Semiparametric Weighted Spline Regression (SWSR) in Confirmatory Clinical Trials with Time-Varying Placebo Effects
时变安慰剂效应确证性临床试验中的半参数加权样条回归
In confirmatory Phase 3 clinical trials with recruitment over the years, the underlying placebo effect may follow an unknown temporal trend. Taking a clinical trial on Hidradenitis Suppurativa (HS) as an example, fluctuations or variabilities are common in HS-related endpoints, mainly due to the natural disease characteristics, variations of evaluation from different physicians, and standard of care evolvement. The adjustment of time-varying placebo effects receives some…