The Institute of Medicine on Wednesday released four recommendations to address practices that often have left relevant medical research unpublished and useful data unattainable by independent researchers. The guidelines could represent a sea change in how the research enterprise is thinking about its responsibilities, say advocacy groups, ethicists and academic researchers.
The recommendations outline major changes to how results of medical studies are handled in the United States, including timetables for the sharing of adverse event summaries and analyzable data sets.
“The issue is no longer whether to share clinical trial data, but what specific data to share, at what time, and under what conditions,” wrote Dr. Bernard Lo, chair of the IOM committee on strategies for responsible sharing of clinical trial data, in his preface. The guidelines represent an attempt to balance the interests of stakeholders with the public demand for information on the effectiveness and safety of therapies, he said.
The first recommendation is that data sharing should be the expectation and the norm. Stakeholders in clinical trials are asked to foster a culture which promotes the development of a data sharing infrastructure, require data sharing plans as part of their protocol, and detail during the informed consent process what data will be available to participants during and after participation in a trial.
The second recommendation is for the full analyzable set of data from a given study to be available no later than 18 months after the study completion, with exceptions for trials intended to support regulatory application. The full data on newly approved products or drugs should be made available within 30 days of regulatory approval.
The next recommendation calls for the implementation of strategies to encourage data sharing, including the creation of technological platforms, boosting financial support, and creating incentives.
The fourth recommendation calls on sponsors of the study to take the lead on making all the recommendations happen.
While critics of past practices see the recommendations as a major change of tone, they still have concerns about whether they will translate into actual practice.
The guidelines would be a major step in the right direction, if they are implemented, but there is a major emphasis on the 'if ', said Dr. Michael Carome, director of the Health Research Group for Public Citizen. “Many times we have seen recommendations sit in a book on a shelf and never get implemented. That is all too common,” he said.
That concern was shared by Diane Zuckerman, president of the National Center for Health Research, a nonprofit research and advocacy organization. She also points to wording in the IOM report which would allow the exclusion of information that is considered confidential commercial information. “Like most proposals, the devil is in the details,” she says. "Based on the track record of companies and government regulators, essential information that no reasonable person would think is a trade secret is often redacted as trade secrets.”
“Based on the track record of companies and government regulators, essential information that no reasonable person would think is a trade secret is often redacted as trade secrets,” she says.
The IOM 249-page report acknowledges there are many challenges and considerations in tackling the complex issues, but that all stakeholders, from drug and device manufactures, to medical journals and regulatory bodies, have the responsibility to the public and to the voluntary participants in the trials.
“Although there are technical hurdles, we need to change how we think about data,” wrote Dr. Jeffrey Drazen, editor-in-chief of the New England Journal of Medicine and IOM committee member, in an editorial published Wednesday. “We need to view it as a community resource, much like a shared park, rather than as personal property.”
The IOM study was supported by the National Academy of Sciences, National Institutes of Health, Food and Drug Administration, as well as several drug and device manufacturers, including AbbVie, GlaxoSmithKline, Bayer, Pfizer Inc and Sanofi-Aventis, among others, many of whom already have been voluntarily seeking out collaborative efforts to share data over the past few years.
For example, in 2013 GlaxoSmithKline launched its data-sharing website clinicalstudydatarequest.com, which includes participation from Boehringer Ingelheim, Roche, Sanofi and ViiV Healthcare.
The website alltrials.net—launched last year in Europe by a group including BMJ, Cochrane the Dartmouth Institute for Health Policy & Clinical Practice— has requested that all past and present trials be registered and their results be reported.
Last January, Johnson & Johnson entered an agreement to share clinical trial data through the Yale School of Medicine's Open Data Access Project, which will serve as an independent body to review requests from investigators and physicians seeking access. Wednesday, that group announced that is it making available all clinical trial data for medical devices and diagnostics for Johnson & Johnson.
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