Solnyx Pharmaceuticals: The Atoxeril Clinical Trial

The head of clinical trials at Solnyx Pharmaceuticals had just been handed the results of a phase II trial of Atoxeril, a hypertension drug. Her task was to interpret these data in preparation for a meeting with her institutional review board and representatives of the Food and Drug Administration. This case introduces a number of concepts related to the analysis of clinical trials including dealing with missing data, ANOVA, regression and sample size calculations. Students will evaluate the design of the phase II clinical trial and interpret the trial results; they will also evaluate the implications of the angioedema incidence and how it might affect the design of a phase III trial.