The Current Drug Development Paradigm: Responding to US and European Demands for Evidence of Comparative Effectiveness and Relative Effectiveness

Mestre-Ferrandiz, J., Deverka, P., Pistollato, M. and Rosenberg, E.

Occasional Paper
April 2014

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The project reported in this Occasional Paper was intended to determine how changing demands for evidence are affecting drug development in five global pharmaceutical companies: Amgen, Eli Lilly, GSK, Novartis and Sanofi-Aventis. A literature review helped elucidate concepts and define focus. The authors then conducted semi-structured interviews with an international sample of 19 senior pharmaceutical executives in various positions in the five companies: R&D, outcomes research, medical affairs, and pricing and reimbursement. The intent was to capture information about the effect of CER/RE requirements on the drug development process now and in the future.