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IOM seeks comment on clinical trial data-sharing guidelines


By Sabriya Rice
Posted: January 22, 2014 - 2:45 pm ET
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The Institute of Medicine is asking experts for input on how to responsibly navigate the complex challenges of sharing data from clinical trials across disciplines.

In a new discussion framework, the IOM solicits feedback on key concerns for academic researchers and manufacturers, such as increasing transparency, maintaining patient privacy, protecting intellectual property and building public trust in research results.

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“Many stakeholders have valid interests that sometimes are not aligned,” wrote Bernard Lo, chair of the Committee on Strategies for Responsible Sharing of Clinical Trial Data. “Proposing an approach that works for the wide range of clinical trials may be daunting.”

Access to data traditionally has been considered proprietary. Scientists attempting to review small, often unpublished studies, especially those from the pharmaceutical industry, have not been able to gain access to results. This culture is steadily changing, though, and the data-sharing movement has gained substantial momentum during the last decade, the IOM notes in the document.

The National Institutes of Health and some pharmaceutical and device companies have already implemented data sharing policies. The European Medicines Agency established an “access-to-documents policy” in 2010, which was met with resistance from the industry. However, the details of these policies vary.

“I think the IOM committee did a good job of laying out the questions and principles that can lead to successful sharing of clinical data,” said Dr. Michael Carome, director of the Health Research Group for Public Citizen. “This is clearly a preliminary report, and the thought process could evolve with the additional input. What ultimately will matter is the formal recommendation.”

Public comments may be submitted online to the IOM committee through March 24, 2014. The committee's final recommendations are expected at the end of the year.

Follow Sabriya Rice on Twitter: @MHSRice


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