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By Nancy L. Geller

From elements of early trials to advanced modeling difficulties, this beneficial reference summarizes present method utilized in the layout and research of medical trials. Chapters are contributed via across the world respected methodologists skilled in medical trials perform.

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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. Journal of the National Cancer Institute 86:1685–1693.

Workshop on phase I study design. Annals of Oncology 7:567–573. ASCO special report. Critical role of phase I clinical trials in cancer treatment. Journal of Clinical Oncology 15:853–859. , Zacks, S. (1998). Cancer phase I clinical trials: Efficient dose escalation with overdose control. Statistics in Medicine 17:1103–1120. Babb, J. , Rogatko, A. (2001). Patient specific dosing in a cancer phase I clinical trial. Statistics in Medicine 20:2079–2090. , Larntz, K. (1989). Optimal Bayesian design applied to logistic regression experiments.

In this way, the expected number of patients given an inadequate dose of the preparative regimen is minimized. There are, of course, other ways in which phase I and II activities could be combined. Instead of Simon’s design, we have sometimes used Fleming’s (1982) design in the same fashion as described above. Fleming’s (1982) design allows early stopping to either accept or reject the null hypothesis. Since Fleming’s design is ultimately based on Wald’s (1947) sequential probability ratio test, it approximately minimizes expected sample sizes under the point-null and point-alternative hypotheses.

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