A Comparison of Methods for Treatment Selection in Seamless Phase II/III Clinical Trials Incorporating Information on Short-Term Endpoints
2015 | journal article. A publication with affiliation to the University of Göttingen.
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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, C. U.; Friede, T.; Parsons, N.; Todd, S. & Stallard, N. (2015)
Journal of Biopharmaceutical Statistics, 25(1) pp. 170-189. DOI: https://doi.org/10.1080/10543406.2013.840646
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Details
- Authors
- Kunz, Cornelia Ursula; Friede, Tim; Parsons, Nicholas; Todd, Susan; Stallard, Nigel
- 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.
- Issue Date
- 2015
- Status
- published
- Publisher
- Taylor & Francis Inc
- Journal
- Journal of Biopharmaceutical Statistics
- ISSN
- 1520-5711; 1054-3406
- Sponsor
- UK Medical Research Council [G1001344]