European committee adopts clinical trial legislation
The European Parliament Committee on the Environment, Public Health and Food Safety (ENVI) adopted an amended draft proposal of legislation that would make it easier for sponsors to conduct multinational clinical trials in Europe. The (see BioCentury Extra, July 17, 2012).
In a statement, the European Federation of Pharmaceutical Industries and Associations (EFPIA) said trial reports include patient data that is sensitive and in many cases commercially confidential. The association said the release of such data undermines incentives for development. EFPIA also said access to all patient-level data without any scientific standards runs the risk that non-scientific analyses will create public health scares and undermine assessments by regulatory authorities. ...