To ensure transparency, safety and quality standards across human trials, India’s apex research body has made it mandatory for all researchers to register trials before they begin.
Beginning April 1, the Clinical Trials Registry India (CTRI) will register clinical trials/studies prospectively— before the first participant is enrolled.
“A trial must be registered with a central agency before it begins and the information should be in public domain, and updated regularly for anyone to have access,” said Professor Arvind Pandey, former director, CTRI, who established the registry in 2007. “Trials were being registered, but often retrospectively. Now everyone will have to follow a standard protocol ,” he said.
Under the new rule, any researcher conducting a trial for drugs, surgical procedures, preventive measures, lifestyle modifications, devices, educational or behavioural treatment, rehabilitation strategies, including in the AYUSH system, must register before enrolling the first participant.
The trials that have already begun will not be registered after April 1, 2018.
The current trend is to take clearances from respective ethics committee and start trials without registering with CTRI.
The registry was launched in 2007, and trial registration was made mandatory by the Drugs Controller General of India (DCGI) in 2009.
{{/usCountry}}The registry was launched in 2007, and trial registration was made mandatory by the Drugs Controller General of India (DCGI) in 2009.
{{/usCountry}}“Several medical journals of repute do not publish the research if it is not registered with the respective central agency,” said Prof. Pandey.
Trial registration involves public declaration and identification of investigators, sponsors, interventions, patient population etc. before recruitment.
The data and reports of various trials are often difficult to find and in some cases do not even exist as many trials are abandoned or not published due to negative or equivocal results.
“Even if the trial fails, it would help in learning the results of the trial. The directive will be strictly followed from next year,” said Pandey.