esDesign

Software of 'esDesign' is developed to implement the adaptive enrichment designs with sample size re-estimation presented in Lin et al. (2021) doi:10.1016/j.cct.2020.106216. 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) doi:10.1177/1740774513503739, 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.