The Drug Controller General of India (DCGI) has decided to make registration of clinical trials mandatory starting June 15, 2009. Therefore, any clinical trials initiated after this date will require registration through the Clinical Trials Registry – India (CTRI). CTRI was set up by the Indian Council of Medical Research’s National Institute of Medical Statistics (NIMS).
All interventional clinical trials conducted in India and involving Indian patients need to be registered. An interventional clinical trial is any research study that prospectively assigns people to one or more health-related interventions (e.g., preventative care, drugs, surgical procedures, behavioral treatments, etc.) to evaluate their effects on health-related outcomes. Early and late trials, trials of marketed or non-marketed products, and randomized or non-randomized trials should all be registered.
CTRI is an online register of clinical trials being conducted in India. Applicants would declare not only the twenty items of the Trial Registration Data Set as required by the World Health Organization’s (WHO) International Clinical Trials Registry Platform (ICTRP) but also a few additional items. These include ethics committee approval status, regulatory clearance by the DCGI, etc. before the enrollment of the first patient. Then, the Registry will collect information on all prospective clinical trials to be undertaken in India and make this information available to the public.
To register a study, applicants will submit information including the basic data required by the ICTRP and will receive a WHO assigned unique identification number. In addition, CTRI will encourage the investigators to include subsequent protocol amendments and give regular updates on the status of the trial. The person responsible for registering the trial is either the principal investigator or the primary sponsor, to be decided by an agreement between the parties.
Information needed for the registration include sponsor and PI information, target sample size, outcomes, phase of trial, method of allocation concealment, blinding and masking, etc. The application is all online at ctri.in