Continual Reassessment Method: A Practical Design for Phase 1 Clinical Trials in Cancer

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ID: 292000
1990
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Abstract
This paper looks at a new approach to the design and analysis of Phase 1 clinical trials in cancer. The basic idea and motivation behind the approach stem from an attempt to reconcile the needs of dose-finding experimentation with the ethical demands of established medical practice. It is argued that for these trials the particular shape of the dose toxicity curve is of little interest. Attention focuses rather on identifying a dose with a given targeted toxicity level and on concentrating experimentation at that which all current available evidence indicates to be the best estimate of this level. Such an approach not only makes an explicit attempt to meet ethical requirements but also enables the use of models whose only requirements are that locally (i.e., around the dose corresponding to the targeted toxicity level) they reasonably well approximate the true probability of toxic response. Although a large number of models could be contemplated, we look at a particularly simple one. Extensive simulations show the model to have real promise.
Reference Key
openalex_W2076108528 Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors John O’Quigley, Margaret S. Pepe, Lloyd D. Fisher
Journal biometrics
Year 1990
DOI
10.2307/2531628
URL
https://doi.org/10.2307/2531628
Keywords Keywords not found

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