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A comparison of two phase I trial designs
Abstract
Phase I cancer chemotherapy trials are designed to determine rapidly the maximum tolerated dose of a new agent for further study. A recently proposed Bayesian method, the continual reassessment method, has been suggested to offer an improvement over the standard design of such trials. We find the previous comparisons did not completely address the relative performance of the designs as they would be used in practice. Our results indicate that with the continual reassessment method, more patients will be treated at very high doses and the trials will take longer to complete. We offer some suggested improvements to both the standard design and the Bayesian method.
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Citations
Cited by
Dose Escalation Methods in Phase I Cancer Clinical Trials
Le Tourneau, C., Lee, J. J., & Siu, L. L. (2009) · JNCI: Journal of the National Cancer Institute · doi:10.1093/jnci/djp079 · Cited by 867
Continual Reassessment Method: A Likelihood Approach
O'Quigley, J., & Shen, L. Z. (1996) · Biometrics · doi:10.2307/2532905 · Cited by 382
Bayesian Optimal Interval Design: A Simple and Well-Performing Design for Phase I Oncology Trials
(2016) · doi:10.1158/1078-0432.ccr-16-0592 · Cited by 235
Operating characteristics of the standard phase I clinical trial design
Reiner, E., Paoletti, X., & O'Quigley, J. (1999) · Computational Statistics & Data Analysis · doi:10.1016/s0167-9473(98)00095-4 · Cited by 104
Metadata
- Authors
- Korn, E. L., Midthune, D., Chen, T. T., Rubinstein, L. V., Christian, M. C., & Simon, R. M.
- Venue
- Statistics in Medicine
- Publisher
- Wiley
- Published
- 1994-09-30
- Volume
- 13
- Issue
- 18
- Pages
- 1799-1806
- ISSN
- 0277-6715 (ISSN-L)
- 1097-0258
- OpenAlex
- W2125300671
- Cited by
- 303
- References
- 0
- FWCI
- 4.98
- Type
- journal article
- Language
- en
- Open access
- closed
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- Korn, E. L., Midthune, D., Chen, T. T., Rubinstein, L. V., Christian, M. C., & Simon, R. M. (1994). A comparison of two phase I trial designs. Statistics in Medicine. https://doi.org/10.1002/sim.4780131802
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