Is Survival the Only Thing that Matters?

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Endpoints • Desired endpoints vary with phase of testing and clinical situation – Phase I vs III • Measure of exposure versus improved outcome – Adjuvant vs Metastatic • Survival vs quality of life or symptom control
Surrogate Markers • Replace a distal endpoint (survival) by proxy endpoint (response, biomarkers) • Benefits of using surrogate markers – Reduction in sample size – Reduction in trial duration – Reduction in cost – Reduction in time to evaluate new therapies • Their use is NOT AS EASY AS IT SOUNDS… • Use of a marker as surrogate for outcome requires that you first identify one...
Page 1 and 2: Drug Development and Acceptance: Is
Page 3 and 4: Eschenbach, Plenary Presentation AA
Page 10 and 11: Oncology: What is changing? • Com
Page 12 and 13: Who cares about endpoints? • Indu
Page 16 and 17: What is a surrogate marker? • Def
Page 18 and 19: Correlative Studies • It is still
Page 20 and 21: Phase I Endpoints •The only reaso
Page 22 and 23: Phase II • The purpose of a phase
Page 24 and 25: Classification of Standard Cytotoxi
Page 26 and 27: Study Endpoints- Response Rates •
Page 28 and 29: Phase III Endpoints • The purpose
Page 30 and 31: Study Endpoints-Survival Total Mort
Page 32 and 33: Case #1 • Gemcitabine for the tre
Page 34: Conclusions • Targeted therapies

Is Survival the Only Thing that Matters?

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