The Indian Council of Medical Research (ICMR) has decided to make it mandatory for all clinical trials to report results back to them, regardless of whether they are published in peer-reviewed journals or not. The ICMR runs the Clinical Trials Registry of India (CTRI) where investigators have to mandatorily register trials but it is only recently that the council realized that it has no information on trial outcomes.
“A lot of times when the results are negative, especially for trials that are funded by pharmaceutical companies, the data is never made public. It is only the positive results that are made public or published in peer-reviewed journals. It is obviously easier to get the latter published but we think it is important for ICMR to be informed about the outcome of trials. So investigators will have to within a year of completion of a trial come back and inform the registry about the outcome. We will implement it from April 2018,” said outgoing ICMR DG Dr. Soumya Swaminathan. Dr. Swaminathan will soon take charge as the deputy director-general of WHO.
There is no data on what percentage of Indian trials get published but internationally only 50-60% trials make it to the pages of peer-reviewed journals. Even if one takes that as a standard, that would mean a large number of Indian trials happen without disseminating any information about their outcomes which means not just that negative results are never known but is also detrimental for science per se as the same trial may be done by other investigators without knowing that a previous attempt has already yielded negative results.
The CTRI, which does not have the mandate to take action against errant investigators, will instead blacklist those that do not comply, Dr. Swaminathan said. “That would mean the next time they come for a grant or for a registration they would not get it because they are already on the blacklist,” she said.
The number of trials registered with CTRI has risen steadily from 545 in 2009 to 1,327 in 2017. The CTRI has 8,950 trials registered as on June 30, 2017, of which 2,036 have been completed and 28 terminated.
Dr. Ashok Vaid, chairman medical and haemato oncology at Medanta Medicity said the decision to make outcome reporting mandatory for clinical trials was a “rational” one. “This debate has been on in the medical world for a very long time that even negative trials should see the light of day. It is the only logical thing to do. No medical professional would ever want trial results to be suppressed. It may sometimes be in the interest of pharmaceutical companies but never a scientist or a medical professional,” he said.
Source & Credits: Indian Express