An Optimization Power Calculation Approach for Precision Medicine Clinical Trials |Biomedgrid

In clinical trials, the conventional power calculation approach for determining the required sample size cannot control the inter-subject variability. Consequently, it may underestimate the treatment effect and/or overestimate the population variance for a specific subpopulation such as the enriched population in precision medicine clinical trials. In this article, we propose an optimization power calculation approach for computing the required sample size for precision medicine clinical trials by controlling variability and maintaining the desired treatment at the same time. The proposed power calculation approach cannot only provide a smaller and more precise sample size for achieving the primary objective of the intended trial but also have a sketched idea regarding how many subjects will be accrued for achieving the secondary objectives.