Statistical monitoring of clinical trials with multivariate response and/or multiple arms: A flexible approach

Biostatistics

Volumn 10, Issue 2, 2009, Pages 310-323

  Zhao, Lihui ^a   Hu, X Joan ^a   Lagakos, Stephen W ^b  

^a SIMON FRASER UNIVERSITY   (Canada)

^b HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

Group sequential analysis; Interim review; Multiple comparisons; Multiple end points; Nonparametric inference; Repeated confidence bands

Indexed keywords

ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; VIRUS RNA;

ARTICLE; BLOOD; CD4 LYMPHOCYTE COUNT; COMPARATIVE STUDY; COMPUTER SIMULATION; CONFIDENCE INTERVAL; GENETICS; GROWTH, DEVELOPMENT AND AGING; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; METHODOLOGY; MULTIVARIATE ANALYSIS; RANDOMIZED CONTROLLED TRIAL; STATISTICAL ANALYSIS; VIROLOGY;

ANTI-HIV AGENTS; CD4 LYMPHOCYTE COUNT; COMPUTER SIMULATION; CONFIDENCE INTERVALS; DATA INTERPRETATION, STATISTICAL; HIV; HIV INFECTIONS; HUMANS; MULTIVARIATE ANALYSIS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RNA, VIRAL;

EID: 61449095663     PISSN: 14654644     EISSN: 14684357     Source Type: Journal    
DOI: 10.1093/biostatistics/kxn037     Document Type: Article

References (23)

1. BECKETT, N. S., PETERS, R., FLETCHER, A. E., STAESSEN, J. A., LIU, L., DUMITRASCU, D., STOYANOVSKY, V, ANTIKAINEN, R. L., NIKITIN, Y., ANDERSON, C. and others (2008). Treatment of Hypertension in patients 80 years of age or older. New England Journal of Medicine 358, 1887-1898.
2. BETENSKY, R. A. (1997). Sequential analysis of censored survival data with three treatment groups. Biometrics 53, 807-822.
3. COOK, R. J. (1994). Interim monitoring bivariate responses using repeated confidence intervals. Controlled Clinical Trials 15, 187-200.
4. DIGGLE, P. J., LIANG, K. Y. AND ZEGER, S. L. (1994). Analysis of Longitudinal Data. New York: Oxford University Press.
5. ELLENBERG, S.S., FLEMING, T. R. AND DEMETS, D. L. (2002). Data Monitoring Committees in Clinical Trials: A Practical Perspective. Chichester, UK: John Wiley.
6. GULICK, R. M., HU, X. J., FISCUS, S. A., COURTNEY, V. F., HAUBRICH, R., CHENG, H., SCOSTA, E., LAGAKOS, S. W., SWANSTORM, R., FREIMUTH, W. and others (2000). Randomized study of saquinavir with ritonavir or nelfinavir together with delavirdine, adefovir, or both in human immunodeficiency virus-infected adults with virologie failure in indinavir: AIDS clinical trials group study 359. The Journal of Infectious Diseases 182, 1375-1384.
7. HELLMICH, M. (2001). Monitoring clinical trials with multiple arms. Biometrics 57, 892-898.
8. HU, X. J. AND LAGAKOS, S. W. (1999a). Group sequential analyses for the mean function of a repeated measure process. Statistics in Medicine 18, 2287-2299.
9. HU, X. J. AND LAGAKOS, S.W. (1999b). Interim analysis using repeated confidence bands. Biometrika 86, 517-529.
10. HU, X. J. AND LAGAKOS, S. W. (2007). Nonparametric estimation of the mean function of a stochastic process with missing observations. Lifetime Data Analysis 13, 51-73.
11. HUGHES, M. D. (1993). Stopping guidelines for clinical trials with multiple treatments. Statistics in Medicine 12, 901-915.
12. JENNISON, C. AND TURNBULL, B. W. (1989). Interim, analyses: the repeated confidence interval approach (with discussion). Journal of the Royal Statistical Society, Series B 51, 305-361.
13. JENNISON, C. AND TURNBULL, B. W. (2000). Group Sequential Methods with Applications to Clinical Trials. Boca Raton, FL: Chapman and Hall.
14. KOSOROK, M. R., SHI, Y. AND DEMETS, D. L. (2004). Design and analysis of group sequential clinical trials with multiple primary endpoints. Biometrics 60, 134-145.
15. LAN, K. K. G. AND DEMETS, D. L. (1983). Discrete sequential boundaries for clinical trials. Biometrika 70, 659663.
16. LIN, D. Y, WEI, L. J. AND YING, Z. (1993). Checking the Cox model with cumulative sums of martingale-based residuals. Biometrika 80, 557-572.
17. NATIONAL EMPHYSEMA TREATMENT TRIAL RESEARCH GROUP (2003). A randomized trial comparing lung-volume reduction surgery with medical therapy for severe emphysema. The New England Journal of Medicine 348, 2059-2073.
18. PROSCHAN, M. A., FOLLMANN, D. A. AND GELLER, N. L. (1994). Monitoring multi-armed trials. Statistics in Medicine 13, 1441-1452.
19. PROSCHAN, M. A., LAN, K. K. G. AND WITTES, J. T. (2006). Statistical Monitoring of Clinical Trials: A Unified Approach. New York: Springer.
20. TESTOSTERONE AND AGING: CLINICAL RESEARCH DIRECTIONS (2003). In: Liverman, C. T. and Blazer, D. G. (editors), IOMReport. Washington, DC: National Academics Press.
21. WEI, L. J., SU, J. Q. AND LACHIN, J. M. (1990). Interim analyses with repeated measurements in a sequential clinical trial. Biometrika 77, 359-364.
22. WHITEHEAD, J. (1997). The Design and Analysis of Sequential Clinical Trials, 2nd edition. Chichester, UK: John Wiley.
23. WILLIAMS, P. L. (1996). Sequential monitoring of clinical trials with multiple survival endpoints. Statistics in Medicine 15, 2341-2357.