By Nancy L. Geller
From points of early trials to advanced modeling difficulties, this beneficial reference summarizes present technique utilized in the layout and research of medical trials. Chapters are contributed through across the world respected methodologists skilled in scientific trials perform.
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Extra info for Advances in Clinical Trial Biostatistics
INTRODUCTION Clinical trials in humans generally progress from dose ﬁnding trials (phase I) to ﬁrst trials of eﬃcacy (phase II) to deﬁnitive trials of eﬃcacy (phase III). In the interest of making development of clinical therapy more eﬃcient, we propose combining phase I and II trials so that once dose ﬁnding is completed, patients can continue entry at that dose, and the ﬁrst assessment of eﬃcacy can be made. The concept itself is simple, * Nancy L. Geller, Dean Follmann, and Eric Leifer wrote this chapter in their private capacity.
Continual reassessment method: A practical design for phase I clinical trials in cancer. Biometrics 46:33–48. Copyright n 2004 by Marcel Dekker, Inc. All Rights Reserved. , Shen, L. (1996). Continual Reassessment Method: A likelihood approach. Biometrics 52:673–684. , Whitehead, J. (1999). A novel Bayesian decision procedure for early-phase dose-ﬁnding studies. Journal Biopharm Statistics 9:583–597. Penta, J. , Rosner, G. , Trump, D. L. (1992). Choice of starting dose and escalation for phase I studies of antitumor agents.
In addition to being a means to design a phase I trial, Bayesian procedures provide a useful summary of all the information available at any time in the trial. For example, the precision with which the phase II dose has been determined can be reﬂected through the highest posterior density (HPD) credible interval for the MTD. The HPD credible interval is constructed so that it contains the most likely values for the target dose and so that the posterior probability that it contains the true MTD is equal to a speciﬁed credibility level y.
Advances in Clinical Trial Biostatistics by Nancy L. Geller