Table of Contents
Meeting Agenda
Presentations
Outline of Presentation
Requirements for Drug Approval
How many trials?
Oncology Efficacy Supplements
Regular Approval Endpoints in Oncology
Clinical Benefit Endpoints Supporting Oncology Drug Approval
Established Surrogates Supporting Approval
DODP: Endpoints for Approval (1/1/90 - 11/1/02)
PPT Slide
Examples of endpoints in oncology
Accelerated approval
PPT Slide
Evidence for Accelerated Approval
ODAC Meeting on: Accelerated Approvals(March 2003)
PPT Slide
ODAC Meeting on: Accelerated Approvals(March 2003)
Single Arm Trials (SAT) and Accelerated approval (AA)
Randomized Trials (RT) and Accelerated approval (AA)
Endpoints and Issues
Survival
PPT Slide
Tumor Response Rate
PPT Slide
PPT Slide
PPT Slide
PPT Slide
Tumor-Related Symptoms
Review of Presentation
PPT Slide
Endpoints Discussion
1. What are the Pros and Cons of each end point:
2. For each endpoint, what are the important trial design issues?
Classical Endpoints
Non-classical endpoints
Treatment settings
Trial designs
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Author: CDER USER
Home Page: http://www.fda.gov/cder/drug/cancer_endpoints/default.htm
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