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Times of India
14 November 2011
Pune India

Of the total 1,905 published clinical trials or studies in the country till date, Delhi tops with 308 publications, Bangalore with 137, Mumbai with 125 and Pune with just 35. Globally, publication on clinical trials or studies is 23.27% in the US, 6.291% in China, whereas it is only 1.904% in India. Here, comes the need for many more investigator–driven clinical trials in the country, said Dr Nilima A Kshirsagar, national chair (clinical pharmacology), Indian Council for Medical Research (ICMR) .

Speaking at the seminar on the occasion of Chest Research Foundation’s 10th foundation day here on Sunday, Kshirsagar said, “though we may say we look forward to see India as the major clinical hub, we are still far behind in clinical trials when compared to other countries. We have a long way to go.’’

The Dean ESI–PGIMSR, government of India, MGM hospital, Mumbai, Dr Kshirsagar said, at present, there are a total of 2,102 registered clinical trials in the country. The advantages include well–trained English speaking doctor healthcare workers, large patient pool and low cost. But there are disadvantages too, like slow regulatory process, documentation and ethics.

Kshirsagar pointed out that India has to focus on clinical research and take up studies on prevention of diseases. There is also a requirement of establishment of more institutes that can take up research on clinical trials.

According to Kshirsagar, there is a need for substantial funding for the establishment of these institutes. These institutes should have adequate diagnostic tools to take up studies related to genetics and biochemical tests. This funding can be from industries or medical sector. At present, pharmaceutical industries are looking at Pune for future prospect in clinical trials, she said.

So what are the challenges in clinical trials? Mrudula A Phadke former vice––chancellor of Maharashtra University of Health Sciences said there definitely a need for more research on clinical trails.

Dr Kshirsagar stressed there was a need to educate patients and doctors in understanding research. “We always cannot follow the research that are done abroad. It should be done in the best intent of the patients,’’ she said.

On managing educational and research institutes in the current context, Dr Sharad Joshi, head and dean for corporate relation Vishwakarma Institute of Management, Pune, pointed out there is a need for collaborative effort between education and research, which is missing at present. Neitherr learning nor skills are being delivered in the classroom.

Dr Sundeep Salvi, director, CRF, highlighted that of the top 10 causes of deaths in Maharashtra, chronic obstructive pulmonary disease (COPD) is the highest. Thirty three per cent of deaths are attributed to COPD. And there will be an increase in COPD deaths in the coming years, he said.

“Unfortunately, India’s overall contribution to world’s medical literature is just 0.5% and to respiratory research is 2% in the country. There is a lack of public health research output from India. We use imported knowledge and that may not necessarily be relevant to India. So we need to generate our own knowledge and improve on it,’’ he said.

At present, several investigator–initiated clinical trials and support capacity building of clinical trial sites, pharmaceutical companies and clinical research organisations are being carried out at CRF, he added.

Clinical trials in India

Cancer 21% Infectious disease 16 % Cardiovascular disease 14% Respiratory 13% Central nervous system 7% Other diseases 14%

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