Clinical research results absent in government database, risks patient safety

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Researchers failing to report the results of their clinical trials to the National Institutes of Health's ClinicalTrials.gov database could be putting future patients at risk and creating higher overall costs for health systems, a series of studies published in the British Medical Journal this week concluded, as reported by iHealthBeat.

One specific study, led by Dr. Andrew Prayle, a doctoral research fellow at the London-based National Institute for Health Research, found that of 738 trials examined that were subject to mandatory reporting, only 163 (22 percent) had results reported within one year of completion.

A second study, led by Dr. Joseph S. Ross, an assistant professor of medicine at Yale University School of Medicine, found that fewer than half of the clinical trials funded by the NIH were published in a peer-reviewed medical journal within 30 months of completion. Perhaps equally as alarming: one-third of such studies still weren't published after 51 months.

Ross and his colleagues wrote that although there may be reasons for lack of publication, there's still no excuse for such lengthy delays given that the results database that ClinicalTrials.gov offers is a complementary method of providing timely public access to study results. "Steps must be taken to ensure the timely dissemination of publicly funded research so that data from all those who volunteer are available to inform future research and practice," they said.

Richard Lehman, a senior research fellow with the department of primary care at the University of Oxford, and Elizabeth Loder, a clinical epidemiology BMJ editor, insisted researchers should be accountable to reporting deadlines. "When the word 'mandatory' turns out to mandate so little, the need for stronger mechanisms of enforcement becomes very clear," they wrote in a BMJ editorial. They go on to write that patients will "have to live with the consequences of these failures for many years to come," unless more is done.

To learn more:
- here's the iHealthBeat article
- check out Prayle's study
- read Ross' study
- here's the editorial

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