CTRI makes registration of clinical trials only prospectively from April 1, 2018

PSM News /

Mumbai, November, 2017:

 

The Clinical Trials Registry of India (CTRI), set up by the Indian Council of Medical Research (ICMR) will register clinical trials/studies only prospectively from April 1, 2018, which practically means before the enrollment of the first patient. Currently CTRI accepts and registers trials which are ongoing and completed.

 

Senior officials in the ICMR said that this system will be discontinued from April 1, 2018 as at the time of publication, many journals insist upon prospective registration of clinical trials.  For prospective registration, it has to be ensured that at the time of clinical trial submission, patient enrollment in the study has not begun and in the CTRI form it should be mentioned 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 registration trial will be flagged as Trial Registered Retrospectively. Once registered, trial flagging cannot be changed, officials said.

 

CTRI is a free and online public record system for registration of clinical trials being conducted in India that was launched on July 20, 2007.  Initiated as a voluntary measure, trial registration in the CTRI was made mandatory by the Drugs Controller General of India (DCGI) since June 15, 2009.  Moreover, Editors of Biomedical Journals of 11 major journals of India declared that only registered trials would be considered for publication.

 

The main objective of the CTRI is to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the 20-item WHO ICTRP dataset, as well all items of the CTRI dataset, in order to improve transparency and accountability; 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; conform to accepted ethical standards; and lead to reporting of all relevant results of all clinical trials in India and the region.

 

It is also aimed at giving all required information about a trial at a single point to the public and researchers and make trials more transparent. It also would help stop the practice of suppressing negative results of trials by companies.

 

While this register is meant primarily for trials conducted in India, the CTRI will also accept registration of trials conducted in other countries in the region, which do not have a Primary Registry of its own.

 

Clinical trials hold enormous potential for benefiting patients, improving therapeutic regimens and ensuring advancement in medical practice that is evidence based. Unfortunately, the data and reports of various trials are often difficult to find and in some cases do not even exist as many trials abandoned or are not published due to "negative" or equivocal results. However, this tendency for availability of only selective information from the myriad clinical trials conducted is not commensurate with the practice of "evidence-based medicine". Today, world over, a need has been felt on the imperative for transparency, accountability and accessibility in order to re-establish public trust in clinical trial data. And this would be feasible only if all clinical trials conducted are registered in a centralized clinical trials registry. Registration of trials will ensure transparency, accountability and accessibility of clinical trials.