Fewer than half of NIH funded clinical trials are published within 30 months of trial completion, a recent study published in BMJ reports. A companion paper reveals that nearly four out of five studies fail to adhere to mandatory public data reporting. Together, they shed light on the degree to which publicly funded research fails to reach scientists, clinicians, and the general public.
The first study, “Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis,” by Joseph Ross and others, tracks the publication fate of 635 clinical trials reported as having been completed by the end of 2008. The U.S. Food and Drug Administration Amendments Act (FDAAA) of 2007 requires that clinical trials subject to FDA regulation be registered and reported in ClinicalTrials.gov. The International Committee of Medical Journal Editors (ICMJE) also requires trial registration as a requisite for publication in one of its member journals.
Ross reports that less than half (46%) of the completed trials were published in a peer-reviewed journal indexed by Medline within 30 months trial completion. The median time to publication was 51 months (4 and a quarter years) after trial completion. Overall, 68% of the trials were published in a journal indexed by Medline although 32% remained unpublished. For those trials that were published, the median time to publication was nearly two years (23 months) after trial completion.
In addition, trials completed in 2007 or 2008 were more likely to be published within 30 months than those completed before 2007 (54% vs. 36%, respectively) suggesting that timely reporting of results in a peer-reviewed journal appears to be getting better, not worse. The authors, however, are not completely sanguine about their results:
[S]ubstantial amounts of publicly funded research data are not published and available to inform future research and practice.
While the 2008 NIH Public Access policy requires that final, peer reviewed manuscripts be submitted to PubMed Central no more than one year after publication, this study illustrates that many publicly funded trials simply go unpublished.
The FDAAA requires that most non-Phase I trials of FDA regulated drugs and other medical devices report summary results on ClinicalTrials.gov within 12 months of trial completion, regardless of publication status. Ross argues that ClinicalTrials.gov could provide that public platform for providing timely public access to study results.
Only it doesn’t.
Reporting in a companion article, “Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study,” Andrew Prayle and others report that of the 738 clinical trials classified in ClinicalTrials.gov as requiring mandatory reporting within 12 months of trial completion, just 22% had done so. In comparison, trials not covered by the FDAAA had a 10% compliance rate. Industry-funded trials subject to mandatory reporting were more likely to report results over government-funded trials.
Prayle argues that unless the reporting rate increases, federal legislation will not achieve its goal of improving the accessibility of clinical trial results. The real problem that prevents clinical trial data from reaching fellow researcher scientists, clinicians, and the general public, Prayle writes, is the unwillingness of authors and sponsors of these studies to report their results, as required by law:
ClinicalTrials.gov allows dissemination of summary results independent of a publisher. Our study supports the suggestion that study investigators and sponsors act as the principal sources of reporting bias; reporting of results to ClinicalTrials.gov is independent of peer review, manuscript preparation, and editorial priorities.
While scientific journals, and those run them, have become the focus of everything that is wrong with scientific communication today, the reluctance of authors and their sponsors to follow established guidelines — and the government’s inability to enforce its own laws — should be brought into the discussion on how to improve the system.