How to Deal with Sample Size Exploration and its reporting in Clinical Research?
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Abstract
The minimum sample size required to answer a specific research question is unavoidable regardless
of study designs, more pertinent in case of randomized controlled trials. Sample size exploration is
not required in many situations, including a pilot study; it is simply decided as feasible or a rule of
thumb. However, in situations, including a conclusive study like the third and final phase of drug
development, it becomes mandatory to ensure optimal power as well as level of confidence to the
study. The present write-up aims to address various issues related to sample size considerations for
clinical studies in a non-statistical language, focusing on making it easily understandable by medical
researchers.
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