Angina clinical trial methodology.

Abstract

This paper reviews the general structure of clinical trials with special reference to those in the area of angina. In particular, aspects of experimental design in exercise testing, ambulatory monitoring and mortality studies are examined critically. Parallel group and crossover studies are compared and contrasted. Sensitivity analysis of the power of any proposed trial is recommended, and problems that can arise in the area of event rate estimation are illustrated. Additional problems associated with trials involving combination therapies, trials with no placebo group and regression to the mean are discussed.