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Dose-finding designs: the role of convergence properties.

Authors
  • Oron, Assaf P
  • Azriel, David
  • Hoff, Peter D
Type
Published Article
Journal
The international journal of biostatistics
Publication Date
Jan 01, 2011
Volume
7
Identifiers
DOI: 10.2202/1557-4679.1298
PMID: 22718676
Source
Medline
License
Unknown

Abstract

It is common for novel dose-finding designs to be presented without a study of their convergence properties. In this article we suggest that examination of convergence is a necessary quality check for dose-finding designs. We present a new convergence proof for a nonparametric family of methods called "interval designs," under certain conditions on the toxicity-frequency function F. We compare these conditions with the convergence conditions for the popular CRM one-parameter Phase I cancer design, via an innovative numerical sensitivity study generating a diverse sample of dose-toxicity scenarios. Only a small fraction of scenarios meet the Shen-O'Quigley convergence conditions for CRM. Conditions for "interval design" convergence are met more often, but still less than half the time. In the discussion, we illustrate how convergence properties and limitations help provide insight about small-sample behavior.

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