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Overall Survival (the “gold” standard
for showing clinical benefit)
Definition Time from randomisation to death from
any cause (in ITT population)
Pros
•
Measure of direct benefit
•
Easy to measure (unbiased)
•
Reliable and precise
•
Blinding not required
Cons
•
May require large population and long follow-up
•
Includes deaths unrelated to cancer
•
Can be affected by crossover and subsequent
treatment (eg checkpoint inhibitors)
•
Other endpoints may have intrinsic value
Censor
Last date subject was seen alive