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Biostatistics Advance Access published online on October 9, 2006
Biostatistics, doi:10.1093/biostatistics/kxl031
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© 2006 The Authors This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/2.0/uk/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Received April 25, 2006
Revised September 1, 2006
Accepted October 3, 2006

Article

Screening designs for drug development

David Rossell 1, Peter Müller 2 *, and Gary L. Rosner 2

1 Department of Biostatistics & Applied Mathematics, The University of Texas, M. D. Anderson Cancer Center Houston, TX 77030, U.S.A; Department of Statistics, Rice University, Houston, TX 77005
2 Department of Biostatistics & Applied Mathematics, The University of Texas, M. D. Anderson Cancer Center Houston, TX 77030, U.S.A

* To whom correspondence should be addressed.
Peter Müller, E-mail: pmueller{at}mdanderson.org


  Abstract

We propose drug screening designs based on a Bayesian decision-theoretic approach. The discussion is motivated by screening designs for phase II studies. The proposed screening designs allow consideration of multiple treatments simultaneously. In each period new treatments can arise and currently considered treatments can be dropped. Once a treatment is removed from the phase II screening trial, a terminal decision is made about abandoning the treatment or recommending it for a future confirmatory phase III study. The decision about dropping treatments from the active set is a sequential stopping decision. We propose a solution based on decision boundaries in the space of marginal posterior moments for the unknown parameter of interest that relates to each treatment. We present a Monte Carlo simulation algorithm to implement the proposed approach.

We provide an implementation of the proposed method as an easy to use R library available for public domain download (http://www.stat.rice.edu/~rusi/ or http://odin.mdacc.tmc.edu/~pm/).


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