India for the future of clinical trials

12-Jul-2005

India is rapidly developing into an important center for global clinical trials, but despite its growing popularity many companies remain unaware of how established the market now is. While they are positive concerning the possibilities of carrying out high quality research in India, they still have a list of concerns besides the distance and time difference.

"Many companies are only just realizing how exciting a destination India has become for clinical development," explained Dr Umakanta Sahoo, Head of Chiltern International's Indian office. "It has perhaps been slow, but there is now a perceptible change in the old mindset of people - from scepticism to acceptance - of the capability, skill-sets and quality of data in Indian trials".

There are numerous reasons as to why a company should choose India. It has a huge heterogeneous patient population, English-speaking western educated investigators (physicians) and a track record of sincerity in meeting regulatory and recruitment timelines, and most importantly well accepted good quality auditable data.

"Simply examining India from a recruitment perspective illustrates its potential," Dr Sahoo went on to comment. "Based on the feasibility and the past experience of many global multi-centric phase II & III studies, with the right approach most studies in India have the potential to recruit 4-5 times faster than corresponding centers in Europe and the USA".

Besides its considerable recruitment potential, India has 14,000 general hospitals, of which around 150 have served as sites for clinical trials in the recent years. Most studies have been carried out in medical colleges and hospitals, but they are also carried out in private hospitals and clinics. Most of these hospitals have state-of-theart infrastructures and instruments to perform the rigorous tests and procedures in a clinical trial.

"Cost-effectiveness, competition and the increased confidence on capabilities and skill sets have propelled many global pharmaceutical players to examine India", concluded Dr Sahoo. "The Indian market is evolving rapidly and increasing in sophistication. Thus it is essential that companies seek expert advice before entering the market in order to keep up with developments".

To contact Dr Umakanta Sahoo, General Manager, Chiltern International Private Limited, Mumbai India, please use the button 'Contact/Info'.

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