Expanding access to clinical trial data responsibly
"A new report by researchers from Harvard University and others in a working group convened by the Multi-Regional Clinical Trials Center (MRCT) at Harvard proposes recommendations for addressing a problem that has vexed drug regulators: how to expand public access to data from clinical trials while protecting patients' privacy and weighing pharmaceutical companies' business interests. Recently, the European Medicines Agency (EMA) announced it will provide public access to participant-level data submitted in applications for marketing approval in Europe, prompting questions about whether the U.S. Food and Drug Administration should follow suit. Data releases by the EMA have spurred litigation by drug companies and heated debate about whether clinical trial data should be protected as proprietary information or widely shared ... According to the authors, expanding access to participant-level data could both serve as a check on trial sponsors' characterizations of a product's safety and effectiveness, as well as open up new avenues of scientific inquiry beyond the scope of the original study. However, there are concerns that research participants' identities could be discovered, and that competitors and others could use the data to produce flawed analyses. The FDA historically has treated participant-level clinical trial data submitted to the agency as confidential. The authors recommend that a system of expanded access to clinical trial data apply to trials of all approved prescription drugs, medical devices, and biologics; and treat all trial sponsors and qualified data requesters evenhandedly. It should have mechanisms to ensure that all sponsors and data users adhere to minimum standards -- for example, rules should specify what must be shared, and data users should commit to following a scientifically sound analytical plan. If sponsors are permitted to influence which data requests get granted, they should be required to apply explicit decision criteria and publicly explain the reasons for denials. Using an independent intermediary organization to make those decisions, however, may be preferable ..."