# Selecting Appropriate Clinical Trial Endpoints for Geroscience Trials: A Path Towards Consensus

**Authors:** Stephen Kritchevsky, Ezequiel Zamora, Shalender Bhasin, Alan Cohen, Allison Chandler, Kevin Covinsky, Heidi Crane, Steven Cummings, Kristine Erlandson, Mark Espeland, Sara Espinoza, Luigi Ferrucci, Alexander Fleming, Daniel Forman, Michael LaCroix-Fralish, Mitzi Gonzales, Jamie Justice, Douglas Kiel, George Kuchel, Joan Mannick, Joseph Menetski, Michael Miller, Nicolas Musi, Anne Newman, John Newman, Sarah Simpson Owens, Ambarish Pandey, Kandice Reilly, Mina Sedrak, John Wagner, Heather Whitson, Jeff Williamson

PMC · DOI: 10.21203/rs.3.rs-5920485/v1 · Research Square · 2025-02-12

## TL;DR

Experts agree on using multiple health measures for clinical trials targeting age-related conditions, focusing on patient goals and function.

## Contribution

The study identifies consensus on clinical endpoints for geroscience trials using a modified Delphi process with 28 experts.

## Key findings

- Experts agreed that outcome measures should include multiple health dimensions like age-related disease and function.
- Blood-based biomarkers were deemed unlikely to be accepted as primary endpoints in efficacy trials.
- Plausible composite endpoints included mortality, mobility function, and onset of multiple age-related diseases.

## Abstract

Using a modified Delphi process, we engaged 28 experts in clinical trials, geriatrics, and research translation to determine if there were consensus around what clinical endpoints should be used for trials evaluating the efficacy of interventions to prevent or treat multiple age-related conditions. Four focus groups developed themes. Statements related to those themes were circulated back to participants in a survey. There was consensus (more than 66% agreed or disagreed) that outcome measures should include multiple health dimensions including-age-related disease, function and patient reported outcomes that reflect participants goals; and be tailored to population characteristics. Experts felt that blood-based biomarkers would be unlikely to be accepted as primary endpoints of efficacy trials. Plausible components mentioned as part of a composite endpoint included mortality, mobility function and the onset of multiple age-related diseases. Our findings provide guidance on acceptable approaches to endpoint selection guiding the design of future geroscience trials.

## Full-text entities

- **Diseases:** age-related (MESH:D010024), age-related conditions (MESH:D008569)
- **Species:** Homo sapiens (human, species) [taxon 9606]

## Full text

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## Figures

5 figures with captions in the complete paper: https://tomesphere.com/paper/PMC11844647/full.md

## References

21 references — full list in the complete paper: https://tomesphere.com/paper/PMC11844647/full.md

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Source: https://tomesphere.com/paper/PMC11844647