How to Deal with Sample Size Exploration and its reporting in Clinical Research?

Abstract

The minimum sample size required to answer a specific research question is unavoidable regardlessof study designs, more pertinent in case of randomized controlled trials. Sample size exploration isnot required in many situations, including a pilot study; it is simply decided as feasible or a rule ofthumb. However, in situations, including a conclusive study like the third and final phase of drugdevelopment, it becomes mandatory to ensure optimal power as well as level of confidence to thestudy. The present write-up aims to address various issues related to sample size considerations forclinical studies in a non-statistical language, focusing on making it easily understandable by medicalresearchers.