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Korn EL, Freidlin B. Conditional power calculations for clinical trials with historical controls. Stat Med. 2006;25(17):2922-31doi: 10.1002/sim.2516.
Korn, E. L., & Freidlin, B. (2006). Conditional power calculations for clinical trials with historical controls. Statistics in medicine, 25(17), 2922-31. https://doi.org/10.1002/sim.2516
Korn, Edward L, and Freidlin, Boris. "Conditional power calculations for clinical trials with historical controls." Statistics in medicine vol. 25,17 (2006): 2922-31. doi: https://doi.org/10.1002/sim.2516
Korn EL, Freidlin B. Conditional power calculations for clinical trials with historical controls. Stat Med. 2006 Sep 15;25(17):2922-31. doi: 10.1002/sim.2516. PMID: 16479548.
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Stat Med. 2006 Sep 15;25(17):2922-31. doi: 10.1002/sim.2516.

Conditional power calculations for clinical trials with historical controls.

Statistics in medicine

Edward L Korn, Boris Freidlin

Affiliations

  1. Biometric Research Branch, National Cancer Institute, Bethesda, MD 20892, USA. [email protected]

PMID: 16479548 DOI: 10.1002/sim.2516

Abstract

A trial of a new therapy is to be compared to results from a previous trial of patients treated with a standard therapy. For a given sample size for the trial of the new therapy, we desire the power, against a specific alternative hypothesis, for the hypothesis test of the null hypothesis that the therapies are equivalent. Alternatively, the sample size required for the trial of the new therapy is needed for a target power. We explain why a popular method for doing these calculations is wrong, and discuss alternative methods in the context of normal outcomes, binary outcomes, and time-to-event outcomes.

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