Breakfast Seminar: Paul Kluetz, FDA

Cancer therapies treat patients, not their disease, and FDA is working to identify rigorous methods to quantify symptoms and functional outcomes that are meaningful to cancer patients. Dr. Kluetz is a medical oncologist working within the Oncology Center of Excellence and will discuss the measurement of symptoms and physical function as a core expectation in cancer trials. He will discuss clinical outcome data that has contributed to FDA review of important cancer drugs and some of the challenges and opportunities in identifying a concept to measure, selecting the appropriate type of clinical outcome assessment, a fit for purpose instrument and a well-defined endpoint to address a clear study objective.

The Cancer Outcomes Research Program Breakfast Seminar Series is organized by Drs. Ethan Basch, Stephanie Wheeler, and Matthew Nielsen. Please arrive at 7:45am to join us for a hot breakfast buffet prior to the start of our 8:00am meeting. Parking is available at the Rams Head parking deck next door; we will give you vouchers to park for free.