Clinical trial registration made compulsory in India from 15th June

Trial registration is now mandatory before the enrollment of the first patient

Indian government has made registration of all clinical trials conducted in the country mandatory from 15th June 2009.

The Drug Controller General of India (DCGI) has brought out a notification to this effect informing the applicants to register the clinical trial in ICMR Clinical Trial Registry  before initiating the trial process.

The new registration norm will be applicable to the clinical trials started after 15th June 2009, stated the notification from the Central Drugs Standard Control Organisation (CDSCO) –the DCGI’s office.

Registration of clinical trials in the registry has not been held compulsory in India so far, even though India has become a sought-after destination for outsourcing clinical studies for drug makers across the world.

Currently, a total 987 clinical studies are being run at various centers in India, according to ClinicalTrials.gov, a service by US National Institutes of Health.

As of now, only less than 25 of the nearly thousand ongoing clinical studies are registered in India with the Clinical Trials Registry because such registration formalities were voluntary for the companies.

Dr Surinder Singh, DCGI, has been reiterating the need for making the registration of clinical studies mandatory for sometime now.  Recently, Dr Singh announced in press gathering that clinical trials registration, along with their auditing, would be made compulsory in India, as part of his efforts to bring in more accountability and transparency into the controversial clinical trail industry.

“Registration of clinical trials in a publicly accessible registry is very important as it improves the accountability of the stake-holders and also ensures that key information is made available to the public,’’ stated the notification dated 1st of June, 2009.

The Clinical Trials Registry- India (CTRI) has been set up by the ICMR’s National Institute of Medical Statistics (NIMS) and is funded by the Department of Science and Technology (DST) through the Indian Council of Medical Research (ICMR).

The idea behind setting up of the Clinical Trials Registry-India (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 dataset is meant to: 1) improve transparency and accountability, 2) improve the internal validity (details of the methods of the trial that produce reliable results, primarily the method of random sequence generation, concealment of allocation, blinding of participants and investigators, and inclusion of all participants results) of trials right from the design,through conduct and reporting, 3) conform to accepted ethical standards and 4) lead to reporting of all relevant results of all clinical trials in India and the region.

The CTRI is an online register of clinical trials being conducted in India.

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) are expected to register the trial in CTRI before enrollment of the first participant.

Registration of trials in the CTRI is free. All registered trials will be made publicly available. The CTRI will be searchable by anyone free of charge.

The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

The Declaration of Helsinki, revised by the World Medical Association in October 2008, now calls for mandatory prospective clincial trial registration in a publicly accessible database.