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Randomized Phase II Trials: Time for a New Era in Clinical Trial Design
2010
Journal of Thoracic Oncology
The 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,
doi:10.1097/jto.0b013e3181e2eadf
pmid:20581575
pmcid:PMC2941394
fatcat:pbadvsdwzrf2biiqy6czotgqme