By Nancy L. Geller
From features of early trials to advanced modeling difficulties, this helpful reference summarizes present technique utilized in the layout and research of scientific trials. Chapters are contributed by means of the world over respected methodologists skilled in medical trials perform.
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Extra resources for ADVANCES IN CLINICAL TRIAL B IOSTATISTI CS
1998). The value selected for the feasibility bound will determine the rate of change in dose level between successive patients. Low values will result in a cautious escalation scheme with relatively small increments in dose, while high values would result in a more aggressive escalation. 5. The rationale behind this approach is that uncertainty about the MTD is highest at the onset of the trial and a small value of a aﬀords protection against the possibility of administering dose levels much greater than the MTD.
Uncertainty about N is reﬂected through the posterior distribution and the expected loss associated with each permissible dose x is determined by averaging the loss attributed to x over the parameter space G Â V according to the posterior distribution C k. Thus, after k patients have been observed, the posterior expected loss associated with dose x 2 S is Z ELk ðxÞ ¼ Lðx; uÞ C kðuÞdu H and the next patient would receive the dose xkþ1 ¼ arg minfELk ðxÞg: x2S Copyright n 2004 by Marcel Dekker, Inc.
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.
ADVANCES IN CLINICAL TRIAL B IOSTATISTI CS by Nancy L. Geller