IOM Report Calls for Clinical Trials Data Sharing as the Norm

Reported by: DANIEL S. LEVINE

The sharing of clinical trials data should be fostered according to a new report released January 14 from the Institute of Medicine, which called on industry, government, academia, and other stakeholders to work together to create both the culture and infrastructure needed to maximize the benefits and minimize the risks of sharing data.

Though the report provides guidelines for what clinical trial data should be shared and when, the IOM has no authority to implement or enforce the recommendations. It said that the 23 sponsors of the study should take the lead to convene a multi-stakeholder body with global reach and broad representation to address the key challenges associated with sharing clinical trial data. The U.S. National Institutes of Health, the U.S. Food and Drug Administration, the National Academy of Sciences, as well as 17 biopharmaceutical companies were among the report sponsors.

The issuance of the report follows policy and legal fights in Europe and the United States over the release of clinical trials data as a push toward greater transparency has accelerated. The AllTrials campaign, a group of journals, academic institutions, advocacy groups and others that have led a campaign for clinical trial data transparency, said it welcomes the IOM report, but says “its recommendations could have been stronger if they included clear pathways to implementation and calls for audits of compliance.”

Many pharmaceutical companies are concerned about data sharing for fear it could undermine their investment in research and development, weaken their competitive advantages, and create new liabilities. But there is a growing belief, particularly as an era of Big Data analytics emerges, that there is great public benefit to be realized in making the wealth of clinical trials data generated available to researchers.

“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,” says IOM committee chair Bernard Lo, president of the Greenwall Foundation. “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.”

During a webcast discussing the report, Lo noted that much of the data collected in clinical trials are not analyzed and not published in peer-reviewed journals in a timely manner. In fact, he estimated a third of clinical trials data are not published within four years after the completion of a study. That means the efforts of researchers, participants, and funders are going to waste. Data sharing, the report argues, can advance new discoveries and improve clinical care by maximizing the knowledge gained from data collected in trials, stimulating new ideas for research, and avoiding unnecessarily duplicative trials.

Francis Collins, director of the NIH, in a statement said the IOM report “presents thoughtful analysis and useful points to consider about how to promote responsible access to participant level data. “Through responsible data sharing, participants in clinical trials are assured that their contributions to research will have maximal effect, and researchers are able to accelerate efforts to prevent, detect, and treat disease by validating and advancing results,” he said.”

The report recommended that stakeholders foster a culture in which data sharing is the expected norm and should commit to responsible strategies aimed at maximizing the benefits and minimizing the risks of data sharing.

It also called on sponsors and investigators to share data in a timely manner including providing a full analyzable data set with metadata no later than 18 months after the completion of a study. In the case of data supporting a regulatory application, it sad data should be available no later than six months after publication.

Stakeholders should use operational strategies that include employing data use agreements, designating an independent review panel, including members of the lay public in governance, and making access to clinical trial data to mitigate the risks and enhance the benefits of sharing sensitive clinical trial data.

The report acknowledges there are both significant cultural and infrastructure challenges that need to be tackled. This includes the need to protect privacy and obtain consent of clinical trials participants, protecting commercially confidential information of sponsors, creating interoperable and searchable means of storing data, and not creating undo financial burdens for the holders of data to enable sharing.

“The rapidly changing landscape of clinical trials and the movement toward greater transparency create a need to establish professional standards and set expectations of how to share clinical trial data,” says Victor Dzau, president of the Institute of Medicine. “Numerous approaches and models for sharing clinical trial data are being implemented across the globe, and more and more organizations are taking the initiative to share their data. The time is right to have the principles in this report serve as a guide for what specific clinical trial data to share, at what time, and under what conditions.”

The full report can be downloaded for free from the IOM website at https://www.nap.edu/catalog/18998/sharing-clinical-trial-data-maximizing-benefits-minimizing-risk