Historical Perspective, Selection and Implications of Delta * * *

2/25/02


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Table of Contents

Historical Perspective, Selection and Implications of Delta * * *

Advisory Committee meeting originally scheduled 9/13/01

Overview

Delta and Regulatory Decision

Delta and Regulatory Decision (2)

Delta and Regulatory Decision (3)

Historical Perspective

1992 PTC suggested 95% CI approach, delta based on observed success rate

1992 PTC: Design and conduct of clinical trial influenced by various factors

1992 PTC

Over the years….

Clinical Trial Implications: 1992 Points to Consider approach

Clinical Trial Implications: Smaller Delta (e.g. 10%)

Clinical Trial Implications: Smaller Delta (e.g. 5%)

Clinical Trial Implications:

Clinical Trial Implications: Sample size per arm to achieve 80% power

Clinical Trial impact on:

Consequence to Patients

Consequence to Patients

Consequence to Patients

Consequence to Patients

Summary

Author: CDER/USER