FROM PLOS MEDICINE

The World Health Organization is calling for more timely reporting of clinical trial results.

Building on a 2005 statement asserting the ethical imperative of registering clinical trials and reporting data, the WHO now urges investigators to post primary clinical trial results within 12 months of study completion, and to publish their results in a peer-reviewed journal within 24 months of the study’s completion.

In an essay published online in PLOS Medicine (PLoS Med 12(4): e1001819. doi:10.1371/journal.pmed.1001819), Dr. Vasee Moorthy, WHO technical officer, wrote that researchers should report any as-yet unpublished trial results, and improve links between their clinical trial registries and their published results.

In an interview, Dr. Moorthy said the WHO was bringing underreporting of clinical trial data to the public’s attention because of the potential risk posed by “the circulation of ineffective or harmful medical products” that can occur when not enough data are available to evaluate those products.

Underreporting is encouraged in the current research climate, which focuses on positive results that “are likely to lead to higher profile publications and more funding. But many trials are negative, and without incentives and requirements these can often go unreported,” Dr. Moorthy said.

Since the WHO’s 2005 call for better data tracking, there has been an increase in clinical trial registration, according to Dr. Moorthy and his coauthors. Despite this uptick in trial registration, results reporting has lagged across all intervention classes, regardless of whether a trial was sponsored by a pharmaceutical company or an individual investigator.

Citing a study published in the BMJ , Dr. Moorthy and his coauthors noted that nearly a quarter of all clinical trials with 500 or more participants, registered at clinicaltrials.gov and completed by 2009, had no reported results. In all, this equals unreported data on nearly 300,000 participants, up to as many as 60 median months after the trials were completed.

These failures constitute a waste of “precious health resources on suboptimal medicines, and slows down the research process for life-saving medicines,” Dr. Moorthy said.

The problem is an international one. “The information we have indicates underreporting is a general issue without national borders,” said Dr. Moorthy.

The Helsinki Declarations have called for researchers to make all findings public in a timely manner.

In the United States, the Department of Health & Human Services has proposed an expanded scope for clinical trials to be reported by law and clarified requirements for posting results on clinicaltrials.gov, and the National Institutes of Health is working to mandate clinical trials registration and results reporting for all NIH-funded clinical trials.

Still, a recent article published online in the New England Journal of Medicinestated that despite the Food and Drug Administration’s power through the Amendments Act of 2007 to issue fines of $10,000 a day against investigators who do not report their findings to clinicaltrials.gov, the agency has yet to levy a single fine. Particularly troubling, the report said, was that the majority of NIH-funded trials were not even registered with clinicaltrials.gov, and that industry-sponsored trials, as well as government-sponsored ones, were equally poor in their efforts to maintain transparency.

In an editorial accompanying Dr. Moorthy’s essay in PLOS Medicine, Dr. Ben Goldacre, a senior researcher at the Centre for Evidence-Based Medicine, Oxford (England) University, wrote that declarations of the necessity of data reporting were not enough and called for the addition of audits to clinical trial protocols.

Taking a punitive approach, Dr. Goldacre wrote that an audit of who has completed trials and posted their data would be easy to do and that “the very act of creating such data would allow us to name and shame poor performers, and also to reward best practice.”

Neither Dr. Moorthy nor Dr. Goldacre had any relevant disclosures.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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