Phase II studies

• Published in: Bayesian Adaptive Methods for Clinical Trials pp. 155 - 210
• Main Authors: Berry, Scott M., Carlin, Bradley P., Lee, J. Jack, Muller, Peter
• Format: Book Chapter
• Language: English
• Published: United Kingdom CRC Press 2010; Taylor & Francis Group
• Subjects: BIOLOGY, LIFE SCIENCES; Clinical trials; Probability & statistics; PP; Stopping Rule; Phase IIB Trials; Posterior Distribution; Posterior Updating; Late Phase Studies; Phase IIA; Battle Trial; Dose Allocation; True Response Rate; Posterior Inference; Posterior Probabilities; Maximum Sample Size; AR; Adaptive Treatment Allocation; Locally Advanced Breast Cancer; Phase IIA Trial; Decision Boundaries; Software Note; Pr Pr; Allocation Probabilities; Expected Sample Size; Minimax Design; Simulation Truth

In this chapter we address the design and statistical considerations for the development of “middle phase” clinical trials, especially those associated with phase II cancer trials. Here the focus shifts from toxicity to efficacy, and trials are run on much larger groups of patients (say, 40 to 200)....