Table of Contents
Clinical Trial Design for Heavily Treatment-Experienced Patients
Introduction
Issues
Today’s Objectives
Defining the “Heavily Treatment-Experienced” Population
How We Reached This Point
Trial Design Challenges
Where We Need to Go
FDA’s Role
FDA’s Focus
Request for Public Input: October 2000 Letter and FRN
Morning Agenda: Trial Design Issues
Afternoon Agenda: Endpoint Issues
Acknowledgements for Responses
Therapy for Treatment-Experienced Patients Working Group
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