The Institute of Medicine's new report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk proposes that sharing clinical trial data become the norm in the research community in order to encourage secondary analyses, strengthen the evidence for regulatory decisions, and maximize the contributions of trial participants.
A new report from the Institute of Medicine (IOM) recommends that sharing clinical trial data—supported by new technology platforms and shared funding—should become the norm in the medical research community to encourage secondary analyses and maximize trial participants' contributions.
Noting that a large proportion of clinical trial data is never published or made public, the authors of Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk propose a practical framework that provides incentives for researchers to share their results (available at http://iom.edu/Reports/2015/Sharing-Clinical-Trial-Data.aspx). They recommend specific strategies aimed at expanding access for other researchers and the public while protecting patient privacy and creating safeguards for sponsors' intellectual property. The IOM, the health arm of the National Academy of Sciences, assembled a committee of 14 experts in medical research and health policy to compile the report.
“Sharing allows others to reproduce published findings and carry out secondary analyses—and maximizes the contributions of participants and the effort and funding for trials,” said committee chair Bernard Lo, MD, president of the Greenwall Foundation in New York, NY, and former director of the Program in Medical Ethics at the University of California, San Francisco, at a press conference. “We think that the question today is not whether you share clinical trial data, but instead, what types of data do you share, when do share it, and how do you share it?”
Those details should be included in a data-sharing plan submitted when registering a clinical trial, the IOM report recommends. Upon study completion, summary results should be made available within 12 months, and complete data within 6 months of publication or no later than 18 months after the close of the trial. Full data on products submitted for regulatory approval should be published 30 days after approval, or within 18 months if the application for approval is abandoned.
To encourage investigators to make data available, various stakeholders could require data sharing as part of their agreements with researchers. For example, funders and sponsors could require it as a condition of funding, and medical journals could ask for a data-sharing plan when a manuscript is submitted for publication.
Investigators should also detail who should have access to the data and when, the committee recommends.
The committee notes several significant obstacles to achieving its recommendations, including developing compatible technology platforms to store and manage information. Success also hinges on establishing a sustainable funding model.
“Currently, a small subset of sponsors and funders of trials bear the full cost of clinical trial data sharing,” said Lo. “That's not a sustainable or fair model. We recommend that those who benefit from sharing clinical trial data should also bear a fair share of the cost.”
For more news on cancer research, visit Cancer Discovery online at http://CDnews.aacrjournals.org.