FDA - ODAC Quality of Life Subcommittee

2/29/00


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Table of Contents

FDA - ODAC Quality of Life Subcommittee

PPT Slide

Why is defining “clinical significance” difficult?

What Clinical significance is NOT

General Classification for Methods Assessing Clinical Significance

Meaningful Change in Group Comparison

Meaningful Change in Individual Measurement

Clinical Interpretability

Proposal: A Unified Theory Approach

Is a Unified Approach Achievable / Simplistic?

Discussion

Author: Rochester