Sample Size in the Planning and Interpretation of Clinical Trials

An understanding of sample size determination is important in both planning and interpreting the results of clinical trials. A Type II error occurs when it is concluded that there is no difference between treatment groups, when in truth there is a difference. Such a false negative conclusion results from too few patients in a trial. In this review the principles of estimating sample size before a trial is commenced and evaluating the results of a negative completed trial are reviewed. Clinically relevant examples are used to illustrate these concepts.