|
Abstract:
|
As the traditional drug development paradigm becomes increasingly less sustainable given today's challenges and expectations for the future, regulatory agencies and pharmaceutical developers are taking steps in support of modernizing and increasing the efficiency of drug development. Adaptive clinical trial designs have received much recent attention, holding considerable promise as a means of improving efficiency. In parallel, structured decision analysis as a discipline in its own right has the potential for more widespread application in clinical development than is currently witnessed. We highlight the natural connection between principles underlying both adaptive design and decision analysis, and offer practical examples of the synergistic application of these two methodological frameworks, emphasizing that the latter may be seen as an enabling tool for the former.
|
