Review and evaluation of methods for computing confidence intervals for the ratio of two proportions and considerations for non-inferiority clinical trials

Journal of Biopharmaceutical Statistics

Volumn 15, Issue 1, 2005, Pages 85-107

  Dann, Rebekkah S ^a   Koch, Gary G ^a  

^a IL   (United States)

Author keywords

Approximate confidence interval; Noninferiority; Power simulations; Risk ratio; Sample size; Type I error

Indexed keywords

ANALYTICAL ERROR; CALCULATION; CLINICAL STUDY; CONFIDENCE INTERVAL; EVALUATION; MATHEMATICAL ANALYSIS; MAXIMUM LIKELIHOOD METHOD; PERFORMANCE; PRIORITY JOURNAL; PROPORTION; RATIO; REVIEW; RISK; SAMPLE SIZE; SIMULATION; STATISTICAL ANALYSIS; VARIANCE;

CHI-SQUARE DISTRIBUTION; CLINICAL TRIALS; CONFIDENCE INTERVALS; HUMANS;

EID: 12344319606     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-200040844     Document Type: Review

References (13)

1. Agresti, A., Coull, B. A. (1998). Approximate is better than 'exact' for interval estimation of binomial proportions. Am. Statist. 52:119-126.
2. Bailey, B. J. R. (1987). Confidence limits to the risk ratio. Biometrics 43:201-205.
3. Blackwelder, W. C. (1982). Proving the null hypothesis in clinical trials. Control. Clin. Trials 3:345-353.
4. EquivTest 1.0. (2000). Software for the Statistical Analysis of Equivalence and Bioavailability Studies. Cork, Ireland: Statistical Solutions Ltd.
5. 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 non-unity relative risk. Stat. Med. 9:1447-1454.
6. Fieller, E. C. (1944). A fundamental formula in the statistics of biological assay and some applications. Q. J. Pharm. Pharmacol. 17:117-123.
7. Gart, J. J., Nam, J. (1988). Approximate interval estimation of the ratio of binomial parameters: a review and corrections for skewness. Biometrics 44:323-338.
8. Hung, H. M. J., Wang, S. J., Tsong, Y., Lawrence, J., O'Neill, R. T. (2001). Some fundamental issues with non-inferiority testing in active controlled trials. Stat. Med. 22:213-225.
9. Katz, D., Baptista, J., Azen, S. P., Pike, M. C. (1978). Obtaining confidence intervals for the risk ratio in cohort studies. Biometrics 34:469-474.
10. Koopman, P. A. R. (1984). Confidence intervals for the ratio of two binomial proportions. Biometrics 40:513-517.
11. nQuery Advisor Version 5.0 User's Guide. Cork, Ireland: Statistical Solutions Ltd.
12. SAS/STAT User's Guide. Vol. I. Version 6. Gary, North Carolina: SAS Institute Inc., pp. 871-872.
13. StatXact4 for Windows User Manual. Cambridge, Massachusetts: CYTEL Software Corporation, pp. 435-452.