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

By Nancy L. Geller

From points 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 via across the world respected methodologists skilled in medical trials perform.

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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.

First, it is a ‘‘natural’’ conjugate prior for the binomial distribution; that is, the likelihood functions for both the beta and the binomial distributions have the same functional form (Berger, 1985). Thus, the posterior distribution may be easily recalculated each time a patient is evaluated. Second, using a beta prior has the following attractive property: Suppose a beta prior distribution with parameters a and b is used, and so its mean is a/(a +b) and variance is ab/[(a + b)2 (a + b+ 1)].

The continual reassessment method in cancer phase I clinical trials: A simulation study. Statistics in Medicine 12:1093–1108. Conaway, M. , 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.

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