A COMPARISON OF 2 PHASE-I TRIAL DESIGNS

被引:177
作者
KORN, EL
MIDTHUNE, D
CHEN, TT
RUBINSTEIN, LV
CHRISTIAN, MC
SIMON, RM
机构
[1] INFORMAT MANAGEMENT SERV INC,SILVER SPRING,MD 20904
[2] NCI,INVEST DRUG BRANCH,BETHESDA,MD 20892
关键词
D O I
10.1002/sim.4780131802
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
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.
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页码:1799 / 1806
页数:8
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