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 way of the world over respected methodologists skilled in medical trials perform.
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To deﬁne a unique MTD and implement design methods appropriate for single agent regimens, attention was restricted to a set S of dose combinations lying along the line segment delimited by the points (x, y) = (40, 6) and (x, y) = (180, 20). Since for any (x, y) 2 S the level of one agent is completely determined by the level of the other, the design methods described above for single agent trials can be used to select dose combinations in the multiple agent trial. As an example, Flournoy (1993) considered a design wherein k patients are to be treated at each of six equally spaced dose combinations to be selected from the set S deﬁned above.
Copyright n 2004 by Marcel Dekker, Inc. All Rights Reserved. 2 Design of Early Trials in Stem Cell Transplantation: A Hybrid Frequentist-Bayesian Approach* Nancy L. Geller and Eric S. A. A. Shelly L. A. 1. INTRODUCTION Clinical trials in humans generally progress from dose ﬁnding trials (phase I) to ﬁrst trials of eﬃcacy (phase II) to deﬁnitive trials of eﬃcacy (phase III). In the interest of making development of clinical therapy more eﬃcient, we propose combining phase I and II trials so that once dose ﬁnding is completed, patients can continue entry at that dose, and the ﬁrst assessment of eﬃcacy can be made.
To monitor day 100 TRM, we adopted a Bayesian approach which formally incorporated ‘‘prior’’ expectations about the proportion of patients experiencing TRM. Several authors have used Bayesian methods in other settings. Thall and Simon (1994) discuss Bayesian guidelines for phase II trials where comparison to a previously established standard will be made and the data are monitored continuously. , (1995) discuss Bayesian sequential monitoring in phase II trials with multiple outcomes. Follmann and Albert (1999) discuss Bayesian monitoring with censored data.
ADVANCES IN CLINICAL TRIAL B IOSTATISTI CS by Nancy L. Geller