Volume No : (2015) Volume: 03 Issue : 16 Year : 2015 Page No: 645
Authors : Arvind Pandey, Abha Aggarwal and Jyotsna Gupta
Abstract :
The Clinical Trials Registry- India (CTRI), hosted at the ICMR’s National Institute of Medical Statistics (NIMS), is an online public record system for registration of clinical trials being conducted in India. The CTRI (www.ctri.nic.in) was launched on 20th July 2007. The launch of the CTRI on 20th July 2007 was a landmark event in the medical history of India, as it was first of its kind in Asia, before China, Sri Lanka and it establishes, for the first time in India, an unbiased, scientific public record of clinical trials being conducted in the country. The registry is a web based repository of all registered clinical trials conducted in the country including ongoing, completed and future clinical trials. Registration of trials in the CTRI is free. All registered trials are publicly available and searchable by anyone free of charge. The mission of the CTRI is to encourage all clinical trials conducted in India to be prospectively registered before the enrollment of the first participant and to disclose details of the 20 mandatory items of the WHO International Clinical Trials Registry Platform (ICTRP) dataset. The CTRI is linked to ICTRP and the registered trials could be viewed from ICTRP globally. Setting up of the CTRI would ensure that all clinical trials conducted in India are publicly declared and identifiable and a minimum set of information of all clinical trials is freely available to physicians, health researchers, academicians, pharmaceutical industries as well as the common man. Registration of trials will ensure transparency, accountability and accessibility of clinical trials. Further, it would help to overcome publication bias that exists because of the tendency of researchers to publish only “positive” results. Moreover, standard of research in the country could be improved while avoiding unnecessary duplication of trials. Initially trial registration in the CTRI was voluntary now it has been made mandatory w.e.f 15th June 2009 by Drugs Controller General of India. To increase the awareness about this system various dissemination workshops were conducted in the past across the country. Currently as on 1st July 2015 about 6000 trials have been registered since inception of which about 48% trials were registered before the recruitment of first patient. Once awareness regarding the setting up of the CTRI spreads, it is likely that the current trickle of prospectively registered trials will soon become a flood. Any researcher who plans to conduct a trial involving human participants, of any intervention (drug, surgical procedure, preventive measures, lifestyle modifications, devices, educational or behavioral treatment, rehabilitation strategies and complementary therapies) is expected to register their trial in the CTRI before enrollment of the first participant. Therefore by publishing this in various medical journals would lead to increase awareness about the system and expected to bring more accountability and transparency in conduct of clinical trials in the country.
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