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A comparison of two phase I trial designs
Author(s) -
Korn Edward L.,
Midthune Douglas,
Chen T. Timothy,
Rubinstein Lawrence V.,
Christian Michaele C.,
Simon Richard M.
Publication year - 1994
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.4780131802
Subject(s) - bayesian probability , maximum tolerated dose , computer science , clinical trial , clinical study design , phase (matter) , statistics , medicine , mathematics , artificial intelligence , chemistry , organic chemistry
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.