Registering clinical trials in India: a scientific and ethical imperative.
The Clinical Trials Registery-India is an online, primary register of the WHO's International Clinical Trials Registry Platform. It was launched on 20 July 2007, and is now open to the prospective registration of clinical trials of any intervention conducted in India involving human participants. Registration is voluntary and free, and the register is searchable free of charge. Public disclosure of all 20 items in the WHO Trial Registration Data Set is mandatory for a valid registration number to be allocated. This number is required if the results are to be published in journals that endorse the International Committee of Medical Journal Editors' position on prospective trials registration. Trials in the Clinical Trials Registery-India will be included in the central repository of the WHO's International Clinical Trials Registry Platform search portal. In addition to the 20 items, the Clinical Trials Registery-India also requires mandatory disclosure of details of ethics committee and regulatory clearances. Further items pertaining to the methods that improve the internal validity of the trial are optional and serve as a template to improve trial design and the reliability of results. The success of this endeavour depends on the cooperation of the pharmaceutical industry, academic institutions, medical associations, ethics committees and medical journal editors in India. In the absence of legislation, ethics committees and medical journal editors have an important role in ensuring prospective registration of trials.
Tharyan
Prathap
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Professor B V Moses Centre for Research and Training in Evidence Based Health Care (ICMR Centre for Advanced Research), Christian Medical College, Vellore 632002, Tamil Nadu, India. prathap@cmcvellore.ac.in
Ghersi
Davina
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D028744:Ethics Committees, Research; D032984:Ethics, Research; D033161:Government Regulation; D006801:Humans; D007194:India; D012107:Research Design; D035842:Research Subjects; D014944:World Health Organization