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Endpoints for geroscience clinical trials: health outcomes, biomarkers, and biologic age

Steven R Cummings1,2, Stephen B Kritchevsky3

  • 1San Francisco Coordinating Center, California Pacific Medical Center Research Institute, San Francisco, CA, USA. steven.cummings@ucsf.edu.

Geroscience
|October 19, 2022
PubMed

Insights

Developing anti-aging treatments requires standardized clinical trial endpoints. Consensus on reliable biomarkers, like biological age, is crucial for efficiently testing interventions and validating their effectiveness in slowing aging processes.

Area of Science:

  • Gerontology
  • Biomedical Gerontology
  • Clinical Trial Design

Background:

  • Interventions targeting fundamental aging processes aim to delay multiple age-related diseases.
  • Clinical trials for anti-aging therapies need endpoints that accurately measure the benefits of slowing aging.

Purpose of the Study:

  • To highlight the need for consensus on clinical outcomes and surrogate biomarkers for geroscience trials.
  • To discuss the potential of biomarkers, such as biological age, to improve trial efficiency.

Main Methods:

  • Review of current approaches to endpoint selection in aging research.
  • Discussion on the requirements for validating surrogate biomarkers in clinical trials.

Main Results:

  • Standardized clinical outcomes are necessary for comparing geroscience trial results.
  • Biomarkers could reduce trial duration and size, but require rigorous validation.

Conclusions:

  • Consensus on clinical outcomes and validated surrogate biomarkers is essential for advancing anti-aging research.
  • Developing trusted surrogate outcomes will enable efficient testing of novel anti-aging treatments.
Keywords:
Biological ageClinical trialsEpigenetic ageGeroscienceSurrogate marker

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