Phase II Study Designs

11/30/01


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Table of Contents

PPT Slide

Phase II Study Designs

Therapeutic Intent

Scientific Validity of Phase II Windows

Impact: Classic Phase II Trials

Not all agents active in classic phase II trials improve survival

Too early to judge impact of window phase II studies Long developmental cycle

Patient Benefits: Phase II Windows

Phase II Windows: Agent selection

Phase II Windows: Patient selection

Phase II Windows: Consent

Phase II Windows: Summary

Consensus meeting July 22, 1997 Points to Consider

Risks and Benefits

Informed Consent

Informed Consent

Author: Althea M Roberts