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Related Experiment Videos

Does the Prentice criterion validate surrogate endpoints?

Vance W Berger1

  • 1Biometry Research Group, National Cancer Institute at University of Maryland Baltimore County, National National Institutes of Health, USA.vb78c@nih.gov

Statistics in Medicine
|May 4, 2004
PubMed
Summary
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Surrogate endpoints in clinical trials are popular but may not reflect true patient benefit. The Prentice criterion, used for validation, does not guarantee that surrogate endpoint improvements infer actual clinical outcome improvements.

Area of Science:

  • Clinical trial methodology
  • Biostatistics
  • Drug development

Background:

  • Clinical trials powered by survival endpoints are costly and time-consuming.
  • Surrogate endpoints (e.g., tumor response, PSA) are frequently used to expedite trials.
  • The validity of surrogate endpoints in reflecting true patient benefit is a critical concern.

Purpose of the Study:

  • To evaluate the conditions under which surrogate endpoints accurately predict clinical benefit.
  • To assess the implications of the Prentice criterion for surrogate endpoint validation.
  • To clarify the inferential power of surrogate endpoint improvements on true clinical endpoints.

Main Methods:

  • Analysis of the Prentice criterion for surrogate endpoint validation.
  • Theoretical examination of the relationship between treatment effects on surrogate and true clinical endpoints.

Related Experiment Videos

  • Review of clinical trial data illustrating the limitations of surrogate endpoints.

    • Main Results:

    • The Prentice criterion ensures that treatment effects on true endpoints imply effects on surrogate endpoints.
    • Contrary to common belief, the Prentice criterion alone does not ensure that surrogate endpoint improvements infer true clinical endpoint benefits.
    • An NIH trial demonstrated that correcting irregular heartbeats (surrogate) did not improve survival and increased mortality (true endpoint).

    Conclusions:

    • Surrogate endpoints must be carefully validated to ensure they genuinely reflect patient benefit.
    • The Prentice criterion is insufficient on its own to infer clinical benefit from surrogate endpoint improvements.
    • Over-reliance on surrogate endpoints without rigorous validation can lead to misleading conclusions and potential patient harm.