Accès gratuit
Numéro
Therapie
Volume 66, Numéro 4, Juillet-Août 2011
Page(s) 327 - 330
Section Affaires réglementaires / Regulatory system
DOI https://doi.org/10.2515/therapie/2011043
Publié en ligne 19 août 2011
  1. 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]
  2. 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]
  3. 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]
  4. 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 Comments on the draft guidance on "adaptive design clinical trials for drugs and biologics" of the U.S. Food and Drug Administration.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]
  5. 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]
  6. 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 On flexibility of adaptive designs and criteria for choosing a good one–a discussion of FDA draft guidance.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]
  7. Chow SC. A note on special articles on adaptive clinical trial designs. J Biopharm Stat 2010Nov; 20(6) : 1088-9 [CrossRef] [PubMed] [Google Scholar]
  8. Chuang-Stein C, Beltangady M. FDA draft guidance on adaptive design clinical trials : Pfizer’s perspective.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]
  9. Cook T, DeMets DL. Review of draft FDA adaptive design guidance. J Biopharm Stat 2010Nov; 20(6) : 1132-42 [CrossRef] [PubMed] [Google Scholar]
  10. Emerson SS, Fleming TR. Adaptive methods : telling “the rest of the story”. J Biopharm Stat 2010Nov; 20(6) : 1150-65 [CrossRef] [PubMed] [Google Scholar]
  11. Fu H, Manner D. Bayesian adaptive dose-finding studies with delayed responses. J Biopharm Stat 2010Sep; 20(5) : 1055-70 [CrossRef] [PubMed] [Google Scholar]
  12. 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]
  13. 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]
  14. 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]
  15. 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]
  16. 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]
  17. Zhou Y. Adaptive designs for Phase I dose-finding studies. Fundam Clin Pharmacol 2010Apr; 24(2) : 129-38 [PubMed] [Google Scholar]