Accès gratuit
Numéro |
Therapie
Volume 66, Numéro 4, Juillet-Août 2011
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Page(s) | 331 - 334 | |
Section | Affaires réglementaires / Regulatory system | |
DOI | https://doi.org/10.2515/therapie/2011046 | |
Publié en ligne | 19 août 2011 |
- Jenkins M, Stone A, Jennison C. An adaptive seamless phase II/III design for oncology trials with subpopulation selection using correlated survival endpointsdagger. Pharm Stat 2010 Dec 8 [Google Scholar]
- Eickhoff JC,Kim K,Beach J, et al. A Bayesian adaptive design with biomarkers for targeted therapies. Clin Trials 2010Oct; 7(5): 546-56 [CrossRef] [PubMed] [Google Scholar]
- Benda N,Brannath W,Bretz F, et al. Perspectives on the use of adaptive designs in clinical trials. Part II. Panel discussion. J Biopharm Stat 2010Nov; 20(6): 1098-112 [CrossRef] [PubMed] [Google Scholar]
- Brannath W,Burger HU,Glimm E, et al. Comments on the draft guidance on "adaptive design clinical trials for drugs and biologics" of the U.S. Food and Drug Administration. J Biopharm Stat 2010Nov; 20(6): 1125-31 [CrossRef] [PubMed] [Google Scholar]
- Chang M. Introduction to discussion papers on draft FDA guidance on adaptive designs. J Biopharm Stat 2010Nov; 20(6): 1113-4 [CrossRef] [PubMed] [Google Scholar]
- Cheng B,Chow SC. On flexibility of adaptive designs and criteria for choosing a good one–a discussion of FDA draft guidance. J Biopharm Stat 2010Nov; 20(6): 1171-7 [CrossRef] [PubMed] [Google Scholar]
- Chow SC. A note on special articles on adaptive clinical trial designs. J Biopharm Stat 2010Nov; 20(6): 1088-9 [CrossRef] [PubMed] [Google Scholar]
- Chuang-Stein C,Beltangady M. FDA draft guidance on adaptive design clinical trials: Pfizer’s perspective. J Biopharm Stat 2010Nov; 20(6): 1143-9 [CrossRef] [PubMed] [Google Scholar]
- Cook T,DeMets DL. Review of draft FDA adaptive design guidance. J Biopharm Stat 2010Nov; 20(6): 1132-42 [CrossRef] [PubMed] [Google Scholar]
- Emerson SS,Fleming TR. Adaptive methods: telling "the rest of the story". J Biopharm Stat 2010Nov; 20(6): 1150-65 [CrossRef] [PubMed] [Google Scholar]
- Fu H,Manner D. Bayesian adaptive dose-finding studies with delayed responses. J Biopharm Stat 2010Sep; 20(5): 1055-70 [CrossRef] [PubMed] [Google Scholar]
- Gallo P,Anderson K,Chuang-Stein C, et al. Viewpoints on the FDA draft adaptive designs guidance from the PhRMA working group. J Biopharm Stat 2010Nov; 20(6): 1115-24 [CrossRef] [PubMed] [Google Scholar]
- Liu Q,Chi GY. Understanding the FDA guidance on adaptive designs: historical, legal, and statistical perspectives. J Biopharm Stat 2010Nov; 20(6): 1178-219 [CrossRef] [PubMed] [Google Scholar]
- Lu Q,Tse SK,Chow SC. Analysis of time-to-event data under a two-stage survival adaptive design in clinical trials. J Biopharm Stat 2010Jul; 20(4): 705-19 [CrossRef] [PubMed] [Google Scholar]
- Wang SJ. Editorial. Adaptive designs: appealing in development of therapeutics, and where do controversies lie? J Biopharm Stat 2010Nov; 20(6): 1083-7 [CrossRef] [PubMed] [Google Scholar]
- Wang SJ. Perspectives on the use of adaptive designs in clinical trials. Part I. Statistical considerations and issues. J Biopharm Stat 2010Nov; 20(6): 1090-7 [CrossRef] [PubMed] [Google Scholar]
- Zhou Y. Adaptive designs for Phase I dose-finding studies. Fundam Clin Pharmacol 2010Apr; 24(2): 129-38 [PubMed] [Google Scholar]