Planning for an adaptive design: a case study in COPD.
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.
Jones
B
B
Pfizer Global Research and Development, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK. Byron.Jones@pfizer.com
Atkinson
G
G
Ward
J
J
Tan
E
E
Kerbusch
T
T
D017322:Clinical Trials, Phase II as Topic / Q000379:methods*; D003627:Data Interpretation, Statistical; D006801:Humans; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D012107:Research Design; D018401:Sample Size