Article type
Year
Abstract
Introduction:
Clinical trial registration enhances transparency, identifies reporting biases and increases public accessibility of trial results. Trial registration has been mandatory since 2009 for trials seeking licensing of drugs in India. Editors of 11 Indian medical journals jointly published a statement that prospective trial registration would be mandatory for all trials submitted from January 2010 (Satyanarayana et al. Indian J Med Res. 2008;127:104-5).
Objectives:
To evaluate the impact of the editorial policy on mandatory registration on trials published in journals that were, and were not, signatory to this policy.
Methods:
In August 2013, we assessed the instructions to authors of 63 Indian journals for their editorial policies regarding prospective trial registration. We identified controlled clinical trials published in these journals from January 2010 to August 2013. We extracted and analysed data on the type of trial, year of publication, country of origin, registration details and mention of trial registration number in the published article. We also searched the clinical trials registers (CTR) for registration details of the identified trials.
Results:
Only 21/63 (32%) of journal policies mandated clinical trial registration as a prerequisite for publication. During the period under survey, 686 controlled clinical trials were published in 58 of the 63 journals. Only 63 (9%) were registered in a CTR. Of the 560 trials (82%) conducted in India, only 48 (9%) were registered in a CTR. Only 15 (12%) of the 126 trials conducted outside India were registered in a CTR. Of the 63 trials which were registered, the trial registration number was not mentioned in 22 trials (35%). Only 14 of the 115 (12%) trials published in 10 of the 11 journals that were signatory to the mandatory trial registration statement were registered.
Conclusion:
Prospective registration of clinical trials in Indian medical journals continues to be substandard. This raises doubts about the validity of the results of the trials that were not properly registered.
Clinical trial registration enhances transparency, identifies reporting biases and increases public accessibility of trial results. Trial registration has been mandatory since 2009 for trials seeking licensing of drugs in India. Editors of 11 Indian medical journals jointly published a statement that prospective trial registration would be mandatory for all trials submitted from January 2010 (Satyanarayana et al. Indian J Med Res. 2008;127:104-5).
Objectives:
To evaluate the impact of the editorial policy on mandatory registration on trials published in journals that were, and were not, signatory to this policy.
Methods:
In August 2013, we assessed the instructions to authors of 63 Indian journals for their editorial policies regarding prospective trial registration. We identified controlled clinical trials published in these journals from January 2010 to August 2013. We extracted and analysed data on the type of trial, year of publication, country of origin, registration details and mention of trial registration number in the published article. We also searched the clinical trials registers (CTR) for registration details of the identified trials.
Results:
Only 21/63 (32%) of journal policies mandated clinical trial registration as a prerequisite for publication. During the period under survey, 686 controlled clinical trials were published in 58 of the 63 journals. Only 63 (9%) were registered in a CTR. Of the 560 trials (82%) conducted in India, only 48 (9%) were registered in a CTR. Only 15 (12%) of the 126 trials conducted outside India were registered in a CTR. Of the 63 trials which were registered, the trial registration number was not mentioned in 22 trials (35%). Only 14 of the 115 (12%) trials published in 10 of the 11 journals that were signatory to the mandatory trial registration statement were registered.
Conclusion:
Prospective registration of clinical trials in Indian medical journals continues to be substandard. This raises doubts about the validity of the results of the trials that were not properly registered.