Optimal two-stage designs for phase II clinical trials with differentiation of complete and partial responses

Optimal two-stage designs for phase II clinical trials with differentiation of complete and partial responses
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DOI:
10.1080/03610920008832524
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发表时间:
2000-01-01
影响因子:
0.8
通讯作者:
Chen, TT
Chen, TT
中科院分区:
数学4区
文献类型:
--
作者:
Lin, SP;Chen, TT

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In the usual design and analysis of a phase II trial, there is no differentiation between complete response and partial response. Since complete response is considered more desirable this paper proposes a weighted score method which extends Simon's (1989) two-stage design to the situation where the complete and partial responses are differentiated. The weight assigned to the complete response is suggested by examining the likelihood ratio (LR) statistic for testing a simple hypothesis of a trinomial distribution. Both optimal and minimax designs are tabulated for a wide range of design parameters. The weighted score approach is shown to give more efficient designs, especially when the response probability is moderate to large.