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A New Design for Randomized Clinical Trials
Abstract
This paper proposes a new method for planning randomized clinical trials. This method is especially suited to comparison of a best standard or control treatment with an experimental treatment. Patients are allocated into two groups by a random or chance mechanism. Patients in the first group receive standard treatment; those in the second group are asked if they will accept the experimental therapy; if they decline, they receive the best standard treatment. In the analyses of results, all those in the second group, regardless of treatment, are compared with those in the first group. Any loss of statistical efficiency can be overcome by increased numbers. This experimental plan is indeed a randomized clinical trial and has the advantage that, before providing consent, a patient will know whether an experimental treatment is to be used.
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Cited by
Identification of Causal Effects Using Instrumental Variables
Angrist, J. D., Imbens, G. W., & Rubin, D. B. (1996) · Journal of the American Statistical Association · doi:10.1080/01621459.1996.10476902 · Cited by 4,230
Consort 2010 statement: extension to cluster randomised trials
Campbell, M. K., Piaggio, G., Elbourne, D. R., Altman, D. G., & for the CONSORT Group (2012) · BMJ · doi:10.1136/bmj.e5661 · Cited by 3,510
de Lorgeril, M., Salen, P., Martin, J.-L., Monjaud, I., Delaye, J., & Mamelle, N. (1999) · Circulation · doi:10.1161/01.cir.99.6.779 · Cited by 2,910
Mediterranean alpha-linolenic acid-rich diet in secondary prevention of coronary heart disease
de Lorgeril, M., Renaud, S., Salen, P., Monjaud, I., Mamelle, N., Martin, J. L., Guidollet, J., Touboul, P., & Delaye, J. (1994) · The Lancet · doi:10.1016/s0140-6736(94)92580-1 · Cited by 2,122
Why we need observational studies to evaluate the effectiveness of health care
Black, N. (1996) · BMJ · doi:10.1136/bmj.312.7040.1215 · Cited by 1,598
Metadata
- Authors
- Zelen, M.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 1979-05-31
- Volume
- 300
- Issue
- 22
- Pages
- 1242-1245
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W1980043956
- Cited by
- 1,055
- References
- 0
- FWCI
- 25.71
- Type
- journal article
- Language
- en
- Open access
- closed
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- CoChat. (2026). Citation check: A New Design for Randomized Clinical Trials. https://app.cochat.ai/papers/10.1056/nejm197905313002203
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- Zelen, M. (1979). A New Design for Randomized Clinical Trials. New England Journal of Medicine. https://doi.org/10.1056/nejm197905313002203
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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
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.
