Volume 13, Issue 18
Article

A comparison of two phase I trial designs

Edward L. Korn

Biometric Research Branch, EPN‐739, National Cancer Institute, Bethesda, MD 20892, U.S.A.

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Douglas Midthune

Information Management Services, Silver Spring, MD 20904, U.S.A.

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T. Timothy Chen

Biometric Research Branch, National Cancer Institute, Bethesda, MD 20892, U.S.A.

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Lawrence V. Rubinstein

Biometric Research Branch, National Cancer Institute, Bethesda, MD 20892, U.S.A.

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Michaele C. Christian

Investigational Drug Branch, National Cancer Institute, Bethesda, MD 20892, U.S.A.

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Richard M. Simon

Biometric Research Branch, National Cancer Institute, Bethesda, MD, 20892, U.S.A.

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First published: 30 September 1994
Citations: 216

Abstract

Phase I cancer chemotherapy trials are designed to determine rapidly the maximum tolerated dose of a new agent for further study. A recently proposed Bayesian method, the continual reassessment method, has been suggested to offer an improvement over the standard design of such trials. We find the previous comparisons did not completely address the relative performance of the designs as they would be used in practice. Our results indicate that with the continual reassessment method, more patients will be treated at very high doses and the trials will take longer to complete. We offer some suggested improvements to both the standard design and the Bayesian method.

Number of times cited according to CrossRef: 216

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