From April, companies and organisations that have registered for clinical trials in India will have to disclose the outcomes of their tests within a year of completing them.
“We never get to know about negative trial results … globally less than 60% of clinical trial outcomes are disclosed,” said Soumya Swaminathan, Head, Indian Council of Medical Research.
Currently, all trials in India are registered on the Clinical Trials Registry — India (CTRI).
Of the trials registered with the CTRI (as on June 30, 2017), 3,318 are prospective and 5,604 are retrospective registrations — which means details of these trials were uploaded after the companies conducting them had begun recruiting patients.
India has had a mixed record with clinical trials, with reports, earlier in the decade, of prospective drugs being tested on people who were not aware of what they had signed up for. In 2013, the Supreme Court of India forbade fresh applications for clinical trials following a public interest litigation petition due to reports that there had been a high number of deaths among those registered for trials.
Proper mechanism
The court asked the government to set in place a proper mechanism to regulate trials. This led to measures which required that compensation be paid to patients affected by trials and that there was audio-visual proof that participants had indeed consented to take part in a trial. However, these requirements were later eased and a streamlined system is in place which, according to clinical-trial companies, is much more conducive to organising trials.
“There have been instances in the past that threw up problems with trials but we can’t vilify the process itself,” Dr. Swaminathan added. Among the major trials expected is that of several prospective tuberculosis vaccines that will begin to be tested in 20,000 patients and involve a recombinant vaccine as well as a killed mycobacterium.
Dr. Swaminathan, who is set to take over as deputy director-general at the World Health Organisation later this year, said the ICMR would also commission a study to look at the root cause of deaths in children in Gorakhpur and surrounding regions.
