Testing for interaction in studies of noninferiority

Journal of Biopharmaceutical Statistics

Volumn 13, Issue 1, 2003, Pages 103-115

  Wiens, Brian L ^a   Heyse, Joseph F ^b  

^a AMGEN INC   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Equivalence; Min test; Qualitative interaction; Stratification

Indexed keywords

ARTICLE; CLINICAL TRIAL; DRUG RESEARCH; HYPOTHESIS; METHODOLOGY; PRIORITY JOURNAL; QUALITATIVE ANALYSIS; STANDARD; STATISTICAL SIGNIFICANCE; STRATIFICATION;

BIAS (EPIDEMIOLOGY); COMPUTER SIMULATION; CONFIDENCE INTERVALS; DATA INTERPRETATION, STATISTICAL; HUMANS; LACTONES; MODELS, STATISTICAL; PEPTIC ULCER; RANDOMIZED CONTROLLED TRIALS; SULFONES;

EID: 0037287752     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-120017729     Document Type: Article

References (12)

1. Blackwelder, W. C. (1982). 'Proving the Null Hypothesis' in clinical trials. Control. Clin. Trials 3:345-353.
2. Breslow, N., Day, N. (1980). Statistical Methods in Cancer Research, Volume 1: The Analysis of Case-Control Studies. Lyon: International Agency for Research on Cancer.
3. DuBois, D., Wiens, B. L. (1999). The Breslow-Day test as a precursor to a stratified test of equivalence. American Statistical Association 1999 Proceedings of the Biopharmaceutical Section. Arlington, Virginia: American Statistical Association, pp. 175-178.
4. Farrington, C. P., Manning, G. (1990). Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or nonunity relative risk. Stat. Med. 9:1447-1454.
5. Fleiss, J. L. (1986). The Design and Analysis of Clinical Experiments. New York: John Wiley & Sons.
6. Gail, M., Simon, R. (1985). Testing for qualitative interaction between treatment effects and patient subsets. Biometrics 41:361-372.
7. Hawkey, C., Laine, L., Simon, T., Beaulieu, A., Maldonado-Cocco, J., Acevedo, E., Cello, J., Shahane, A., Quan, H., Bolognese, J., Mortensen, E. (2000). A comparison of the effect of rofecoxib (a COX-2 specific inhibitor), ibuprofen, or placebo on the gastroduodenal mucosa of osteoarthritics. Arthritis Rheumatism 43:370-377.
8. Hawkey, C. J., Laine, L., Harper, S. E., Quan, H., Bolognese, J. A., Mortensen, E., Lines, C. R., Simon, T. J. [for the Rofecoxib Osteoarthritis Endoscopy Multinational Study Group] (2001). Influence of risk factors on endoscopic and clinical ulcers in patients taking rofecoxib or Ibuprofen in two randomized controlled trials. Elementary Pharmacol. Ther. 15:1593-1601.
9. Laine, L., Harper, S., Simon, T., Bath, R., Johanson, J., Schwartz, H., Stern, S., Quan, H., Bolognese, J. (1999). A randomized trial comparing the effect of rofecoxib, a cyclooxygenase 2-specific inhibitor, with that of ibuproferi on the gastroduodenal mucosa of patients with osteoarthritis. Gastroenterology 117:776-783.
10. Laska, N. S., Meisner, M. J. (1989). Testing whether an identified treatment is best. Biometrics 45:1139-1151.
11. Quan, H., Shih, W.J. Treatment by Stratum Interaction Test for Equivalence Trials. Merck Research Laboratories Technical Report # 84, October, 2002.
12. Wiens, B. L. (2002). Choosing an equivalence limit for noninferiority or equivalence studies. Control. Clin. Trials 23:2-14.