The value proposition in clinical trials: a framework for drug development

Value can be introduced into the clinical drug development process by increasing the probability of success, and through product differentiation. Quality-by-design tools, expected in formulation optimization, are not common in trial design and program optimization. In this paper, I spotlight recent efforts to incorporate these methods and make suggestions for value-driven clinical development. Value-driven product development is introduced by noting the earlier history outside the pharmaceutical sector. A description of innovations in trial design and program structure highlights the recent focus on inserting value into the drug development process. Shrewdly designed trials can provide higher-quality data with fewer subjects and resources, a timelier basis, and more value for companies. There is a value in planning: plan for value.