Adaptive Enrichment Designs with Sample Size Re-Estimation
Software of 'esDesign' is developed to implement the adaptive
enrichment designs with sample size re-estimation presented in
Lin et al. (2021) . In details,
three-proposed trial designs are provided, including the AED1-SSR (or ES1-SSR),
AED2-SSR (or ES2-SSR) and AED3-SSR (or ES3-SSR). In addition, this package
also contains several widely used adaptive designs, such as the Marker
Sequential Test (MaST) design proposed Freidlin et al.
(2014) <10.1177>, the adaptive enrichment designs
without early stopping (AED or ES), the sample size re-estimation
procedure (SSR) based on the conditional power proposed by
Proschan and Hunsberger (1995), and some useful functions.
In details, we can calculate the futility and/or efficacy stopping
boundaries, the sample size required, calibrate the value of the threshold
of the difference between subgroup-specific test statistics, conduct the
simulation studies in AED, SSR, AED1-SSR, AED2-SSR and AED3-SSR.10.1177>