The Current Drug Development Paradigm: Responding to US and European Demands for Evidence of Comparative Effectiveness and Relative Effectiveness
Published on Apr 1, 2014
· DOI :10.2139/SSRN.2637916
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.