By Nancy L. Geller
From points of early trials to advanced modeling difficulties, this beneficial reference summarizes present method utilized in the layout and research of scientific trials. Chapters are contributed by way of the world over respected methodologists skilled in scientific trials perform.
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Additional resources for ADVANCES IN CLINICAL TRIAL B IOSTATISTI CS
80. The rationale is that it is often attractive to investigators to minimize sample size when the treatment is unsuccessful, but that sample size is less of concern when the treatment is successful. Patients were to be entered in two stages, with the ﬁrst (minimum) dose level of the preparative regimen stopped after the ﬁrst stage if there were not a suﬃcient number of engraftments. If, among the ﬁrst 9 patients treated, 7 or fewer engrafted, H0 would be accepted and the trial would stop. Thus we could stop with as few as two failures, even if they were the ﬁrst two patients entered into the trial.
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. Moller, S. (1995). An extension of the continual reassessment methods using a preliminary up-and-down design in a dose ﬁnding study in cancer patients, in order to investigate a greater range of doses.
It is important to note that by not requiring the speciﬁcation of a parametric curve relating the toxicity probabilities of diﬀerent dose combinations, this approach eliminates the need to model any synergism or interaction between the agents. Kramar et al. (1999) describe the application of CRML in a phase I trial to determine the MTD of the combination of docetaxel and irinotecan. The method is based on the discrete empiric model given by Eq. (6). Use of this model requires a procedure for obtaining a prior estimate of the probability of DLT at each of the k dose combinations preselected for use in the trial.