Meeting Agenda

10/10/2003

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Table of Contents

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)

Examples of endpoints in oncology

Accelerated approval

Evidence for Accelerated Approval

ODAC Meeting on: Accelerated Approvals(March 2003)

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

Tumor Response Rate

Tumor-Related Symptoms

Review of Presentation

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

Author: CDER USER

Home Page: http://www.fda.gov/cder/drug/cancer_endpoints/default.htm

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