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Accueil Tous les numéros Volume 66 / Numéro 4 (Juillet-Août 2011) Therapie, 66 4 (2011) 309-317 Références
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Numéro
Therapie
Volume 66, Numéro 4, Juillet-Août 2011
Page(s) 309 - 317
Section Méthodologie / Methodology
DOI https://doi.org/10.2515/therapie/2011042
Publié en ligne 19 août 2011
  1. Bretz F, Schmidli H, König F, et al. Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim : general concepts. Biom J 2006; 48 : 623-34 [CrossRef] [PubMed] [Google Scholar]
  2. Gallo P, Chuang-Stein C, Dragalin V, et al. Adaptive designs in clinical drug development. An executive summary of the PhRMA Working Group. J Biopharm Stat 2006; 16 : 275-83 [CrossRef] [PubMed] [Google Scholar]
  3. Bretz F, Koenig F, Brannath W, et al. Adaptive designs for confirmatory clinical trials. Stat Med 2009; 28 : 1181-217 [CrossRef] [PubMed] [Google Scholar]
  4. Bretz F,Branson M,Burman CF, et al. Adaptivity in drug discovery and development. Drug Development Research 2009; 70 :169-90 [CrossRef] [Google Scholar]
  5. Schmidli H, Bretz F, Racine A, et al. Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim : applications and practical considerations. Biom J 2006; 48 : 635-43 [CrossRef] [PubMed] [Google Scholar]
  6. FDA. Critical Path Opportunities List. 2006 http://www.fda.gov/oc/initiatives/criticalpath/ [Google Scholar]
  7. CHMP. Reflection paper on methodological issues in confirmatory clinical trials planned with an adaptive design. 2009 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003616.pdf [Google Scholar]
  8. FDA. Guidance for Industry : adaptive design clinical trials for drugs and biologics. 2010 http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm201790.pdf [Google Scholar]
  9. Dragalin V. Adaptive designs : terminology and classification. Drug Info J 2006; 40 : 425-35 [Google Scholar]
  10. Brannath W, Koenig F, Bauer P. Multiplicity and flexibility in clinical trials. Pharm Stat 2007; 6 : 205-16 [CrossRef] [PubMed] [Google Scholar]
  11. CPMP. ICH E9 : note for guidance on statistical priniples for clinical trials [Internet]. 1998 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002928.pdf [Google Scholar]
  12. Bauer P, Brannath W, Posch M. Flexible two-stage designs : an overview. Meth Info Med 2001; 40 : 117-21 [Google Scholar]
  13. Bauer P, Köhne K. Evaluation of experiments with adaptive interim analyses. Biometrics 1994; 50 : 1029-41 [CrossRef] [PubMed] [Google Scholar]
  14. Brannath W, Posch M, Bauer P. Recursive combination tests. J Am Statist Assoc 2002; 97(457) : 236-44 [CrossRef] [Google Scholar]
  15. Proschan MA, Hunsberger SA. Designed extension of studies based on conditional power. Biometrics 1995; 51 : 1315-24 [CrossRef] [PubMed] [Google Scholar]
  16. Posch M, Bauer P. Adaptive two stage designs and the conditional error function. Biom J 1999; 41 : 689-96 [CrossRef] [Google Scholar]
  17. Marcus R, Eric P, Gabriel KR. On closed testing procedures with special reference to ordered analysis of variance. Biometrika 1976; 63 : 655-60 [CrossRef] [Google Scholar]
  18. Spiegelhalter DJ, Abrams KR, Myles JP. Bayesian approaches to clinical trials and health-care evaluation. Chichester : Wiley, 2004 [Google Scholar]
  19. O’Quigley J, Pepe M, Fisher L. Continual reassessment method : a practical design for phase 1 clinical trials in cancer. Biometrics 1990; 46 : 33-48 [CrossRef] [PubMed] [Google Scholar]
  20. Berry DA, Mueller P, Grieve AP, et al. Adaptive Bayesian designs for dose-ranging drug trials. Case Studies in Bayesian Statistics 2001; 5 : 99–181 [Google Scholar]
  21. Schmidli H,Bretz F, Racine Poon A. Bayesian predictive power for interim adaptation in seamless phase II/III trials where the endpoint is survival up to some specified timepoint. Stat Med 2007; 26 : 4925-38 [CrossRef] [PubMed] [Google Scholar]
  22. Berry SM, Carlin BP, Lee JJ, et al. Bayesian adaptive methods for clinical trials. Boca Raton : CRC Press, 2010 [Google Scholar]
  23. Garrett-Mayer E. The continual reassessment method for dose-finding studies : a tutorial. Clin Trials 2006; 3 : 57-71 [CrossRef] [PubMed] [Google Scholar]
  24. O’Quigley J, Zohar S. Experimental designs for phase I and phase I/II dose-finding studies. Br J Cancer 2006; 94 : 609-13 [PubMed] [Google Scholar]
  25. Levy V, Zohar S, Bardin C, et al. A phase I dose-finding and pharmacokinetic study of subcutaneous semisynthetic homoharringtonine (ssHHT) in patients with advanced acute myeloid leukaemia. Br J Cancer 2006; 95 : 253-9 [CrossRef] [PubMed] [Google Scholar]
  26. Huang X, Biswas S, Oki Y, et al. A parallel phase I/II clinical trial design for combination therapies. Biometrics 2007; 63 : 429-36 [CrossRef] [PubMed] [Google Scholar]
  27. Posch M, Koenig F, Branson M, et al. Testing and estimation in flexible group sequential designs with adaptive treatment selection. Stat Med 2005; 24 : 3697-714 [CrossRef] [PubMed] [Google Scholar]
  28. Liu Q, Pledger GW. Phase 2 and 3 combination designs to accelerate drug development. J Am Statist Assoc 2005; 100(470) : 493-502 [CrossRef] [Google Scholar]
  29. Donohue JF, Fogarty C, Lotvall J, et al. Once-daily bronchodilators for chronic obstructive pulmonary disease : indacaterol versus tiotropium. Am J Resp Crit Care Med 2010; 182 : 155-62 [CrossRef] [Google Scholar]
  30. Chuang-Stein C, Anderson K, Gallo P, et al. Sample size re-estimation : a review and recommendations. Drug Info J 2006; 40 : 475-84 [Google Scholar]
  31. Tsiatis AA, Mehta C. On the inefficiency of the adaptive design for monitoring clinical trials. Biometrika 2003; 90 : 367-78 [CrossRef] [Google Scholar]
  32. Burman CF, Sonesson C. Are flexible designs sound? Biometrics 2006; 62 : 664-9 [CrossRef] [PubMed] [Google Scholar]
  33. Bauer P, Koenig F. The reassessment of trial perspectives from interim data-a critical view. Stat Med 2006; 25 : 23-36 [CrossRef] [PubMed] [Google Scholar]
  34. Desseaux K, Porcher R. Flexible two-stage design with sample size reassessment for survival trials. Stat Med 2007; 26 : 5002-13 [CrossRef] [PubMed] [Google Scholar]
  35. Wang SJ, O’Neill RT, Hung HM. Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset. Pharm Stat 2007; 6 : 227-44 [CrossRef] [PubMed] [Google Scholar]
  36. Brannath W, Zuber E, Branson M, et al. Confirmatory adaptive designs with Bayesian decision tools for a targeted therapy in oncology. Stat Med 2009; 28 : 1445-63 [CrossRef] [PubMed] [Google Scholar]