Some remarks about the analysis of active control studies

Biometrical Journal

Volumn 47, Issue 5, 2005, Pages 616-622

  Lawrence, John ^a  

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

Author keywords

Interim analysis; Meta analysis

Indexed keywords

'CURRENT; ACTIVE CONTROL; CONFIDENCE INTERVAL; CONTROL STUDIES; CONTROLLED TRIAL; INTERIM ANALYSIS; META-ANALYSIS; NUISANCE PARAMETER; STATISTICAL PROPERTIES; TEST STATISTICS;

EID: 27844487969     PISSN: 03233847     EISSN: None     Source Type: Journal    
DOI: 10.1002/bimj.200410145     Document Type: Article

References (7)

1. Bross, P. F., Baird, A., Chen, G., Jee, J. M., Lostritto, R. T., Morse, D. E., Rosario, L. A., Williams, G. M., Yang, P., Rahman, A., Williams, G., and Pazdur, R. (2003). Fulvestrant in postmenopausal women with advanced breast cancer. Clinical Cancer Research 9, 4309-4317.
2. Halperin, J. L. and the Executive Steering Committee, on behalf of the SPORTIF III and V Study Investigators (2003). Ximelagatran compared with warfarin for prevention of thromboembolism in patients with non-valvular atrial fibrillation: rationale, objectives, and design of a pair of clinical studies and baseline patient characteristics (SPORTIF III and V). American Heart Journal 146, 431-438.
3. Hasselblad, V. and Kong, D. (2001). Statistical methods for comparison to placebo in active-control trials. Drug Information Journal 35, 435-449.
4. Holmgren, E. B. (1999). Establishing equivalence by showing that a prespecified percentage of the effect of the active control over placebo is maintained. Journal of Biopharmaceutical Statistics 9(4), 651-659.
5. Hung, H. M. J., Wang, S. J., Tsong, Y., Lawrence, J., and O'Neill, R. (2003). Some fundamental issues with non-inferiority testing in active controlled trials. Statistics in Medicine 22, 213-225.
6. Rothmann, M., Li, N., Chen, G., Chi, G., Temple, R., and Tsou H. (2003). Design and analysis of non-inferiority mortality trials in oncology. Statistics in Medicine 22, 239-264.
7. Snapinn, S. M. (2004). Alternatives for discounting in the analysis of noninferiority trials. Journal of Biopharmaceutical Statistics 14, 263-273.