase III, the big expensive studies need access to the number of patients. We’re now seeing an increase in the science drivers. There is growth for Pharma is in Asia.

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