The US Institute of Medicine has published its report into transparency around clinical trial data. Somewhat behind policy developments in Europe on this topic, the US body first announced its intention to review the area in April 2014 and issued a discussion framework in January 2014.
In response to 23 public- and private-sector sponsors in the United States and abroad, the Institute of Medicine (IOM) assembled a committee to develop guiding principles and a practical framework for the responsible sharing of clinical trial data. In its report, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, the committee concludes that sharing data is in the public interest, but a multi-stakeholder effort is needed to develop a culture, infrastructure, and policies that will foster responsible sharing—now and in the future.
Specific recommendations in the report include that:
- Data sharing plans are registered with the trial registration before the trial begins
- Summary results are published within a year of a trial’s end
- Full data sets from a clinical trial should be shared within 18 months of the trial’s end
- Data sharing initiatives should be overseen by independent panels of experts and the public, and should be as transparent as possible.
The AllTrials campaign welcomed the report, but commented that its recommendations could have been stronger if they had included clear pathways to implementation and calls for audits of compliance.