Sample Size Determination in Clinical Trials: Key Concepts, Methods, and Best Practices
Sample size determination involves estimating the minimum number of participants needed to reliably detect a pre-specified treatment effect with an acceptable probability (power) while controlling the risk of Type I error. It balances the need for statistical rigor with ethical and operational considerations, ensuring that trials are neither underpowered (risking inconclusive results) nor overpowered (wasting resources and exposing too many subjects).
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