Stallard, Nigel and Friede, Tim (2011) Efficiency of adaptive designs. In: Pong, Annpey and Chow, Shein-Chung, (eds.) Handbook of adaptive designs in pharmaceutical and clinical development. Boca Raton: CRC Press. ISBN 9781439810163

Abstract

This comprehensive guide offers a unified presentation of the principles and methodologies in adaptive design and analysis. It gives a well-balanced summary of current regulatory perspectives and recently developed statistical methods in this area. The handbook provides some insight regarding early phase and later phase adaptive designs. With a focus on the implementation of adaptive methods in clinical trials, it introduces the concepts of role, responsibility, function, and activity of a data safety monitoring board (DSMB) when applying these methods. Other important topics covered in detail include regulatory perspectives and logistics issues in applying adaptive design methods.

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