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      Optimal two-stage designs for phase II clinical trials

      Controlled Clinical Trials
      Elsevier BV

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          Abstract

          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 multi-institution 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.

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          Author and article information

          Journal
          Controlled Clinical Trials
          Controlled Clinical Trials
          Elsevier BV
          01972456
          March 1989
          March 1989
          : 10
          : 1
          : 1-10
          Article
          10.1016/0197-2456(89)90015-9
          2702835
          890310ff-9354-49b8-9a70-0f678361688e
          © 1989

          https://www.elsevier.com/tdm/userlicense/1.0/

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