Adaptive Design and Decision Analysis—Companions for Transforming Clinical Development

Abstract

Although the traditional drug development paradigm under which clinical testing proceeds in clearly defined, sequential phases has been a viable model for many years, it is becoming increasingly less sustainable given the challenges of today's environment and expectations for the future. Regulatory agencies as well as pharmaceutical developers are taking steps to support modernizing and increasing the efficiency of drug development. In the arena of clinical trial methodologies, adaptive designs have received much recent attention, holding considerable promise as a means of improving efficiency. In parallel, structured decision analysis as a discipline has the potential for more widespread application in clinical development than is currently witnessed. In this article, we highlight the natural connection that exists between the principles underlying both adaptive design and decision analysis. The latter may be seen as an enabling tool for the former and warrants consideration for more deliberate application at broader levels of drug development.