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Journal of Biopharmaceutical Statistics Volume 8, 1998 - Issue 2
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Original Articles

On the use of the ratio or the odds ratio of cure rates in therapeutic equivalence clinical trials with binary endpoints

Dongsheng Tu Clinical Trials Group National Cancer Institute of Canada, Queen's University, 82-84 Barrie Street, Kingston, Ontario, K7L3N6, Canada
Pages 263-282 | Published online: 29 Mar 2007

Citations (35)

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Read on this site (13)

Kung-Jong Lui. (2018) Notes on Use of the Odds Ratio under the Sequential Parallel Comparison Design with Binary Outcomes. Statistics in Biopharmaceutical Research 10:3, pages 213-219.
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Kung-Jong Lui. (2016) Notes on Interval Estimation of Odds Ratio in Matched Pairs under Stratified Sampling. Communications in Statistics - Simulation and Computation 45:7, pages 2562-2576.
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Kung-Jong Lui & Chii-Dean Lin. (2014) Notes on Test Homogeneity of the Odds Ratio in Matched Pairs Under Stratified Sampling: A Monte Carlo Evaluation. Communications in Statistics - Simulation and Computation 43:10, pages 2403-2414.
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Kung-Jong Lui & Kuang-Chao Chang. (2013) Notes on Testing Noninferiority in Ordinal Data Under the Parallel Groups Design. Journal of Biopharmaceutical Statistics 23:6, pages 1294-1307.
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Kung-Jong Lui & Kuang-Chao Chang. (2012) Interval Estimation of the Proportion Ratio in Repeated Binary Measurements Under a Stratified Randomized Clinical Trial with Noncompliance. Journal of Biopharmaceutical Statistics 22:1, pages 109-132.
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Muhtarjan Osman & SujitK. Ghosh. (2011) Semiparametric Bayesian Testing Procedure for Noninferiority Trials with Binary Endpoints. Journal of Biopharmaceutical Statistics 21:5, pages 920-937.
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Kung-Jong Lui & Kuang-Chao Chang. (2010) Test Non-Inferiority and Sample Size Determination Based on the Odds Ratio Under a Cluster Randomized Trial with Noncompliance. Journal of Biopharmaceutical Statistics 21:1, pages 94-110.
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Kung-Jong Lui & Kuang-Chao Chang. (2010) Notes on odds ratio estimation for a randomized clinical trial with noncompliance and missing outcomes. Journal of Applied Statistics 37:12, pages 2057-2071.
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Muhtarjan Osman & SujitK. Ghosh. (2010) Novel Bayesian Methods for Non-Inferiority Tests Based on Relative Risk and Odds Ratio for Dichotomous Data. Journal of Statistical Theory and Practice 4:3, pages 433-452.
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Kung-Jong Lui & Kuang-Chao Chang. (2009) Test Homogeneity of Odds Ratio in a Randomized Clinical Trial with Noncompliance. Journal of Biopharmaceutical Statistics 19:5, pages 916-932.
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Hansheng Wang, Shein-Chung Chow & Gang Li. (2002) ON SAMPLE SIZE CALCULATION BASED ON ODDS RATIO IN CLINICAL TRIALS. Journal of Biopharmaceutical Statistics 12:4, pages 471-483.
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Ludwig A. Hothorn & Dieter Hauschke. (2000) IDENTIFYING THE MAXIMUM SAFE DOSE: A MULTIPLE TESTING APPROACH. Journal of Biopharmaceutical Statistics 10:1, pages 15-30.
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David R. Bristol. (1999) CLINICAL EQUIVALENCE. Journal of Biopharmaceutical Statistics 9:4, pages 549-561.
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Articles from other publishers (22)

Kung-Jong Lui. (2018) Asymptotic and exact interval estimators of the common odds ratio under the sequential parallel comparison design. Statistical Methods in Medical Research 28:10-11, pages 3074-3085.
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Mingan Yang. (2018) Assessment of Noninferiority (and Equivalence) for Simple Crossover Trials Using Bayesian Approach. Statistics in Biosciences 10:3, pages 506-519.
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Kung-Jong Lui. (2018) Sample Size Determination for a 3-Treatment 3-Period Crossover Trial in Frequency Data. Therapeutic Innovation & Regulatory Science 52:4, pages 407-415.
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Kung‐Jong Lui. 2016. Crossover Designs. Crossover Designs 208 215 .
Kung-Jong Lui & Kuang-Chao Chang. (2016) Notes on testing noninferiority in multivariate binary data under the matched-pair design. Statistical Methods in Medical Research 25:4, pages 1272-1289.
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Arminda Lucia Siqueira, Susan Todd & Anne Whitehead. (2014) Sample size considerations in active-control non-inferiority trials with binary data based on the odds ratio. Statistical Methods in Medical Research 24:4, pages 453-461.
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George Y. H. Chi. 2015. Applied Statistics in Biomedicine and Clinical Trials Design. Applied Statistics in Biomedicine and Clinical Trials Design 203 234 .
Dongsheng Tu. 2012. Encyclopedia of Biopharmaceutical Statistics, Third Edition. Encyclopedia of Biopharmaceutical Statistics, Third Edition 917 921 .
Kung-Jong Lui. (2012) Notes on testing non-inferiority under the partial verification design with a confirmatory procedure limited to screen positives. Contemporary Clinical Trials 33:3, pages 563-571.
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Kung-Jong Lui & Kuang-Chao Chang. (2012) Exact sample-size determination in testing non-inferiority under a simple crossover trial. Pharmaceutical Statistics 11:2, pages 129-134.
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Kung‐Jong Lui & Kuang‐Chao Chang. (2011) Test non‐inferiority (and equivalence) based on the odds ratio under a simple crossover trial. Statistics in Medicine 30:11, pages 1230-1242.
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Kung‐Jong Lui. 2011. Binary Data Analysis of Randomized Clinical Trials with Noncompliance. Binary Data Analysis of Randomized Clinical Trials with Noncompliance 289 302 .
Shein-Chung ChowDongsheng Tu. 2010. Encyclopedia of Biopharmaceutical Statistics. Encyclopedia of Biopharmaceutical Statistics 917 921 .
Steven Julious. 2009. Sample Sizes for Clinical Trials. Sample Sizes for Clinical Trials 269 275 .
Kung-Jong Lui & Kuang-Chao Chang. (2009) Interval estimation of odds ratio in a stratified randomized clinical trial with noncompliance. Computational Statistics & Data Analysis 53:7, pages 2754-2766.
Crossref
Tie‐Hua Ng. (2008) Noninferiority hypotheses and choice of noninferiority margin. Statistics in Medicine 27:26, pages 5392-5406.
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Valentin Rousson & Burkhardt Seifert. (2008) A Mixed Approach for Proving Non‐Inferiority in Clinical Trials with Binary Endpoints. Biometrical Journal 50:2, pages 190-204.
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Arminda Lucia Siqueira, Anne Whitehead & Susan Todd. (2007) Active‐control trials with binary data: A comparison of methods for testing superiority or non‐inferiority using the odds ratio. Statistics in Medicine 27:3, pages 353-370.
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. (2007) Idraparinux versus Standard Therapy for Venous Thromboembolic Disease. New England Journal of Medicine 357:11, pages 1094-1104.
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Andrew D. Garrett. (2003) Therapeutic equivalence: fallacies and falsification. Statistics in Medicine 22:5, pages 741-762.
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Robert M. Christley & Stuart W. J. Reid. (2003) No significant difference: use of statistical methods for testing equivalence in clinical veterinary literature. Journal of the American Veterinary Medical Association 222:4, pages 433-437.
Crossref
Brian L. Wiens & Boris Iglewicz. (2001) Testing Noninferiority of Response Rates for Regulatory Filings Using Transformations. Drug Information Journal 35:4, pages 1165-1171.
Crossref

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