Sample size reestimation for confirmatory clinical trials

Designs for Clinical Trials: Perspectives on Current Issues

Volumn , Issue , 2012, Pages 81-108

  Mehta, Cyrus R ^a  

^a HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84884702679     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1007/978-1-4614-0140-7_4     Document Type: Chapter

References (25)

1. Bauer P, Koenig F (2006) The reassessment of trial perspectives from interim data - a critical view. Stat Med 25(1):23-36
2. Bauer P, Kohne K (1994) Evaluation of experiments with adaptive interim analyses. Biometrics 50(4):1029-1041
3. Brannath W, Mehta CR, Posch M (2009) Exact confidence bounds following adaptive group sequential tests. Biometrics 65(2):539-546
4. Chen YH, DeMets DL, Lan KK (2004) Increasing the sample size when the unblinded interim result is promising. Stat Med 23(7):1023-1038
5. Cui L, Hung HM, Wang SJ (1999) Modification of sample size in group sequential clinical trials. Biometrics 55(3):853-857
6. East (2008) Software for design and monitoring of group sequential and adaptive trials; version 5.3. Cytel Inc., MA. www.cytel.com
7. FDA (2004) Innovation or stagnation: Challenge and opportunity on the critical path to new medical products. http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html
8. FDA (2010) Guidance for industry: Adaptive design clinical trials for drugs and biologics. http:// www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM201790.pdf
9. Gao P, Ware JH, Mehta C (2008) Sample size re-estimation for adaptive sequential design in clinical trials. J Biopharm Stat 18(6):1184-1196
10. Haybittle JL (1971) Repeated assessment of results in clinical trials of cancer treatment. Br J Radiol 44(526):793-797
11. Hedges LV, Olkin I (1985) Statistical methods for meta-analysis. Academic, New York
12. Hwang IK, Shih WJ, DeCani JS (1990) Group sequential designs using a family of type i error probability spending functions. Stat Med 9:1439-1445
13. Jennison C, Turnbull BW (2003) Mid-course sample size modification in clinical trials based on the observed treatment effect. Stat Med 22(6):971-993
14. Lan KKG, Demets DL (1983) Discrete sequential boundaries for clinical trials. Biometrika 70(3):659-663
15. Lehmacher W, Wassmer G (1999) Adaptive sample size calculations in group sequential trials. Biometrics 55(4):1286-1290
16. Mehta C, Gao P, Bhatt DL, Harrington RA, Skerjanec S, Ware JH (2009) Optimizing trial design: Sequential, adaptive, and enrichment strategies. Circulation 119(4):597-605
17. Mehta CR, Pocock SJ (2010) Adaptive increase in sample size when interim results are promising: A practical guide with examples. Stat Med, Wiley Online Library, November 2010
18. Mehta CR, Bauer P, Posch M, BrannathW(2007) Repeated confidence intervals for adaptive group sequential trials. Stat Med 26(30):5422-5433
19. Muller HH, Schafer H (2001) Adaptive group sequential designs for clinical trials: Combining the advantages of adaptive and of classical group sequential approaches. Biometrics 57(3):886-891
20. PhRMA (2007) White paper of the phrma adaptive working group. DIA J
21. Pocock SJ (2005) When (not) to stop a clinical trial for benefit. JAMA 294:2228-2230
22. Proschan MA, Hunsberger SA (1995) Designed extension of studies based on conditional power. Biometrics 51(4):1315-1324
23. Tsiatis A, Mehta C (2003) On the inefficiency of the adaptive design for monitoring clinical trials. Biometrika 90(2):367-378
24. Wassmer G (2006) Planning and analyzing adaptive group sequential survival trials. Biom J 48(4):714-729
25. Woodcock J, Woosley R (2008) The fda critical path initiative and its influence on new drug development. Annu Rev Med 59:1-12