Boston, MA 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.
The report, published online October 21, 2013 in The New England Journal of Medicine, was released to coincide with the first meeting of the Institute of Medicine's Committee on Strategies for Responsible Sharing of Clinical Trial Data on October 23. The Institute of Medicine convened the committee on an accelerated timetable to develop a framework for expanded public access to clinical trial data. An initial report is expected in January 2014.
"Our experiences with Vioxx, Avandia, and other widely prescribed drugs that were revealed to have serious safety risks show how important it is to give independent scientists access to clinical trial data," said Michelle Mello, professor of law and public health at the Harvard School of Public Health and lead author of the report. "The question is, how can we achieve the powerful public health benefits of data sharing while protecting research participants' privacy, avoiding 'junk science,' and minimizing burdens on trial sponsors?"
According to the authors, expanding access to participant-level data could both serve as a check on trial sponsors' character
|Contact: Marge Dwyer|
Harvard School of Public Health