ADVANCES IN CLINICAL TRIAL B IOSTATISTI CS by Nancy L. Geller

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 via the world over respected methodologists skilled in medical trials perform.

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More specifically, the maximum likelihood estimate, uˆ k(x), of the probability of DLT at any dose x will be trivially equal to either zero or one, or perhaps even fail to exist, until at least one patient manifests DLT and one fails to exhibit DLT. Hence, the Copyright n 2004 by Marcel Dekker, Inc. All Rights Reserved. 24 Babb and Rogatko use of CRML must be preceded by an initial stage whose design does not require maximum likelihood estimation. , by original CRM) or by use of more traditional up-and-down schemes based on a modified Fibonacci sequence.

Statistics and Probability Letters 38:215– 220. Copyright n 2004 by Marcel Dekker, Inc. All Rights Reserved. 2 Design of Early Trials in Stem Cell Transplantation: A Hybrid Frequentist-Bayesian Approach* Nancy L. Geller and Eric S. A. A. Shelly L. A. 1. 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.

Cancer phase I clinical trials: Efficient dose escalation with overdose control. Statistics in Medicine 17:1103–1120. Babb, J. , Rogatko, A. (2001). Patient specific dosing in a cancer phase I clinical trial. Statistics in Medicine 20:2079–2090. , Larntz, K. (1989). Optimal Bayesian design applied to logistic regression experiments. Journal of Planning and Inference 21:191–208. Chevret, S. (1993). The continual reassessment method in cancer phase I clinical trials: A simulation study. Statistics in Medicine 12:1093–1108.

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