An introduction to adaptive designs and adaptation in CNS trials

European Neuropsychopharmacology

Volumn 21, Issue 2, 2011, Pages 153-158

  Dragalin, Vladimir ^a  

^a NONE   (United States)

Author keywords

Adaptive design; Biomarker; Central Nervous System; Dose ranging study; Seamless design

Indexed keywords

ADAPTIVE DESIGN; CENTRAL NERVOUS SYSTEM; CLINICAL TRIAL (TOPIC); DATA ANALYSIS; DECISION MAKING; DOSE CALCULATION; EXPLORATORY RESEARCH; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PLANNING; PRIORITY JOURNAL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SAMPLING; SIMULATION; STUDY DESIGN;

CENTRAL NERVOUS SYSTEM AGENTS; CENTRAL NERVOUS SYSTEM DISEASES; CLINICAL TRIALS AS TOPIC; DRUG DESIGN; HUMANS; RESEARCH DESIGN; TIME FACTORS;

EID: 78751614807     PISSN: 0924977X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.euroneuro.2010.09.004     Document Type: Review

References (26)

1. Berry D.A. Bayesian clinical trials. Nat. Rev. Drug Discov. 2006, 5:27-36.
2. Biswas S., et al. Bayesian clinical trials at the University of Texas M. D. Anderson Cancer Center. Clin. Trials 2009, 6:205-216.
3. Bornkamp B., et al. Innovative approaches for designing and analyzing adaptive dose-ranging trials (with discussion). J. Biopharm. Stat. 2007, 17:965-995.
4. Bretz F., et al. Tutorial in biostatistics: adaptive designs for confirmatory clinical trials. Stat. Med. 2009, 28:1181-1217.
5. CHMP Reflection paper on methodological issues in confirmatory clinical trials planned with an adaptive design Available at. http://www.emea.europa.eu/pdfs/human/ewp/245902enadopted.pdf.
6. Chuang-Stein C., et al. Sample size reestimation: a review and recommendations. Drug Inf. J. 2006, 40:475-484.
7. Dragalin V. Adaptive designs: terminology and classification. Drug Inf. J. 2006, 40:425-435.
8. Dragalin V. Designing, monitoring, and modifying an adaptive trial. Am. Pharm. Outsourcing 2008, 9:12-16.
9. Fardipour, et al. Planning and executing response-adaptive learn-phase clinical trials: 1. the process. Drug Inf. J. 2009, 43:713-723.
10. Fardipour, et al. Planning and executing response-adaptive learn-phase clinical trials: 2. case studies. Drug Inf. J. 2009, 43:725-734.
11. FDA Critical Path Opportunity List Available at. http://www.fda.gov/oc/initiatives/criticalpath/.
12. FDA Guidance for Industry. Adaptive Design Clinical Trials for Drugs and Biologics Available at. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf.
13. Fleming T.R., DeMets D.L. Surrogate end points in clinical trials: are we being misled?. Ann. Int. Med. 1996, 125:605-613.
14. Gallo P., et al. Executive summary of the PhrMA working group on adaptive designs in clinical drug development. J. Biopharm. Stat. 2006, 16:275-283.
15. Gaydos B., et al. Adaptive dose-response studies. Drug Inf. J. 2006, 40:451-461.
16. Gaydos B., et al. Good practices for adaptive clinical trials in pharmaceutical product development. Drug Inf. J. 2009, 43:539-556.
17. Gottlieb S. Speech before 2006 Conference on Adaptive Trial Design, Washington, DC http://www.fda.gov/oc/speeches/2006/trialdesign0710.html.
18. Gould L. Sample-size re-estimation: recent developments and practical considerations. Stat. Med. 2001, 20:2625-2643.
19. Jennison C., Turnbull B.W. Group Sequential Methods with Applications to Clinical Trials 2000, Chapman & Hall, Boca Raton.
20. Krams M., et al. Adaptive designs in clinical drug development: opportunities, challenges, and scope reflections following PhRMA's November 2006 workshop. J. Biopharm. Stat. 2007, 17:957-964.
21. Maca J., et al. Adaptive seamless Phase II/II designs - background, operational aspects, and examples. Drug Inf. J. 2006, 40:463-473.
22. Posch M., Bauer P. Adaptive two stage designs and the conditional error function. Biometrical J. 1999, 41:689-696.
23. Posch M., et al. Issues in designing flexible trials. Stat. Med. 2003, 22:953-969.
24. Quinlan J., Krams M. Implementing adaptive designs: logistical and operational considerations. Drug Inf. J. 2006, 40:437-444.
25. Rosenberger W.F., Lachin J.M. Randomization in Clinical Trials: Theory and Practice 2002, Wiley, New York.
26. Wassmer G. Basic concepts of group sequential and adaptive group sequential procedures. Stat. Papers 2000, 41:253-279.