Abstract

Drug development has many moving parts. Traditionally they are handled in a more sequential and segmented way. This has served us well due to relatively slow pace of drug development. As the pace of drug development becomes faster and faster, we need to think more in a holistic way. This is especially important due to the advancement of new technologies, which has upended the way how we generate and analyze data. We present a framework to identify integrated evidence opportunities in drug development and demonstrate these opportunities using some real examples. 

Keywords

integrated evidence strategy, RWE, drug development efficiency, optimal decision making, probability of success