Phrma Working Group on Adaptive Designs: Introduction to the Full White Paper

Abstract

Pharmaceutical Research and Manufacturers of America (PhRMA) has formed a Working Group on Adaptive Designs. The group aims to contribute to a constructive dialogue on adaptive designs by engaging statisticians, clinicians, and other stakeholders in academia, regulatory agencies, and industry. Hopefully this will facilitate broader consideration and implementation of these designs. The papers that follow in this issue comprise the Full White Paper of the group and summarize its findings and recommendations from its first year of activity.