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A two‐stage phase II trial design utilizing both primary and secondary endpoints
Author(s) -
Lin Xun,
Allred Randy,
Andrews Glen
Publication year - 2007
Publication title -
pharmaceutical statistics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.421
H-Index - 38
eISSN - 1539-1612
pISSN - 1539-1604
DOI - 10.1002/pst.255
Subject(s) - monte carlo method , type i and type ii errors , stage (stratigraphy) , computer science , clinical endpoint , phase (matter) , statistics , reliability engineering , mathematics , clinical trial , medicine , engineering , paleontology , chemistry , organic chemistry , biology
Phase II trials in oncology drug development are usually conducted to perform the initial assessment of treatment activity. The common designs in this setting, for example, Simon 2‐stage designs, are often developed based on testing whether a parameter of interest, usually a proportion (e.g. response rate), is less than a certain level or not. These designs usually consider only one parameter. However, sometimes we may encounter situations where we need to consider not a single parameter, but multiple parameters. This paper presents a two‐stage design in which both primary and secondary endpoints are utilized in the decision rules. The family‐wise Type 1 error rate and statistical power of the proposed design are investigated under a variety of situations by means of Monte‐Carlo simulations. Copyright © 2007 John Wiley & Sons, Ltd.