The Institute of Medicine, part of the National Academies, has been working on a report outlining recommendations on clinical trial data sharing (H/T The Scientist). The report comes from the perspective (which I share) that there are benefits to making more clinical trial data publicly available. Released on Wednesday, the report recommends a multi-stakeholder process to establish the policies, culture and infrastructure that will be necessary to encourage and facilitate sharing this data.
I can’t emphasize enough the need to change the culture surrounding the (lack of) disclosure of trial data. Ben Goldacre has been working hard for years to encourage the release of clinical trials data, and he and the others supporting AllTrials.net certainly welcome the recommendations in the report (AllTrials wants all past and present clinical trial data to be registered and their full methods and summary reports reported). This report recommends disclosing the full trial data set (with metadata) within 18 months after study completion, and the trial data associated with any publication results should be released within 6 months of publication.
The report identifies current gaps in the clinical trial data environment that need to be filled in order to facilitate more data sharing. Current infrastructure needs to be improved to more efficiently store and manage the breadth of data. Technology is, at present, is not interoperable enough, to facilitate data sharing, nor are existing systems easily searchable or discoverable. There aren’t enough workers trained in data sharing to meet the increased demand, and more equitable cost-sharing mechanisms are needed in order for those burdens to not prevent participation
Increased data sharing can provide a greater return on investment, improve the drug development process, facilitate innovation and reduce redundant investigations. The benefits of making this information widely available outweigh the advantages some parties enjoy from keeping information to themselves. But making such sharing easier will take time. The sponsors of the report (a combination of global pharmaceutical companies, foundations and biomedical agencies from the U.S. and the U.K.) should start working on how to best implement its recommendations.