Is Survival the Only Thing that Matters?

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Who cares about endpoints? • Industry – Initial FDA approval>market niche • USA: FDA – Typically approves new drugs after phase III comparisons to standard of care – Patient benefit with favorable risk/benefit profile – Approvals are commonly based on phase II data and symptom control • Other countries – Generally a decision of payer, whether therapy makes clinical and economic sense – Same or more rigorous evaluation of efficacy and toxicity • Prescribers • Patient
Endpoints • Efficacy driven endpoints • Survival – The real endpoint • Surrogate endpoints – response, progression free survival, disease free survival • Toxicity driven endpoints – Quality of life – Symptom control
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 14 and 15: Endpoints • Desired endpoints var
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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