By Nancy L. Geller
From features of early trials to complicated modeling difficulties, this beneficial reference summarizes present technique utilized in the layout and research of scientific trials. Chapters are contributed via the world over respected methodologists skilled in medical trials perform.
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Extra resources for ADVANCES IN CLINICAL TRIAL B IOSTATISTI CS
1999) describe how the estimates can be obtained prior to the onset of the phase I trial by using data from trials investigating each agent separately. Once these estimates have been obtained, the multiple agent trial can proceed according to CRML exactly as it applies to a single agent trial. 7. Incorporation of Covariate Information As deﬁned above, the MTD may well quantify the average response of a speciﬁc patient population to a particular treatment, but no allowance is Copyright n 2004 by Marcel Dekker, Inc.
Optimal Bayesian design applied to logistic regression experiments. Journal of Planning and Inference 21:191–208. Chevret, S. (1993). 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.
The stopping rule was assessed by simulation. 40. We concluded that the likelihood of stopping was satisfactory to protect patient safety for 100 day TRM. It is important to undertake simulations to evaluate the repeated sampling behavior of planned stopping rules in order to feel comfortable about their performance. S+ programs for Bayesian stopping rules and their assessment are available from the authors. 4. A PHASE II TRIAL DESIGN WITH AN INTERMEDIATE ENDPOINT AND BAYESIAN STOPPING RULES FOR EARLY FAILURE Several phase I/II PBSC transplantation clinical trials were designed for diﬀerent diseases using the paradigm above.
ADVANCES IN CLINICAL TRIAL B IOSTATISTI CS by Nancy L. Geller