title: Statistical inference for clinical trials with binary responses when there is a shift in patient population.
abstract: In clinical research, it is not uncommon to modify a trial procedure and/or statistical methods of ongoing clinical trials through protocol amendments. A major modification to the study protocol could result in a shift in target patient population. In addition, frequent and significant modifications could lead to a totally different study that is unable to address the medical questions that the original study intended to answer. In this article, we propose a logistic regression model for statistical inference based on a binary study endpoint for trials with protocol amendments. Under the proposed method, sample size adjustment is also derived.
authors: Department of Statistics, National Cheng Kung University, Tainan, Taiwan. lyyang@stat.ncku.edu.tw
authors: Lan-Yan
authors: LY
authors: Yang
authors: Yunchan
authors: Y
authors: Chi
authors: Shein-Chung
authors: SC
authors: Chow
mesh_terms: D002985:Clinical Protocols; D002986:Clinical Trials as Topic / Q000379:methods / Q000706:statistics & numerical data*; D003198:Computer Simulation; D006801:Humans; D016015:Logistic Models; D016555:Matched-Pair Analysis; D012107:Research Design / Q000706:statistics & numerical data*; D018401:Sample Size; D016896:Treatment Outcome