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Planning for an adaptive design: a case study in COPD
Author(s) -
Jones B.,
Atkinson G.,
Ward J.,
Tan E.,
Kerbusch T.
Publication year - 2006
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.223
Subject(s) - interim , copd , pulmonary disease , adaptive design , clinical trial , interim analysis , research design , computer science , intensive care medicine , medical physics , clinical study design , medicine , risk analysis (engineering) , management science , statistics , engineering , mathematics , archaeology , history
We discuss the practical and clinical considerations encountered when planning a Phase IIa trial in chronic obstructive pulmonary disease (COPD). Various adaptive strategies for reducing the cost of the trial and the statistical implications of these are explored. Use of the EAST software to evaluate the properties of the study designs with one or more interim analyses for futility, efficacy or either is described. We emphasize the rationale for choosing between alternative designs and the relationship between the clinical and statistical considerations. Copyright © 2006 John Wiley & Sons, Ltd.