Novo to start releasing clinical study reports
Novo Nordisk A/S (CSE:NVO; NYSE:NVO) disclosed in its 3Q13 earnings that starting March 1, 2014, it will make clinical study reports publicly available for trials completed after Jan. 1, 2006, for products approved in both the U.S. and the EU. The company also said it will make available to researchers "with legitimate and valid research proposals" raw data from trials completed after 2001. Novo said it will create an independent panel to review requests. Novo is a member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), which along with the Pharmaceutical Research and Manufacturers of America (PhRMA) put out a proposal to voluntarily commit association members to make clinical trial data available to qualified researchers starting Jan. 1, 2014 (see BioCentury Extra, July 24).
An EMA data transparency policy that would provide controlled access to large parts of raw clinical trial data is slated to go into effect on Jan. 1, 2014. FDA is proposing to make patient-level data available that identifies the drug class but not the individual product (see BioCentury, July 22). ...