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Exact Significance Testing to Establish Treatment Equivalence with Ordered Categorical Data
Abstract
This communication concerns the problem of establishing the therapeutic equivalence of two treatments that are being compared on the basis of ordered categorical data. The problem is formulated as a significance test in which the null hypothesis specifies a treatment difference. An efficient numerical algorithm for computing the exact significance level is provided, along with a simple method for obtaining the asymptotic significance level. Both methods are applied to a clinical trial of a new agent versus an active control. Guidelines for when to use the exact procedure and when to rely on asymptotic theory are provided.
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Cited by
Giantonio, B. J., Catalano, P. J., Meropol, N. J., O'Dwyer, P. J., Mitchell, E. P., Alberts, S. R., Schwartz, M. A., & Benson, A. B. (2007) · Journal of Clinical Oncology · doi:10.1200/jco.2006.09.6305 · Cited by 2,279
All-trans-Retinoic Acid in Acute Promyelocytic Leukemia
Tallman, M. S., Andersen, J. W., Schiffer, C. A., Appelbaum, F. R., Feusner, J. H., Ogden, A., Shepherd, L., Willman, C., Bloomfield, C. D., Rowe, J. M., et al. (1997) · New England Journal of Medicine · doi:10.1056/nejm199710093371501 · Cited by 1,073
A Multicenter, Controlled Trial of Ursodiol for the Treatment of Primary Biliary Cirrhosis
Poupon, R. E., Balkau, B., Eschwège, E., Poupon, R., & the UDCA–PBC Study Group* (1991) · New England Journal of Medicine · doi:10.1056/nejm199105303242204 · Cited by 755
Gribben, J. G., Freedman, A. S., Neuberg, D., Roy, D. C., Blake, K. W., Woo, S. D., Grossbard, M. L., Rabinowe, S. N., Coral, F., Freeman, G. J., et al. (1991) · New England Journal of Medicine · doi:10.1056/nejm199111283252201 · Cited by 668
Tallman, M. S. (2002) · Blood · doi:10.1182/blood-2002-02-0632 · Cited by 482
Metadata
- Authors
- Mehta, C. R., Patel, N. R., & Tsiatis, A. A.
- Venue
- Biometrics
- Publisher
- JSTOR
- Published
- 1984-09
- Volume
- 40
- Issue
- 3
- Pages
- 819
- ISSN
- 0006-341X (ISSN-L)
- OpenAlex
- W2090653702
- Cited by
- 328
- References
- 0
- FWCI
- 4.37
- Type
- journal article
- Language
- en
- Open access
- closed
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- CoChat. (2026). Citation check: Exact Significance Testing to Establish Treatment Equivalence with Ordered Categorical Data. https://app.cochat.ai/papers/10.2307/2530927
- The paper
- Mehta, C. R., Patel, N. R., & Tsiatis, A. A. (1984). Exact Significance Testing to Establish Treatment Equivalence with Ordered Categorical Data. Biometrics. https://doi.org/10.2307/2530927
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.