Register trials, insist Indian editors
Published in The Hindu on April 24, 2008
Publishing clinical trial results in Indian biomedical journals after January 2010 will become difficult unless the trials have already been registered.
The editors of 11 Indian biomedical journals have stated that only clinical trials which have been prospectively registered will be considered for publication.
The requirement
It requires that all trials started after June 2008 should be registered prospectively and those undertaken before June 2008 need to be registered retrospectively.
The statement says that “… unanimously decided that the editors have the responsibility to promote the registration of all clinical trials being conducted in India.”
The initiative by the Indian editors is very much in line with the decision take by more than a dozen international medical journal editors three years ago. The International Committee of Medical Journal Editors (ICMJE) has stated that they would publish any papers connected with clinical trials only if the trials have been registered.
The ICMJE policy is based on the assumption that “missing out on the chance of publishing favourable findings in prestigious journals by not complying with this policy is undesirable for the industry.” And it has turned out to be true. The number of trials registered in public registries has shot up ever since.
The publication of clinical trial results is fraught with problems. Drug companies very often suppress negative results while exaggerating the positive ones and “downplaying harms and talking up benefits.”
One of the ways to ensure that pharmaceutical companies that carry out multicentric trials do not cherry pick favourable results from only a few trial centres to make the drug appear safe and efficacious is to ensure that the companies register the trials at the very start.
But with registration being voluntary, one of the ways to make them comply rests with editors. And that is precisely what the 11 Indian biomedical editors have decided to do.
The Indian clinical trial registry launched in July last year does not require result submission.
“The registry has not reached the stage to make it [results] mandatory,” said Dr. Vasantha Muthuswamy, Senior Deputy Director General, ICMR, New Delhi. “It may take some more time. Even the FDA has done it only now.”
The statistics
According to Dr. Abha Aggarwal, Deputy Director of the National Institute of Medical Statistics and the Co-ordinator of the Clinical Trial Registry India, 34 trials have been registered as on April 15, 2008. 15 more are pending and 15 have been sent back for want of complete details.
The good news is that 15 pharmaceutical companies, 3 contract research organisations (CRO) and 16 academic/hospitals have registered their trials.
“There are totally 184 registered users,” Dr. Aggarwal said. “They have expressed their intent to register trials in future.” There are 47 drug companies and 34 CROs among these registered users.
