Hypothesis and Hypothesis Testing in the Clinical Trial

The hypothesis provides the justification for the clinical trial. It is antecedent to the trial and establishes the trial’s direction. Hypothesis testing is the most widely employed method of determining whether the outcome of clinical trials is positive or negative. Too often, however, neither the hypothesis nor the statistical information necessary to evaluate outcomes, such as p values and α levels, is stated explicitly in reports of clinical trials. This article examines 5 recent studies comparing atypical antipsychotics with special attention to how they approach the hypothesis and hypothesis testing. Alternative approaches are also discussed.