A primer for statistical analysis of clinical trials.

Randomized controlled trials have become the cornerstone of current practice evidence-based medicine. In this article, we present concise descriptions of fundamental statistical concepts and methods frequently used in the analysis of randomized trials. These include descriptive statistics, statistical inferences, techniques for the comparison of means or proportions from two samples, correlation, and regression analysis methods. The uses of these methods are illustrated with a number of practical examples, and the pitfalls of these topics are also briefly discussed. Lastly, some frequently used statistical terms and their meanings are also provided. By the end of the article, the reader should have sufficient knowledge to appreciate the statistical aspects of most clinical trial reports.