The calculation of sample size is a critical component in the design phase of clinical trials incorporating health economic evaluations. A reasonable sample size is essential to ensure the scientific validity and accuracy of trial results. This paper summarizes the sample size calculation methods in the frequentist framework based on two health economic evaluation indicators: incremental cost-effectiveness ratio (ICER) and net benefit and examines these methods in terms of their applicable conditions, advantages, and limitations. The ICER method derives the sample size calculation formula by computing the ratio of incremental cost to incremental effect, while the net benefit method determines the economic viability of interventions by calculating incremental net benefit, subsequently leading to the formulation of the sample size calculation. Furthermore, this paper briefly discusses other sample size calculation methods, such as the classical Bayesian approach and the value of information analysis, providing a reference for calculating sample size in clinical trials with integrated health economic evaluations.
