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Statistics in Oncology Series
2 Results
- Biostatistics For CliniciansOpen Archive
All-Comers versus Enrichment Design Strategy in Phase II Trials
Journal of Thoracic OncologyVol. 6Issue 4p658–660Published in issue: April, 2011- Sumithra J. Mandrekar
- Daniel J. Sargent
Cited in Scopus: 20Designs for biomarker validation have been proposed and used in the phase III oncology clinical trial setting. Broadly, these designs follow either an enrichment (i.e., targeted) strategy or an all-comers (i.e., unselected) strategy. An enrichment design screens patients for the presence or absence of a marker or a panel of markers and then only includes patients who either have or do not have a certain marker characteristic or profile. In contrast, all patients meeting the eligibility criteria (regardless of a particular biomarker status) are entered into an all-comers design. - 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.
