Is Survival the Only Thing that Matters?
Is Survival the Only Thing that Matters?
Is Survival the Only Thing that Matters?
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Phase II<br />
• The purpose of a phase II is to<br />
demonstrate efficacy, <strong>the</strong>refore survival or<br />
a surrogate of survival is required<br />
– <strong>Survival</strong> may be difficult to demonstrate if<br />
• Long natural history of <strong>the</strong> cancer<br />
• Small sample size or limited activity<br />
• Anti-cancer agents are commonly<br />
approved based on phase II data
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