BioCentury
ARTICLE | Politics & Policy

EC seeking comments on clinical data disclosure

December 14, 2012 2:02 AM UTC

The European Commission is seeking comments from stakeholders on clinical trials in the EU, including how clinical trial data could be "made more open to scrutiny" and evidence regarding claims that pharmas selectively withhold data from patients and physicians. The move follows an EMA workshop in November in which advocates called for an open access model of trial data disclosure to allow independent entities to analyze and interpret data and to deter pharmas from reporting biased analyses. At the meeting, industry asked EMA to restrict access to patient-level clinical trial data through a gatekeeping mechanism (see BioCentury, Dec. 10). ...