The Clinical Trials Registry of India (CTRI’s) new administer of registration of clinical trials only prospectively has become effective from April 1, 2018. The new rule for all intents and purposes implies that registration of clinical trials/studies will be done before the enlistment of the first patient.
Till now, CTRI accepts and registers trials which are ongoing and finished. CTRI, set up by the Indian Council of Medical Research (ICMR), is a free and online public record system for registration of clinical trials being led in India that was propelled on July 20, 2007.
Started as a voluntary measure, trial registration in the CTRI was made mandatory by the Drugs Controller General of India (DCGI) since June 15, 2009.
As per senior ICMR authorities, the system of accepting and enrolling trials which are progressing and completed will be discontinued from April 1, 2018, as at the time of publication, many journals demand prospective registration of clinical trials.
For prospective registration, it must be ensured that at the time of clinical trial submission, patient enrollment in the study has not started and in the CTRI form it should be specified that the date of first enrollment (India) is an anticipated future date and recruitment status of trial (India) should be Not Yet Recruiting.
If the above conditions are not met, upon enlistment trial will be flagged as Trial Registered Retrospectively. Once registered, trial flagging can’t be changed, authorities said.
The main objective of the CTRI with full disclosure of the 20-item WHO ICTRP dataset is to ensure that each clinical trial directed in the region is prospectively registered, to all items of the CTRI dataset, to enhance transparency and accountability; enhance the internal validity (details of the methods for the trial that produce reliable outcomes, primarily the method of random sequence generation, concealment of assignment, blinding of participants and investigators, and consideration of all members results) of trials right from the outline, through direct and reporting; conform with acknowledged ethical standards; and prompt announcing of every relevant results of all clinical trial in India and the region.
It is also aimed at giving all required data about a trial at a single point to public and specialists and make trials more transparent. It also would help stop the practice of suppressing negative results of trials by organizations.
While this register is implied primarily for trials led in India, the CTRI will also acknowledge enlistment of trials led in different countries in the region, which don’t have its very own Primary Registry.