Adaptive Design Clinical Trials: A Statistical and Programming Perspective (303270)

Keywords: adaptive design, clinical trials, statistics, programming

Since clinical trials form >60% of the cost of drug development, the FDA along with several stakeholders released the “Critical Path Opportunities List” of specific activities that would help speed the development and approval of medical products. Amongst other activities, it calls for adoption of innovative trial designs that use prior knowledge or accumulated data for trial design. An adaptive design is defined as “a study that includes a prospectively planned opportunity for modification of one or more specified aspects of the study design and hypotheses based on analysis of data (usually interim data) from subjects in the study.” Irrespective of all the benefits and positive reception by industry and regulatory agencies, the adoption rate of these designs remains relatively low. In this presentation, we discuss the advantages, drawbacks and challenges the industry faces in using adaptive design clinical trials from a statistical perspective.