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

Area of Science:

• Gerontology and Geriatric Medicine
• Clinical Trial Design
• Translational Research

Background:

• Designing effective clinical trials for geroscience requires consensus on appropriate outcome measures.
• Current endpoints may not adequately capture the multifaceted nature of aging and age-related conditions.

Purpose of the Study:

• To achieve expert consensus on clinical endpoint selection for trials targeting prevention or treatment of multiple age-related conditions.
• To guide the development of future geroscience research.

Main Methods:

• A modified Delphi process involving 28 experts in clinical trials, geriatrics, and research translation.
• Utilized focus groups to develop themes, followed by a participant survey for consensus building.

Main Results:

• Consensus reached that outcome measures must include multiple health dimensions: age-related disease, function, and patient-reported outcomes reflecting participant goals.
• Endpoints should be tailored to specific population characteristics.
• Blood-based biomarkers are unlikely to be accepted as primary efficacy endpoints.
• Plausible composite endpoint components include mortality, mobility function, and onset of multiple age-related diseases.

Conclusions:

• Established expert agreement on essential components for clinical trial endpoints in geroscience.
• Findings provide crucial guidance for designing future trials focused on aging and multiple comorbidities.