Outcome substitution

• A clinically meaningful outcome: a direct measure of how a patient feels, functions or survives.

• A surrogate outcome: a laboratory measurement or a physical sign used as a substitute for a clinically meaningful outcome.

• A surrogate must:

  • be a correlate of the true clinical outcome and
  • fully capture the net effect of treatment on the clinical outcome

Prentice RL. Surrogate endpoints in clinical trials: definition and operational criteria. Statistics in Medicine 8:431-40, 1989.

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