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U.S. National Institutes of Health
Last Updated: 03/05/10

Step 5 — Clinical utility assessment

  • This step is basically a reiteration of Step 3 with refinement of the clinical question. The intended use should be more clearly defined and careful statistical designs applied to studies that usually have to include larger numbers of cases.
  • Proceed with a hypothesis-testing trial.

Steps 4 and 5 in practice are repeated, with refinements, probably 2-3 times prior to final validation steps.