Regulatory Background
Acknowledgements
Workshop outline
Outline of Presentation
Requirements for Drug Approval
How many trials?
Oncology Efficacy Supplements
Regular Approval Endpoints in Oncology
Clinical Benefit Endpoints Supporting Regular Drug Approval
Established Surrogates Supporting Regular Approval
DODP: Endpoints for Approval (1/1/90 - 11/1/02)
PPT Slide
Tumor-related symptoms
Accelerated approval
Evidence for Accelerated Approval
Single Arm Trials (SAT) and Accelerated approval (AA)
Randomized Trials (RT) and Accelerated approval (AA)
ODAC Meeting on: Accelerated Approvals (March 2003)
Summary of Presentation
Home Page: http://www.fda.gov/cder/drug/cancer_endpoints/default.htm
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