Public Access to Clinical Trials Data: Draft European Medicines Agency (EMA) Policy, issued June 24, 2013, and FDA Request for Comments, issued June 4, 2013

Practices: Health Care


On June 24, 2013, the EMA released a draft policy providing for wide researcher access to many types of clinical trials data that are submitted to the EMA by industry to support marketing applications. These data include participant-level clinical study data, as well as clinical study reports.
The policy, or some version of it, will likely become effective on January 1, 2014. This draft is the result of the deliberations between January and April 2013 of five separate advisory groups to the EMA, which were composed of experts from the pharmaceutical industry, academia, public health groups, and patient advocacy organizations. This teleconference will provide a summary of the new EMA draft policy, trace the course of its development, and discuss its probable impacts on the planning and conduct of clinical research.
On June 4, 2013, the U.S. FDA issued a request for public comments on its own proposed version of expanded access to clinical trials data, including participant-level data. This audioconference will also address the FDA’s preliminary proposal, and how it differs in significant ways from that of the EMA.
Topics addressed will include:
• The scope of the EMA draft policy and the FDA proposal in terms of which organizations and which categories of clinical trials data are covered
• The process by which clinical trials data will be made publicly available under the EMA proposal
• Efforts to protect the privacy of clinical trials participants
• The interaction between wider sharing of clinical trials data and the informed consent process
• The EMA’s and FDA’s consideration of the commercial and industry interests involved in data sharing
• Potential impacts on the regulatory processes of the EMA, FDA and similar national drug approval authorities
• Questions left unanswered by the EMA draft policy and the FDA proposal
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