By Nancy L. Geller

ISBN-10: 0824790324

ISBN-13: 9780824790325

From features of early trials to advanced modeling difficulties, this helpful 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 resources for Advances in Clinical Trial Biostatistics**

**Example text**

1990). 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.

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.

Bayesian Methods for Cancer Phase I Clinical Trials 29 and spacing of the dose combinations and so deﬁne the set of dose combinations to be used in the trial. This approach can easily be generalized to accommodate either nonlinear search regions or combinations of more than two agents. For example, the set S of dose levels to be searched for an MTD could be chosen so that given any two distinct dose combinations in S, one will have the levels of all agents higher than the other. As a result, the combinations in S can be unambiguously ordered and the dose-toxicity relationship can be meaningfully modeled as an increasing function of the distance of each permissible dose combination from the ‘‘minimum’’ combination.

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