Clinical Endpoint

Definition

A clinical endpoint is an outcome measured in a study or clinical trial that directly reflects how a person feels, functions, or survives. Examples include death, disease diagnosis, hospitalisation, disability, symptoms, physical function, or other outcomes that represent meaningful clinical benefit or harm. [1] [2]

Why It Matters in Ageing Research

Clinical endpoints matter because ageing research ultimately needs to show improvements in outcomes that are meaningful for people, not only changes in biomarkers or biological pathways. In longevity studies, clinical endpoints may include delayed onset of age-related disease, reduced disability, preserved mobility, lower frailty, improved quality of life, or reduced mortality. [1] [3] [4]

Common Confusion

• A clinical endpoint is not the same as a biomarker; it measures a health outcome more directly.
• Clinical endpoints can be objective, such as mortality, or patient-centred, such as symptoms or function.
• Improving a biomarker does not always mean improving a clinical endpoint.

Related Reading

• Surrogate Endpoint
• Composite Endpoint

References

1. FDA-NIH Biomarker Working Group. (2016). BEST (Biomarkers, EndpointS, and other Tools) Resource. https://www.ncbi.nlm.nih.gov/books/NBK338448/
2. U.S. Food and Drug Administration. (2018). Clinical Outcome Assessment Compendium. https://www.fda.gov/drugs/development-resources/clinical-outcome-assessment-compendium
3. Justice, J. N., Ferrucci, L., Newman, A. B., Aroda, V. R., Bahnson, J. L., Divers, J., Espeland, M. A., Marcovina, S., Pollak, M. N., Kritchevsky, S. B., & Barzilai, N. (2018). A framework for selection of blood-based biomarkers for geroscience-guided clinical trials: Report from the TAME Biomarkers Workgroup. https://doi.org/10.1007/s11357-018-0042-y
4. Moqri, M., Herzog, C., Poganik, J. R., et al. (2023). Biomarkers of aging for the identification and evaluation of longevity interventions. https://doi.org/10.1016/j.cell.2023.08.003