Re-formulating Gehan’s design as a flexible two-stage single-arm trial
Author:
Funder
Medical Research Council
Publisher
Springer Science and Business Media LLC
Subject
Health Informatics,Epidemiology
Link
http://link.springer.com/content/pdf/10.1186/s12874-019-0659-2.pdf
Reference21 articles.
1. Gehan E. The determination of the number of patients required in a preliminary and a follow-up trial of a new chemotherapeutic agent. J Chronic Dis. 1961; 13(4):346–53.
2. Rubinstein L. Phase II design: History and evolution. Chin Clin Oncol. 2014; 3(4):48.
3. Simon R. Optimal Two-Stage Designs for Phase II Clinical Trials. Control Clin Trials. 1989; 10(1):1–10.
4. Grayling MJ, Mander AP. Do single-arm trials have a role in drug development plans incorporating randomised trials?Pharm Stat. 2016; 15(2):143–51.
5. Ivanova A, Paul B, Marchenko O, Song G, Patel N, Moschos S. Nine-year change in statistical design, profile, and success rates of phase II oncology trials. J Biopharm Stat. 2016; 26(1):141–9.
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