Study: Just half of postmarketing commitment trials are published
A new study published Monday in BMC Medicine finds that only about half of the clinical trials requested by the FDA as part of postmarketing commitments for newly approved drugs and biologics are published in peer-reviewed journals.
The study also found that information for nearly half of the postmarketing commitment studies subject to reporting requirements under section 506B of Federal Food, Drug, and Cosmetic Act (FDCA) was not up to date.
Conducted by researchers at Yale University, University of Connecticut and University of California, San Francisco, the study reviewed postmarketing commitments for the 110 new drugs and biologics approved from 2009-2012.
Unlike postmarketing requirements, which drugmakers must conduct as a condition of approval, postmarketing commitments are agreed to by drugmakers at the time of approval and are not required under statute or regulation.
More than half (55.5%) of the 110 approvals had one or more postmarketing commitment(s), with 33 requiring a new clinical trial. Of those, 27 were subject to Section 506B reporting requirements.
For the studies subject to reporting requirements, 12 (44.4%) were neither closed nor had an up-to-date status in publicly available databases on the FDA’s website.
The study did find, however, that nearly all the clinical trials requested as part of postmarketing commitments were registered on ClinicalTrials.gov (90.3%), most of which were marked as completed or terminated (82.1%). Of the completed or terminated studies all but one had reported results.
However, the authors found that most of the studies (81.8%) that had reported results on ClinicalTrials.gov reported their results after the scheduled submission deadline.
Only about half of the studies that were eligible for publication (i.e. completed or terminated in ClinicalTrials.gov or submitted, fulfilled or released according to the FDA) were published in peer-reviewed journals.
“Among the 29 registered or unregistered studies for which publication would be expected based on the most recent status provided by the FDA, pharmaceutical companies, or on ClinicalTrials.gov, just under half were published in a peer-reviewed journal (14 of 29 (48.3%)),” the authors write.
And while postmarketing commitments only make up 19% of the postapproval commitments and requirements imposed by the FDA, the authors say the data generated by postmarketing commitments “may be a potentially important source of information about drug and biologic safety and effectiveness after market approval.”
First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.
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