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By Nancy L. Geller

From features of early trials to complicated modeling difficulties, this helpful reference summarizes present method utilized in the layout and research of scientific trials. Chapters are contributed by way of across the world respected methodologists skilled in scientific trials perform.

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Johnson, N. , Balakrishnam, N. (1995). Continuous Univariate Distributions. New York: John Wiley. , Candalh, E. (1999). Continual reassessment methods in phase I trials of the combination of two drugs in oncology. Statistics in Medicine 18:1849–1864. McCullagh, P. (1980). Regression models for ordinal data (with discussion). Journal of the Royal Statistical Society 42:109–142. , Daugherty, C. (1994). Physician-determined patient risk of toxic effects: impact on enrollment and decision making in phase I cancer trials.

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. Eichhorn, B. , Zacks, S.

Thus we could stop with as few as two failures, even if they were the first two patients entered into the trial. In that case, the preparative regimen would be escalated to the second dose level. However, if at least 8 patients engrafted at the first dose level, up to 20 additional patients would be enrolled at that dose. If there were three failures (even before all 20 additional patients were enrolled), we would stop using the first preparative regimen, in this case accepting H0, and the dose of the preparative Copyright n 2004 by Marcel Dekker, Inc.

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