Evaluation of multicentre clinical trial data using adaptations of the Mosteller-Tukey procedure.
Two procedures, based on proposals discussed by Mosteller and Tukey, are described for obtaining a combined estimate of the difference between two treatment means and its confidence interval from multicentre clinical trial data. Both procedures provide estimates in the possible presence of heteroscedasticity. The first procedure is designated the primary analysis for efficacy assessment. It omits treatment-by-centre interaction from the error term for treatment, unless there is substantial evidence of qualitative interaction (Ciminera et al.) or other special circumstances. The second procedure is the primary analysis whenever there is substantial evidence of qualitative interaction, and can be used whenever there are other reasons to make an analysis allowing for interaction.
Ciminera
J L
JL
Merck Research Laboratories, West Point, PA 19486.
Heyse
J F
JF
Nguyen
H H
HH
Tukey
J W
JW
D001249:Asthma / Q000188:drug therapy / Q000453:epidemiology / Q000503:physiopathology; D001794:Blood Pressure / Q000187:drug effects; D002986:Clinical Trials as Topic / Q000379:methods*; D016001:Confidence Intervals; D003627:Data Interpretation, Statistical; D006801:Humans; D015337:Multicenter Studies as Topic / Q000379:methods*; D016011:Normal Distribution