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www.fdanews.com/articles/146481-eu-regulators-detail-plan-to-boost-clinical-trial-raw-data-access

EU Regulators Detail Plan to Boost Clinical Trial Raw Data Access

May 16, 2012
Full clinical trial reports with raw data should be publicly available, but regulatory authorities must develop engagement and standards to ensure that meta- and re-analysis of data are of high quality, a group of European regulators says. Patients enroll in trials because they believe they’ll be contributing to wider medical knowledge, and keeping data commercially confidential undermines that contribution, officials from the European Medicines Agency, UK’s Medicines and Healthcare products Regulatory Agency, France’s Afssaps and the Netherlands’ Medicines Evaluation Board write.
International Pharmaceutical Regulatory Monitor