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.
Biometrics is a scientific journal emphasizing the role of statistics and mathematics in the biological sciences. Its object is to promote and extend the use of mathematical and statistical methods in pure and applied biological sciences by describing developments in these methods and their applications in a form readily assimilable by experimental scientists. JSTOR provides a digital archive of the print version of Biometrics. The electronic version of Biometrics is available at http://www.blackwell-synergy.com/servlet/useragent?func=showIssues&code;=biom. Authorized users may be able to access the full text articles at this site.
The International Biometric Society is an international society for the advancement of biological science through the development of quantitative theories and the application, development and dissemination of effective mathematical and statistical techniques. The Society welcomes as members biologists, mathematicians, statisticians, and others interested in applying similar techniques.
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