OPTIMAL 2-STAGE DESIGNS FOR PHASE-II CLINICAL-TRIALS
OPTIMAL 2-STAGE DESIGNS FOR PHASE-II CLINICAL-TRIALS
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DOI：
10.1016/0197-2456(89)90015-9
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发表时间：
1989-03-01
期刊：
影响因子：
--
通讯作者：
SIMON, R
中科院分区：
文献类型：
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作者：
SIMON, R
The primary objective of a phase II clinical trial of a new drug or regimen is to determine whether it has sufficient biological activity against the disease under study to warrant more extensive development. Such trials are often conducted in a multiinstitution setting where designs of more than two stages are difficult to manage. This paper presents two-stage designs that are optimal in the sense that the expected sample size is minimized if the regimen has low activity subject to constraints upon the size of the type 1 and type 2 errors. Two-stage designs which minimize the maximum sample size are also determined. Optimum and "minimax" designs for a range of design parameters are tabulated. These designs can also be used for pilot studies of new regimens where toxicity is the endpoint of interest.
