Two thirds of Indian medical and dental journals publish unregistered studiesBMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f1564 (Published 08 March 2013) Cite this as: BMJ 2013;346:f1564
An analysis of Indian medical and dental journals has found that less than a third require authors to have a clinical trial registration number for studies submitted for publication despite this having been a national requirement for nearly four years.
For the survey, published in Indian Pediatrics (the publication of the Indian Academy of Pediatrics), researchers examined the “instructions for authors” of 30 journals that they identified from the National Library of Medicine Catalog as having editorial offices in India and publishing clinical trials.1
They found that a trial registration number was required in only nine (30%) of the journals despite the fact that in June 2009 the drug controller general of India made it mandatory for researchers to register their trials.
In 2008 nine of the 30 journals investigated signed the “Statement on publishing clinical trials in Indian biomedical journals,” which meant that from January 2010 they would consider a trial for publication only if it had been registered, but only four of these required authors to submit a clinical trials registration number.
The analysis also found that 16 journals (53%) encouraged authors to adhere to the Consolidated Standards of Reporting Trials (CONSORT) statement in the reporting of trials, but only two required them to submit a CONSORT checklist.
Soumyadeep Bhaumik, a doctor in Kolkata and an author of the study, told India’s Statesman newspaper: “Clinical trial registration helps reduce selective reporting and publication bias and enhance transparency, validity, availability, and public accessibility of trial results.”
Registration of trials also allows researchers and funding agencies to check they are not duplicating work elsewhere, and help recruitment, said Bhaumik, who is also a contributor to the news pages of the BMJ. Having this information in the public domain “also helps improve the quality of clinical trials by making it possible to identify potential problems, ethical issues, and details about conflict of interests,” he said.
If Indian journals do not adhere to international standards and require trials to be registered they could be seen as “a backroom of unregulated clinical trials,” said Bhaumik. In the worst cases, publishing unregistered trials could lead to the approval of medical interventions that should not be available, he said.
Cite this as: BMJ 2013;346:f1564