On tests of equivalence via non-unity relative risk for matched-pair design
Abstract
Matched-pair design is often used in clinical trials to increase the efficiency of treatment comparison. We consider the problem of equivalence test with a relative risk endpoint in matched-pair studies with binary outcomes, and develop several score and Wald-type statistics for testing a hypothesis of non-unity relative risk. Examples from an assessment of HIV screening test and a cross-over clinical trial of soft contact lenses are used to illustrate the proposed methods. Through simulations we compare the empirical performance of these tests with the test proposed by Lachenbruch and Lynch. We show that a score test based on a reparameterized multinomial model by Tango performs best in the sense that the test satisfactorily controls the type I error rate and its empirical type I error rates are generally much closer to the prespecified nominal significance level than those of the other tests.
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Clinical sensitivity and specificity values for CIN2+ were compared using a non-inferiority score test with relative sensitivity threshold 90% and relative specificity threshold 98% as proposed in consensus guidelines.
“Clinical sensitivity and specificity values for CIN2+ of Anyplex TM II HPV HR Detection were compared to those of GP5+6+-PCR using a non-inferiority score test, as described by Tang et al. [6], with a relative sensitivity threshold for CIN2+ of 90% and a relative specificity threshold for CIN2+ of 98% as proposed in the consensus guidelines [1].”
From Clinical validation of Anyplex™ II HPV HR Detection according to the guidelines for HPV test requirements for cervical cancer screening (2016) · cites this paper as [6]
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Schuirmann, D. J. (1987) · Journal of Pharmacokinetics and Biopharmaceutics · doi:10.1007/bf01068419 · Cited by 2,696 · see citing works
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VALGENT: a protocol for clinical validation of human papillomavirus assays
Arbyn, M., Depuydt, C., Benoy, I., Bogers, J., Cuschieri, K., Schmitt, M., Pawlita, M., Geraets, D., Heard, I., Gheit, T., et al. (2016) · Journal of Clinical Virology · doi:10.1016/j.jcv.2015.09.014 · Cited by 157 · see citing works
Hesselink, A. T., Sahli, R., Berkhof, J., Snijders, P. J. F., van der Salm, M. L., Agard, D., Bleeker, M. C. G., & Heideman, D. A. M. (2016) · Journal of Clinical Virology · doi:10.1016/j.jcv.2016.01.009 · Cited by 61 · see citing works
Cuschieri, K., Geraets, D., Cuzick, J., Cadman, L., Moore, C., Vanden Broeck, D., Padalko, E., Quint, W., & Arbyn, M. (2016) · Journal of Clinical Microbiology · doi:10.1128/jcm.00897-16 · Cited by 55 · see citing works
Assessment of the Roche Linear Array HPV Genotyping Test within the VALGENT framework
Xu, L., Oštrbenk, A., Poljak, M., & Arbyn, M. (2018) · Journal of Clinical Virology · doi:10.1016/j.jcv.2017.12.001 · Cited by 45 · see citing works
Oštrbenk Valenčak, A., Cuschieri, K., Connor, L., Zore, A., Smrkolj, Š., & Poljak, M. (2024) · Journal of Clinical Virology · doi:10.1016/j.jcv.2023.105638 · Cited by 20 · see citing works
- Authors
- Tang, N., Tang, M., & Chan, I. S. F.
- Affiliations
- Chinese University of Hong Kong (HK)
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- Corresponding author
- Chan, Ivan Siu Fung
- ORCID
- Tang, Man‐Lai
- Venue
- Statistics in Medicine
- Publisher
- Wiley
- Published
- 2003-03-18
- Volume
- 22
- Issue
- 8
- Pages
- 1217-1233
- ISSN
- 0277-6715 (ISSN-L)
- 1097-0258
- OpenAlex
- W2055327161
- Cited by
- 104
- References
- 1
- Citations by year
- 2026: 3 · 2025: 5 · 2024: 5 · 2023: 4 · 2022: 9 · 2021: 8 · 2020: 3 · 2019: 6 · 2018: 3 · 2017: 6 · 2016: 5 · 2015: 7 · 2014: 6 · 2013: 3 · 2012: 5
- FWCI
- 4.77
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Statistics in Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Physical Sciences › Mathematics › Statistics and Probability › Probability and Statistical Research
- Keywords
- equivalence testing, paired design, binary outcomes, score test, Wald test, type I error control, soft contact lenses
- MeSH terms
- Clinical Trials as Topic, Contact Lenses, Humans, Research Design, Models, Statistical, AIDS Serodiagnosis, HIV Infections, Case-Control Studies, Cross-Over Studies
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