Making Independence Work: Monitoring the Bevacizumab Colorectal Cancer Clinical Trial

Janet Wittes, Eric Holmgren, Heidi Christ-Schmidt and Alex Bajamonde
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Janet Wittes: Statistics Collaborative
Eric Holmgren: Genentech Inc.
Heidi Christ-Schmidt: Statistics Collaborative
Alex Bajamonde: Genentech Inc.

Chapter Case 29 in Data Monitoring in Clinical Trials, 2006, pp 360-367 from Springer

Abstract: Abstract Genentech’s phase III study of colorectal cancer aimed to show that administration of bevacizumab, its recombinant human anti-vascular endothelial growth factor antibody, to patients with metastatic colorectal cancer would reduce mortality. The four-member DMC was responsible for reviewing real-time safety data, selecting the experimental arm of the study at an interim analysis, and assessing efficacy at a second interim analysis. Genentech and the entire study team remained blinded to treatment allocation during the course of the trial. The study, which proceeded to its planned end, showed an estimated hazard ratio for death of 0.66 (p

Keywords: Colorectal Cancer; Interim Analysis; Metastatic Colorectal Cancer; Case Study Approach; Data Monitoring Committee (search for similar items in EconPapers)
Date: 2006
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Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-0-387-30107-5_35

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DOI: 10.1007/0-387-30107-0_35

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