A Simulation Study to Compare New Adaptive Dose-Ranging Designs

作者：Dragalin Vladimir^*; Bornkamp Bjoern; Bretz Frank; Miller Frank; Padmanabhan S Krishna; Patel Nitin; Perevozskaya Inna; Pinheiro Jose; Smith Jonathan R

来源：Statistics in Biopharmaceutical Research, 2010, 2(4): 487-512.

DOI：10.1198/sbr.2010.09045

• Adaptive allocation
• Adaptive clinical trial
• Dose-finding
• Dose-ranging
• Dose-response
• Minimum effective dose
• Phase II
• Response-adaptive allocation
• Target dose

The main goals in an adaptive dose-ranging study are to detect dose response, to determine if any doses(s) meets clinical relevance, to estimate the dose-response, and then to decide on the dose(s) (if any) to take into the confirmatory Phase III. Adaptive dose-ranging study designs may result in power gains to detect dose response and higher precision in estimating the target dose and the dose response curve. In this article, we complement the library of available methods with five new adaptive dose-ranging designs. Due to their inherent complexity, the operating characteristics can be assessed only through intensive simulations. We present here results of a comprehensive simulation study that compares and contrasts these designs for a variety of different scenarios.

• 出版日期2010-11