By Nancy L. Geller
From facets of early trials to complicated modeling difficulties, this beneficial reference summarizes present technique utilized in the layout and research of medical trials. Chapters are contributed through the world over respected methodologists skilled in medical trials perform.
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Extra resources for ADVANCES IN CLINICAL TRIAL B IOSTATISTI CS
Petroni, G. R. (1996). Designs for phase II trials allowing for a trade-oﬀ between response and toxicity. Biometrics 52:1375–1386. , Holdener, E. E. (1990). Responses and toxic deaths in phase I clinical trials. Annals of Oncology 1:175–181. Dent, S. , Eisenhauer, E. A. (1996). Phase I trial design: Are new methodologies being put into practice? Annals of Oncology 6:561–566. Dillman, R. , Koziol, J. A. (1992). Phase I cancer trials: Limitations and implications. Molecular Biotherapy 4:117–121.
Oxford University Press. , Chen, T. , Tyan, I. (2000). Designs for phase I cancer clinical trials with diﬀerentiation of graded toxicity. Communications in Statistics—Theory and Methods 29:975–987. Copyright n 2004 by Marcel Dekker, Inc. All Rights Reserved. Bayesian Methods for Cancer Phase I Clinical Trials 39 Watson, A. , Pelli, D. G. (1983). QUEST: A Bayesian adaptive psychometric method. Perception and Psychometrics 33:113–120. Whitehead, J. (1997). Bayesian decision procedures with application to doseﬁnding studies.
As a speciﬁc example, they consider the case where DLT is deﬁned as either a grade 3 or grade 4 toxicity. The extension requires the speciﬁcation of a probability u*, which is strictly less than the target probability u used in the deﬁnition of the MTD. The authors propose the speciﬁc choice u* = u/w where the weight w reﬂects the relative seriousness of grade 3 and 4 toxicities. For example, if grade 4 is considered twice as serious or diﬃcult to manage as grade 3, then w = 2. Treatment response is still recorded as the binary indicator for DLT and no changes are made to the dose-toxicity model or prior distribution underlying CRM.