Exposure analysis of dichotomous response measures in long-term studies.
Differential exposure to study medications in long-term studies of some cardiovascular compounds complicates analyses, particularly the usual intention-to-treat analyses and inferences therefrom of the data collected. Analysis methods that incorporate exposure are developed, presented, and illustrated by applying them to primary response data from a long-term, placebo-controlled, ancillary trial of gemfibrozil. The analysis methods address the extent to which end-points are correlated with the actual use of the compound rather than the extent to which end-points are correlated with the random assignment to double-blind study medications.
Peace
K E
KE
Biopharmaceutical Research Consultants, Inc., Ann Arbor, Michigan 48105.
Carter
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WH
D000704:Analysis of Variance; D003327:Coronary Disease / Q000188:drug therapy; D003627:Data Interpretation, Statistical; D004311:Double-Blind Method; D015248:Gemfibrozil / Q000627:therapeutic use; D006801:Humans; D016016:Proportional Hazards Models; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000706:statistics & numerical data*
D015248:Gemfibrozil