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Making Independence Work: Monitoring the Bevacizumab Colorectal Cancer Clinical Trial

In: Data Monitoring in Clinical Trials

Author

Listed:
  • Janet Wittes

    (Statistics Collaborative)

  • Eric Holmgren

    (Genentech Inc.)

  • Heidi Christ-Schmidt

    (Statistics Collaborative)

  • Alex Bajamonde

    (Genentech Inc.)

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

Suggested Citation

  • Janet Wittes & Eric Holmgren & Heidi Christ-Schmidt & Alex Bajamonde, 2006. "Making Independence Work: Monitoring the Bevacizumab Colorectal Cancer Clinical Trial," Springer Books, in: David L. DeMets & Curt D. Furberg & Lawrence M. Friedman (ed.), Data Monitoring in Clinical Trials, chapter 0, pages 360-367, Springer.
  • Handle: RePEc:spr:sprchp:978-0-387-30107-5_35
    DOI: 10.1007/0-387-30107-0_35
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