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Statistics in Oncology Series
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- Biostatistics for CliniciansOpen Archive
Randomized Phase II Trials: Time for a New Era in Clinical Trial Design
Journal of Thoracic OncologyVol. 5Issue 7p932–934Published in issue: July, 2010- Sumithra J. Mandrekar
- Daniel J. Sargent
Cited in Scopus: 45The classic single-arm oncology phase II trial designs for evaluating an experimental regimen/agent are limited by multiple sources of bias arising from the inability to separate trial effects (such as patient selection, trial eligibility, imaging techniques and assessment schedule, and treatment locations) from treatment effect on clinical outcomes. Changes in patient population based on biologic subsetting, newer imaging technologies, the use of alternative end points, constrained resources, and the multitude of promising therapies for a given disease make randomized phase II designs, with a concurrent control arm where necessary, attractive.
