Type I error probabilities based on design-stage strategies with applications to noninferiority trials

Journal of Biopharmaceutical Statistics

Volumn 15, Issue 1, 2005, Pages 109-127

  Rothmann, Mark ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Active controlled trials; Noninferiority trials

Indexed keywords

ARTICLE; CALCULATION; CLINICAL STUDY; CONFIDENCE INTERVAL; ERROR; HYPOTHESIS; PRIORITY JOURNAL; PROBABILITY; SAMPLE SIZE; STATISTICAL ANALYSIS;

CONTROLLED CLINICAL TRIALS; HUMANS; PROBABILITY; RESEARCH DESIGN;

EID: 12344284172     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-200040847     Document Type: Article

References (10)

1. Ellenberg, S., Temple, R. (2000). Placebo controlled trials and active-control trials in the evaluation of new treatments. Part 2. Practical issues and specific cases. Ann. Intern. Med. 133:464-470.
2. FDA Medical-Statistical review for Xeloda (NDA 20-896) dated April 23, 2001.
3. Fleming, T. (1990). Evaluation of active control trials in AIDS. J. AIDS 3(S2): S82-S87.
4. Fleming, T. R., Harrington, D. (1991). Counting Processes and Survival Analysis. New York: Wiley.
5. Follmann, D., Proschan, M. (1999). Valid inference in random effects meta-analysis. Biometrics 55:732-737.
6. Rothmann, M., Li, N., Chen, G., Chi, G., Tsou, H. (2001). Non-inferiority methods for mortality trials. In: Proceedings of the American Statistical Association Biopharmaceutical Section. Mira Digital Publishing 1-6.
7. Rothmann, M., Li, N., Chen, G., Chi, G., Temple, R., Tsou, H. (2003). Design and analysis of non-inferiority mortality trials in oncology. Stat. Med. 22(2):239-264.
8. Satterthwaite, F. (1946). An approximate distribution of estimates of variance components. Biometrics 2:110-114.
9. Temple, R., Ellenberg, S. (2000). Placebo controlled trials and active-control trials in the evaluation of new treatments. Part 1. Ethical and scientific issues. Ann. Intern. Med. 133:455-463.
10. Wei, L. J., Gail, M. (1983). Nonparametric estimation for a scale-change with censored observations. J. Am. Stat. Assoc. 78:382-388.