As recognized by the FDA's Critical Path Opportunities Report, the need to develop and apply innovative approaches to create new trial designs and clinical development programs is rapidly rising. Such novel approaches hold tremendous potential in the ability to refine mechanisms lying at the fundamental core of product safety and efficacy such as rapid signal detection through frequent data examination and identification of different target populations.



Objectives:

Identify innovative approaches to creating trial designs and clinical development programs.

Evaluate the impact of adaptive trial designs on product safety and efficacy.

Assess the overall impact of adaptive trial designs in clinical development.