Download PDF by Nancy L. Geller: Advances in Clinical Trial Biostatistics

By Nancy L. Geller

ISBN-10: 0824790324

ISBN-13: 9780824790325

From elements of early trials to complicated modeling difficulties, this beneficial reference summarizes present method utilized in the layout and research of scientific trials. Chapters are contributed by means of the world over respected methodologists skilled in medical trials perform.

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Uk], where ui = Prob{DLTjDose = di}. It is important to note that by not requiring the specification of a parametric curve relating the toxicity probabilities of different dose combinations, this approach eliminates the need to model any synergism or interaction between the agents. Kramar et al. (1999) describe the application of CRML in a phase I trial to determine the MTD of the combination of docetaxel and irinotecan. The method is based on the discrete empiric model given by Eq. (6). Use of this model requires a procedure for obtaining a prior estimate of the probability of DLT at each of the k dose combinations preselected for use in the trial.

All Rights Reserved. Bayesian Methods for Cancer Phase I Clinical Trials 21 MTD. Specifically, after k patients have been observed, the dose for the next patient accrued to the trial is xkþ1 ¼ FkÀ1 ðaÞ ð11Þ where Z xZ Fk ðxÞ ¼ 0 Y X k ðg; NÞ dN dg ð12Þ is the marginal posterior CDF of the MTD given Dk. Thus, subsequent to the first cohort of patients, the dose selected for each patient corresponds to the dose having minimal posterior expected loss with respect to Lðx; NÞ ¼ 8 < aðg À xÞ if x V g ði:e:; if x is an underdoseÞ : ð1 À aÞðx À gÞ if x > c ði:e:; if x is an overdoseÞ: The use of this loss function implies that for any y > 0 the loss incurred by treating a patient at y units above the MTD is (1 À a)/a times greater than the loss associated with treating the patient at y units below the MTD.

QUEST: A Bayesian adaptive psychometric method. Perception and Psychometrics 33:113–120. Whitehead, J. (1997). Bayesian decision procedures with application to dosefinding studies. International Journal of Pharmaceutical Medicine 11:201– 208. Wooley, P. , Schein, P. S. (1979). Methods of Cancer Research. New York: Academic Press. , Babb, J. (1998). Optimal Bayesian-feasible dose escalation for cancer phase I clinical trials. Statistics and Probability Letters 38:215– 220. Copyright n 2004 by Marcel Dekker, Inc.

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Advances in Clinical Trial Biostatistics by Nancy L. Geller

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