The Sample Size Estimation and its SAS Code for Binary Response Endpoints Clinical Study- a Review

The aim of this article is to provide basic idea about sample size estimation in clinical study of binary response endpoints. Every clinical trial must be planned and it describes the objective, primary and secondary endpoint, method of collecting data, inclusion & exclusion criteria, sample size with scientific justification, statistical methodology. The calculation of sample size with sufficient levels of significance and power is an essential part of protocol which needs to be submitted to drug authorities for approval. In this review emphasis has been made to describe the different kind of design i.e. equivalence, non-inferiority, superiority and equality and their SAS codes for sample size calculation in clinical study.