Access to Patient-Level Trial Data

To the Editor: The Chief Medical Officers Roundtable (CMOR), of which we are members, welcomes the Perspective article by Eichler et al. (Oct. 24 issue),(1) who are representatives of the European Medicines Agency (EMA), on access to patient-level trial data. CMOR formulates positions on medical topics, and its members include chief medical officers of major biopharmaceutical companies. CMOR supports a transparent, harmonized process for access to patient-level clinical trial data. Any approach to clinical trial data sharing must be in the interest of patients. Data sharing should be based on two tenets. First, principles should apply uniformly to all who ...