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Regulatory Focus™ > News Articles > BMJ: Lack of Research Transparency Breaks Regulations, Hurts Patients

BMJ: Lack of Research Transparency Breaks Regulations, Hurts Patients

Posted 04 January 2012 | By Alexander Gaffney, RAC

A series of studies published this week in the British Medical Journal by groups of researchers from various universities have found serious lapses in clinical trial reporting and transparency.

Among the findings:

A study led by Andrew Prayle of Nottingham University found that only 22% of trials registered at ClinicalTrials.gov had reported their results in the mandatory one-year post-trial time frame;
A study conducted by researchers at the Yale School of Medicine found that fewer than half of National Institute of Health (NIH)-funded studies were published within 30 months of the clinical trial's completion.  The study also found that, "after a median of 51 months after trial completion, [a] third of trials remained unpublished.";
A study conducted by researchers at the University of California San Francisco found that when the results of unpublished studies were taken in to account, 46% of meta-analyses show lesser efficacy, and another 46% show greater efficacy; and
The majority of meta-analyses do not discuss the potential publication, availability, or selection biases present in their analyses.

"The influence of funding body and sponsor seems to be considerable. Industry funded trials subject to mandatory reporting were more likely to report results compared with other funders," wrote the Nottingham researchers. "Phase III and IV studies seem more likely to be reported than phase II studies."

"[The] current culture of research needs to prioritize the timely public dissemination of research findings, ideally via peer-reviewed journals, for research funded by both public and private sources," said the first author of the Yale study, Dr. Joseph Ross.

Milwaukee Journal-Sentinel journalist John Fauber noted that the difficulties of finding and accessing unpublished data had been a major component Vytorin, Avandia, and Multaq scandals.

Richard Lehman, MD, concluded that a solution might include subjecting researchers who fail to submit data to "disciplinary action by professional organizations."