Estimation of historical control rate for a single arm de-escalation study – Application to the POSITIVE trial

Background: Although randomized controlled clinical trials are optimal to evaluate the effect of an experimental therapy, single-arm trials are required whenever randomization is unethical or not feasible, such as de-escalation studies. We propose using prospectively identified historical controls t...

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Bibliographic Details
Main Authors: Zhuoxin Sun, Samuel M. Niman, Olivia Pagani, Ann H. Partridge, Hatem A. Azim, Jr., Fedro A. Peccatori, Monica Ruggeri, Angelo Di Leo, Marco Colleoni, Richard D. Gelber, Meredith M. Regan
Format: Article
Language:English
Published: Elsevier 2020-10-01
Series:Breast
Online Access:http://www.sciencedirect.com/science/article/pii/S0960977620301193