The Institute of Medicine, part of the National Academy of Sciences, is urging sponsors -- both private and governmental -- of clinical trials to share detailed data from such trials with outside researchers.
Such a policy would create a culture where the sharing of data is the expected norm, and would lead to accountable strategies aimed at maximizing the benefits of such trials while minimizing the risks, a report from the IOM says.
As part of efforts to widen access, clinical trial sponsors should develop specific processes for sharing data, such as allowing access via third-party websites, and adopting IOM-recommended time tables for the release of both summary results and complete data results in a timely fashion following the end of the trials, the IOM is recommending.
Clinical trials, vital for assessing if new health developments including drugs, vaccines and therapies are effective and safe, generate massive amounts of data yet a significant percentage is never published in peer-reviewed medical journals, the IOM points out.
The sharing of such clinical trial data is in the public interest because it can promote new discoveries and advance health care by maximizing knowledge gained from data collected during trials, the IOM committee writing the recommendations says.
It could stimulate new ideas for research and avoid unnecessarily duplicated trials, it adds.
"The sharing of clinical trial data needs to be carried out in a way that maintains incentives for sponsors and researchers to develop new clinical trials and therapies and that sustains patients' willingness to participate in them," said committee chair Bernard Lo. "Our recommendations attempt to balance the interests of different stakeholders with the public interest in having the best information possible regarding the effectiveness and safety of therapies."
On the same day as the IOM report was released, healthcare giant Johnson & Johnson announced it has arranged to make clinical trial data concerning its diagnostic tests and medical devices available to outside researchers in collaboration with Yale University.
Johnson & Johnson has been sharing data about its drugs through the Yale Open Data Access Project since last year, and said adding diagnostics and devices to the agreement was a way of deepening that commitment.
Trial data generated since the beginning of 2014 will be made available, the company says.
"We really believe that to advance science and to advance medical care, we wanted to take the next step," said chief medical officer Dr. Joanne Waldstreicher.
