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A comparison of methods for treatment selection in seamless phase II/III clinical trials incorporating information on short-term endpoints

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A comparison of methods for treatment selection in seamless phase II/III clinical trials incorporating information on short-term endpoints. / Kunz, Cornelia Ursula; Friede, Tim; Parsons, Nicholas et al.
In: Journal of Biopharmaceutical Statistics, Vol. 25, No. 1, 2015, p. 170-189.

Research output: Contribution to Journal/Magazine › Journal article › peer-review

Harvard

Kunz, CU, Friede, T, Parsons, N, Todd, S & Stallard, N 2015, 'A comparison of methods for treatment selection in seamless phase II/III clinical trials incorporating information on short-term endpoints', Journal of Biopharmaceutical Statistics, vol. 25, no. 1, pp. 170-189. https://doi.org/10.1080/10543406.2013.840646

APA

Kunz, C. U., Friede, T., Parsons, N., Todd, S., & Stallard, N. (2015). A comparison of methods for treatment selection in seamless phase II/III clinical trials incorporating information on short-term endpoints. Journal of Biopharmaceutical Statistics, 25(1), 170-189. https://doi.org/10.1080/10543406.2013.840646

Vancouver

Kunz CU, Friede T, Parsons N, Todd S, Stallard N. A comparison of methods for treatment selection in seamless phase II/III clinical trials incorporating information on short-term endpoints. Journal of Biopharmaceutical Statistics. 2015;25(1):170-189. Epub 2015 Jan 20. doi: 10.1080/10543406.2013.840646

Author

Kunz, Cornelia Ursula ; Friede, Tim ; Parsons, Nicholas et al. / A comparison of methods for treatment selection in seamless phase II/III clinical trials incorporating information on short-term endpoints. In: Journal of Biopharmaceutical Statistics. 2015 ; Vol. 25, No. 1. pp. 170-189.

Bibtex

@article{1da0f9080d844a878c34a08aa8ca6723,
title = "A comparison of methods for treatment selection in seamless phase II/III clinical trials incorporating information on short-term endpoints",
abstract = "In an adaptive seamless phase II/III clinical trial interim analysis, data are used for treatment selection, enabling resources to be focused on comparison of more effective treatment(s) with a control. In this paper, we compare two methods recently proposed to enable use of short-term endpoint data for decision-making at the interim analysis. The comparison focuses on the power and the probability of correctly identifying the most promising treatment. We show that the choice of method depends on how well short-term data predict the best treatment, which may be measured by the correlation between treatment effects on short- and long-term endpoints.",
keywords = "Adaptive seamless design, Multi-arm multi-stage trial, Surrogate endpoints",
author = "Kunz, {Cornelia Ursula} and Tim Friede and Nicholas Parsons and Susan Todd and Nigel Stallard",
year = "2015",
doi = "10.1080/10543406.2013.840646",
language = "English",
volume = "25",
pages = "170--189",
journal = "Journal of Biopharmaceutical Statistics",
issn = "1054-3406",
publisher = "Taylor and Francis Ltd.",
number = "1",

}

RIS

TY - JOUR

T1 - A comparison of methods for treatment selection in seamless phase II/III clinical trials incorporating information on short-term endpoints

AU - Kunz, Cornelia Ursula

AU - Friede, Tim

AU - Parsons, Nicholas

AU - Todd, Susan

AU - Stallard, Nigel

PY - 2015

Y1 - 2015

N2 - In an adaptive seamless phase II/III clinical trial interim analysis, data are used for treatment selection, enabling resources to be focused on comparison of more effective treatment(s) with a control. In this paper, we compare two methods recently proposed to enable use of short-term endpoint data for decision-making at the interim analysis. The comparison focuses on the power and the probability of correctly identifying the most promising treatment. We show that the choice of method depends on how well short-term data predict the best treatment, which may be measured by the correlation between treatment effects on short- and long-term endpoints.

AB - In an adaptive seamless phase II/III clinical trial interim analysis, data are used for treatment selection, enabling resources to be focused on comparison of more effective treatment(s) with a control. In this paper, we compare two methods recently proposed to enable use of short-term endpoint data for decision-making at the interim analysis. The comparison focuses on the power and the probability of correctly identifying the most promising treatment. We show that the choice of method depends on how well short-term data predict the best treatment, which may be measured by the correlation between treatment effects on short- and long-term endpoints.

KW - Adaptive seamless design

KW - Multi-arm multi-stage trial

KW - Surrogate endpoints

U2 - 10.1080/10543406.2013.840646

DO - 10.1080/10543406.2013.840646

M3 - Journal article

C2 - 24697322

VL - 25

SP - 170

EP - 189

JO - Journal of Biopharmaceutical Statistics

JF - Journal of Biopharmaceutical Statistics

SN - 1054-3406

IS - 1

ER -