Repeated confidence intervals for adaptive group sequential trials

Statistics in Medicine

Volumn 26, Issue 30, 2007, Pages 5422-5433

  Mehta, Cyrus R ^a,b   Bauer, Peter ^c   Posch, Martin ^c   Brannath, Werner ^c  

^a Cytel Corporation   (United States)

^b HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^c MEDICAL UNIVERSITY OF VIENNA   (Austria)

Author keywords

Clinical trial; Conditional power; Estimation in flexible design; Inflation of type I error rate; Sample size re estimation

Indexed keywords

BIOMETRY; BRAIN DEPTH STIMULATION; CLINICAL TRIAL; CONFERENCE PAPER; CONFIDENCE INTERVAL; HEALTH STATISTICS; HUMAN; NULL HYPOTHESIS; PARKINSON DISEASE; PROBABILITY; QUALITY OF LIFE; QUESTIONNAIRE; SAMPLE SIZE; SEQUENTIAL ANALYSIS; STATISTICAL ANALYSIS; TREATMENT OUTCOME;

BIAS (EPIDEMIOLOGY); BIOMETRY; CLINICAL TRIALS AS TOPIC; CONFIDENCE INTERVALS; DATA INTERPRETATION, STATISTICAL; DEEP BRAIN STIMULATION; HUMANS; PARKINSON DISEASE; RESEARCH DESIGN; SAMPLE SIZE; TREATMENT OUTCOME;

EID: 38849151543     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.3062     Document Type: Conference Paper

References (26)

1. Bauer P, Köhne K. Evaluation of experiments with adaptive interim analyses. Biometrics 1994; 50:1029-1041.
2. Proschan MA, Hunsberger SA. Designed extension of studies based on conditional power. Biometrics 1995; 51:1315-1324.
3. Lehmacher W, Wassmer G. Adaptive sample size calculations in group sequential trials. Biometrics 1999; 45:1286-1290.
4. Cui L, Hung HMJ, Wang S-J. Modification of sample size in group sequential trials. Biometrics 1999; 55:853-857.
5. Denne JS. Sample size recalculation using conditional power. Statistics in Medicine 1999; 20:2645-2660.
6. Müller H-H, Schäfer H. Adaptive group sequential designs for clinical trials: combining the advantages of adaptive and of classical group sequential approaches. Biometrics 2001; 57:886-891.
7. Müller H-H, Schäfer H. A general statistical principle for changing a design any time during the course of a trial. Statistics in Medicine 2004; 23:2497-2508.
8. Cheng Y, Shen Y. Estimation of a parameter and its exact confidence interval following sequential sample size reestimation trials. Biometrics 2002; 60:910-918.
9. Shen Y, Fisher LD. Statistical inference for self-designing clinical trials with a one-sided hypothesis. Biometrics 1995; 55:190-197.
10. Lawrence J, Hung HMJ. Estimation confidence intervals after adjusting the maximum information. Biometrical Journal 2003; 45(2):143-152.
11. Brannath W, Posch M, Bauer P. Recursive combination tests. Journal of the Acoustical Society of America 2002; 97(457):236-244.
12. Jennison C, Turnbull BW. Interim analyses: the repeated confidence interval approach (with Discussion). Journal of the Royal Statistical Society, Series B 1989; 51:305-361.
13. Brannath W, König F, Bauer P. Improved repeated confidence bounds in trials with a maximal goal. Biometrical Journal 2003; 45:311-324.
14. Jennison C, Turnbull BW. Group Sequential Methods with Applications to Clinical Trials. Chapman & Hall/CRC: London, 2000.
15. Armitage P, McPherson CK, Rowe BC. Repeated significance tests on accumulating data. Journal of the Royal Statistical Society, Series A 1969; 132:232-244.
16. Lan G, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983; 70(3):659-663.
17. Schäfer M, Müller H-H. Modification of the sample size and the schedule of interim analyses in survival trials based on data inspections. Statistics in Medicine 2001; 20:3741-3751.
18. Kim K, DeMets DL. Design and analysis of group sequential tests based on the type I error spending rate function. Biometrika 1987; 74:149-154.
19. Hwang IK, Shih WJ, DeCani JS. Group sequential designs using a family of type I error probability spending functions. Statistics in Medicine 1990; 9:1439-1445.
20. Wang SK, Tsiatis AA. Approximately optimal one-parameter boundaries for group sequential trials. Biometrics 1987; 43:193-200.
21. Pampallona S, Tsiatis AA. Group sequential designs for one and two sided hypothesis testing with provision for early stopping in favour of the null hypothesis. Journal of Statistical Planning and Inference 1994; 42:19-35.
22. O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979; 35:549-556.
23. Martinez-Martin P, Valldeoriola F. Pallidotomy and quality of life in patients with Parkinson's disease: an early study. Movement Disorders 2000; 15:67-70.
24. East-4. Software for the Design and Interim Monitoring of Flexible Clinical Trials. Cytel Software Corporation: Cambridge, MA, 2005.
25. Tsiatis AA, Mehta CR. On the inefficiency of the adaptive design for monitoring clinical trials. Biometrika 2003; 90:367-378.
26. Jennison C, Turnbull BW. Mid-course sample size modification in clinical trial. Statistics in Medicine 2003; 22:971-993.