Recent report recommends expanded access to clinical trial data
Published November 04, 2013 by OSP
According to the authors of the report, 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.