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SPEAKER: |
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TITLE: |
"Up-and-down designs for toxicity studies" |
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DAY: |
Monday, September 18, 2000 |
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TIME: |
2:30 p.m. [Coffee & cookies in BSB-202 at 3:30 p.m.] |
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PLACE: |
BSB-B103 |
Up-and-Down Designs are procedures in which the next dose is never more than one level distant from the current one. Such procedures are attractive in clinical investigations in which cautious movement in the treatment space is desirable. Let X(n) denote the treatment given to the nth patient, and assume that the possible treatments are an ordered finite set {x1 <x2< ... <xK}. Let Y(n)=1 if a toxic response is observed by the nth patient, and let Y(n)=0 if no toxicity is observed. We assume P{Y(n)=1| X(n)= xk} is an increasing function of k, k=1, ... ,K. Given a specified target toxicity rate, we describe a Biased Coin Up-and-Down procedure that causes treatments to be clustered about the dose having that unknown toxicity rate. We also discuss the role of such designs, and of toxicity studied in general, in the drug development cycle.
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Nancy Flournoy is Professor, Department of Mathematics and Statistics, College of Arts and Sciences, American University, Washington, DC. She holds a BS and MS in Biostatistics from UCLA and a PhD in Biomathematics from the University of Washington. Her research interests include adaptive sequential design, chemometrics, clinical trials, and statistical immunology. |
The references below, suggested by the speaker as useful background for this talk, have been placed on reserve at Thode Library (STATS 770: Statistics Seminar).
Durham, S.D. & N. Flournoy (1994) Random walks for quantile estimation. In Statistical Decision Theory and Related Topics V, S.S. Gupta & J.O. Berger (eds), pp 467-476. New York: Springer-Verlag.
Durham, S.D., N. Flournoy & A.A. Montazer-Haghighi (1993) Up-and-down-designs. In Computing and Statistics: Interface 23, M.E. Tarter & M.D. Lock (eds), pp 375-384.
