CLINICAL TRIALS IN INDIA 2010: AN ANALYSIS & CURRENT STATUS

B. Ramya Sree
Department of Biotechnology, Sree Vidyanikethan Engineering College, Tirupati
Jyothi M. Joy
Department of Pharmacognosy, Sree Vidyanikethan College of Pharmacy, Tirupati

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A clinical trials registry, sometimes abbreviated as a CTR, is an official platform and catalog for registering a clinical trial. CTRI (Clinical Trials Registry, India) is an organization set up by National Institute of Medical Statistics (NIMS), awards territorial rights for conduction of clinical trials in the country, in accordance with the governing principles of WHO’s ICTRP (International Clinical Trials Registry Platform) and other ethics committees. Clinical trials registry provides increased transparency and access to clinical trials, made available to the public. The present study is based on a database of the clinical trials registered in India in the year 2010. The study clarifies the major therapeutic areas on which maximum trials were done, who were major sponsors- pharmaceutical companies or academics or government or biotech industry or CRO’s or any other, which phase of clinical trials were done in India. The data extraction was done by internet. It was found that in the year 2010 the sponsorship of clinical trials in India were done mainly by Industries (57%) & Academics domain (19%) then Other type of sponsors with (14%), then Biotech companies with (6%), Government funding (3%) and least trials were sponsored by CRO’s, (1%). The major therapeutic areas of concern in which maximum trials were conducted on cardio-vascular diseases, diabetes, neurodisorders, cancer, respiratory diseases, ophthalmic diseases, arthritis etc. The trial designs were mostly randomized (70%) followed by single arm trial (15%), then other type (10%) and least were non-randomized (5%). Phase 3 trials were mostly conducted (46%), and phase 1 was least (8%), because as per the rule phase 1 & 2 can be conducted anywhere but phase 3 must be conducted in the country where the drug has to be marketed. Phase 1 trials were 8%, phase 2 trials were 14%, phase 4 trials were 14% and in 18% of trials the status was not mentioned. As per the status mentioned of the trials in the CTRI website most of the trials were complete (69%).

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