Dragalin V. Adaptive designs: terminology and classification. Drug Inf J. 2006;40:425–435.
Maca J, Bhattacharya S, Dragalin V, Gallo P, Krams M. Adaptive seamless phase II/III de-signs—background, operational aspects, and examples. Drug Inf J. 2006;40:463–473.
Quinlan JA, Krams M. Implementing adaptive designs: logistical and operational considerations. Drug Inf J. 2006;40:437–444.
Gallo P. Confidentiality and trial integrity issues for adaptive designs. Drug Inf J. 2006;40:445–450.
International Conference on Harmonisation Expert Working Group. Guideline for industry: dose response information to support drug registration. Federal Register 59(216):55,972-55,976 (1994).
Ting N, ed. Dose Finding in Drug Development. New York: Springer; 2006.
Ruberg SL. Dose response studies. I. Some design considerations. J Biopharm Stat. 1995;5:1–14.
Ruberg SL. Dose response studies. II. Analysis and interpretation. J Biopharm Stat. 1995;5:15–42.
Whitehead J, Zhou Y, Patterson S, Webber D, Francis S. Easy-to-implement Bayesian methods for dose-escalation studies in healthy volunteers. Biostatistics. 2001;2:47–61.
Rosenberger WF, Haines LM. Competing designs for phase I clinical trials: a review. Stat Med. 2002;21:2757–2770.
Reiner E, Paoletti X, O’Quigley J. Operating characteristics of the standard phase I clinical trial design. Comp Stat Data Anal. 1999;30:303–315.
Durham SD, Flournoy N. Random walks for quantile estimation. In Gupta SS, Berger JO, ed. Statistical Decision Theory and Related Topics. New York: Springer; 1994;467–476.
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.
Fades D. Practical modifications of the continual reassessment method for phase I cancer clinical trials. J Biopharm Stat. 1994;4:147–164.
Korn EL, Midthune D, Chen TT, Rubinstein LV, Christian MC, Simon RM. A comparison of two phase I designs. Stat Med. 1994;13:1799–1806.
Goodman SN, Zahurak ML, Piantadosi S. Some practical improvements in the continual reassessment method for phase I studies. Stat Med. 1995;14:1149–1161.
Dougherty TB, Porche VH, Thall PF. Maximum tolerated dose of Nalmefene in patients receiving epidural fentanyl and dilute bupivacaine for postoperative analgesia. Anesthesiology. 2000;92:1010–1016.
Babb J, Rogatko A, Zacks S. Cancer phase I clinical trials: efficient dose escalation with overdose control. Stat Med. 1998;17:1103–1120.
Whitehead J, Brunier H. Bayesian decision procedures for dose determining experiments. Stat Med. 1995;14:885–893.
Patterson S, Jones B. Bioequivalence and Statistics in Clinical Pharmacology. London: Chapman and Hall; 2005.
Whitehead J, Zhou Y, Stevens J, Blakey G. An evaluation of a Bayesian method of dose escalation based on bivariate binary responses. J Biopharm Stat. 2004;14:969–983.
Braun T. The bivariate continual reassessment method: extending the CRM to phase I trials of two competing outcomes. Controlled Clin Trials. 2002;23:240–256.
Haines LM, Perevozskaya I, Rosenberger WF. Bayesian optimal designs for phase I clinical trials. Biometrics. 2003;59:561–600.
Dragalin V, Fedorov V. Adaptive designs for dose-finding based on efficacy-toxicity response. J Stat Plann Inference. 2005;136:1800–1823.
Hochberg Y, Tamhane AC. Multiple Comparison Procedures. New York: Wiley; 1987.
Hsu JC. Multiple Comparisons. London: Chapman and Hall; 1996.
Lan KKG, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika. 1983;70:659–663.
Pocock SJ. Group sequential methods in the design and analysis of clinical trials. Biometrika. 1977;64:191–199.
O’Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979;35:549–556.
Whitehead J. The Design and Analysis of Sequential Clinical Trials. Rev. 2nd ed. Chichester, UK: Wiley; 1997.
Jennison C, Turnbull BW. Group Sequential Methods With Applications to Clinical Trials. London: Chapman and Hall; 2000.
Stallard N, Todd S. Sequential designs for phase III clinical trials incorporating treatment selection. Stat Med. 2003;22:689–703.
Jennison C, Turnbull BW. Meta-analyses and adaptive group sequential designs in the clinical development process. J Biopharm Stat. 2005;15:537–558.
Bauer P, Brannath W. The advantages and disadvantages of adaptive designs for clinical trials. DrugDiscov Today. 2004;9:351–357.
Tsiatis AA, Mehta C. On the inefficiency of the adaptive design for monitoring clinical trials. Biometrika. 2003;90:367–378.
Brannath W, Bauer P, Posch M. On the efficiency of adaptive designs for flexible interim decisions in clinical trials. J Stat Plann Inference. 2006;136:1956–1961.
Bauer P, Kohne K. Evaluation of experiments with adaptive interim analyses. Biometrics. 1994;50:1029–1041.
Lehmacher W, Wassmer G. Adaptive sample size calculations in group sequential trials. Biometrics. 1999;55:1286–1290.
Hommel G. Adaptive modifications of hypotheses after an interim analysis. Biom J. 2001;43:581–589.
Marcus R, Peritz E, Gabriel KB. On closed testing procedures with special reference to ordered analysis of variance. Biometrika. 1976;63:655–660.
Dunnett CW. A multiple comparison procedure for comparing several treatments with a control. J Am Stat Assoc. 1955;50:1096–1121.
Bretz F, Schmidli H, Konig F, Racine A, Maurer W. Confirmatory seamless phase II/III clinical trials with hypothesis selection at interim: general concepts (with discussion). Biom J. 2006;48:623–634.
Liu Q, Pledger WG. Phase II and III combination designs to accelerate drug development. J Am Stat Assoc. 2005;100:493–502.
Todd S, Stallard N. A new clinical trial design combining phases II and III: sequential designs with treatment selection and a change of end-point. Druglnf J. 2005;39:109–118.
Spiegelhalter DJ, Abrams KR, Myles JP. Bayesian Approaches to Clinical Trials and Health-Care Evaluation. Chichester, UK: Wiley; 2004.
Berry DA. Statistical innovations in cancer research. In Holland J, Frei T, et al. eds. Cancer Medicine e.7. London: Decker; 2005:411–425.
Berry DA. Bayesian clinical trials. Nat Rev Drug Discov. 2006;5:27–36.
Berry DA. Statistics: A Bayesian Perspective. Belmont, CA: Duxbury Press; 1996.
Berry DA, Miiller P, Grieve AP, et al. Adaptive Bayesian designs for dose-ranging drug trials. In Gatsonis C, Carlin B, Carriquiry A, eds. Case Studies in Bayesian Statistics V. New York: Springer-Verlag; 2001:99–181.
West M, Harrison J. Bayesian Forecasting and Dynamic Models. 2nd ed. New York: Springer-Verlag; 1997.
Krams M, Lees KR, Hacke W, Grieve AP, Orgogozo J-M, Ford GA. Acute stroke therapy by inhibition of neutrophils (ASTIN): an adaptive dose response study of UK-279,276 in acute ischemic stroke. Stroke. 2003;34:2543–2548.
US Food and Drug Administration. Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees. Rockville, MD: US Food and Drug Administration; August 22, 2006. Available at: http://www.fda.gov.
Smith MK, Jones I, Morris MF, Grieve AP, Tan K. Implementation of a Bayesian adaptive design in proof of concept study. Pharm Stat. 2006;5:39–50.
Roon KI, Olesen J, Diener HC, et al. No acute antimigraine efficacy of CP-122,288, a highly potent inhibitor of neurogenic inflammation: results of two randomized, double-blind, placebo controlled clinical trials. Ann Neurol. 2000;47:238–241.
Farge D, Marolleau JP, Zohar S, et al. Autologous bone marrow transplantation in the treatment of refractory systemic sclerosis: early results from a French multicentre phase I-II study. Br J Haematol. 2002;119:726–739.
Camorcia M, Capogna G, Lyons G, Columb M. Epidural test dose with levobupivacaine and ropivacaine: determination of ED50 motor block after spinal administration. Br J Anaesth. 2004;92:850–853.
Desfrere L, Zohar S, Morville P, et al. Dose-finding study of ibuprofen in patent ductus arteriosus using the continual reassessment method. J Clin PharmTher. 2005;30:121–132.