EVALUATING BIOLOGICAL HALLMARKS OF AGING IN A CLINICAL TRIAL ON AGING: OBSTACLES BETWEEN BENCH AND BEDSIDE

A wealth of research has highlighted the role of biological aging pathways, conceptualized as 9 hallmarks or 7 pillars, in longevity as well as varied pathologies and functional deficits of aging. A biomarker component designed to support the conceptualization, design and implementation of a geroscience-guided clinical trial such as TAME, should ideally utilize biomarkers as: 1. indicators of the intervention’s (metformin) biological effect; 2. proxy measures of clinical outcomes; 3. measures of the intervention’s impact upon specific biological pathways of aging. A systematic review of the literature revealed a paucity of routinely available tools to allow the systematic assessment of individual biological pathways in subjects participating in a multisite clinical trial. We will discuss strategies for addressing these challenges using a multilayered approach involving the selection of a panel of biomarkers to be measured in all trial participants, accompanied by smaller proof of concept studies involving biological measurements ancillary studies