The Institute of Medicine has issued a new report on ways to best share clinical trial data. The report was commissioned by the US National Institutes of Health and other sponsors.
"Responsible sharing of clinical trial data will allow other investigators to carry out additional analyses and reproduce published findings, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials," the report says.
However, there are a number of challenges to sharing data such as protecting the privacy of participants, complying with consent obtained from participants, preserving the economic interests of trial sponsors, giving recognition to researchers who planned and ran the trial, and more.
The IOM report outlines a number of recommendations for researchers, their institutions, regulators, and journals, among others, to implement that will "maximize the benefits and minimize the risks associated with data sharing."
Foremost, it recommends that summary-level results from clinical trials should be shared within 12 months after the trial's end and a "full data package" should be shared within 18 months, unless the trial is supporting a regulatory application. In that case, the data should be shared within 30 days of regulatory approval or 18 months from the trial's end, whichever is later.
Additionally, it says that stakeholders need to nurture an environment in which such data sharing is the norm. Funders and sponsors, it says, could provide funding for clinical trial data sharing as a line item in their grants and contracts, and could weigh prior data sharing by investigators as part of future funding decisions.
Meanwhile, researchers themselves could design trials with the expectation of sharing the resulting data, inform participants during the consent process about what will and will not be shared, and make such data available in a timely manner.
"The report adds a welcome endorsement from the medical establishment that data sharing is not optional and the move toward open science in medical research is not a fad," Yale University's Harlan Krumholz, who heads the Yale Open Data Access project, tells Ed Silverman at the Wall Street Journal's Pharmalot blog. "There is little question now that the current approach, in which the results of studies of people are too often not reported and the data even less often shared, harms the integrity and trustworthiness of medical evidence."
However, the University of Maryland's Peter Doshi notes that these recommendations seem to be geared toward future clinical trials.
"While the report does not endorse the status quo, it focuses almost exclusively on practices related to future clinical trials, stating that sharing data from past trials will occur on a case-by-cases basis," adds Doshi, who is also a BMJ associate editor.