Endpoints for Colon Adjuvant Clinical Trials: Recommendations Based on Individual Patient Data from 20898 Patients and 18 Randomized Trials

Daniel Sargent PhD
Director, Cancer Center Statistics, Mayo Clinic Cancer Center
Consultant, Mayo Clinic Division of Biostatistics

Wednesday, November 2nd
3:30pm
Moos 2-690
Minneapolis Campus

Abstract:

The traditional endpoint for colon adjuvant clinical trials is overall survival after 5 years of follow-up. A validated shorter-term (surrogate) endpoint could significantly speed the translation of advances into clinical practice. We present methodology and results from an analysis exploring a variety of possible surrogate endpoints using both simple and complex statistical methods using individual patient data from 18 phase III clinical trials involving almost 21000 patients. The results have led to a change in US FDA policy regarding the approval of agents for colon cancer.

A social tea will be held at 3:00 P.M. in A434 Mayo. All are Welcome.
For more details contact 612-624-4655 or see http://www.biostat.umn.edu/seminar_academic.html