Perspectives on the use of adaptive designs in clinical trials. Part I. Statistical considerations and issues.

Abstract

With greater and enthusiastic interests in pursuing adaptive design clinical trials, the pharmaceutical industry as a whole is in the midst of gaining better understanding of scientifically sound approaches. In light of the public's greater interests, the Basel Biometric Section (BBS) of the Austo-Swiss Region of the International Biometric Society held a spring conference on "Perspectives on the Use of Adaptive Designs in clinical trials" at Basel University, Basel, Switzerland (March 12, 2010). The conference opened with statistical considerations and issues of adaptive designs in clinical trials, followed by a panel discussion in which international representatives from industry, academia, and regulatory agencies participated. In addition, six presentations were given by individual research groups mainly focusing on adaptive design methodologies, some illustrated with examples. There are two parts in this special article capturing the morning session of the conference. Part I summarizes the highlights given at the statistical considerations and issues session and is presented here. Part II, capturing the panelists' perspectives given at the panel discussion session, can be found immediately following Part I.