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

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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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.

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