Development of Clinical Trials to Extend Healthy Lifespan.
Level 5 - mechanism / opinion, no new human data
Narrative review and trial design framework without empirical data
PubMed 30906924 · doi:10.1097/XCE.0000000000000159
What was done
This review outlines the conceptual framework, rationale, and consensus-building processes involved in designing large-scale clinical trials aimed at delaying multiple age-related chronic diseases simultaneously by targeting the biology of aging. It examines the design of the Targeting Aging with Metformin (TAME) trial as a representative case study and discusses methods for selecting molecular and biochemical markers of biological aging.
What was found
The abstract reports no empirical findings or numerical data. It describes the trial architecture and methodological framework for the TAME trial and future geroscience-guided clinical trials.
Why it matters
It establishes a methodological blueprint for translating fundamental biology-of-aging discoveries into multi-outcome clinical trials in humans.
Limits
The paper is a narrative overview and methodology paper containing no clinical trial results or empirical human data. The feasibility, efficacy, and regulatory endpoints described remain to be validated in completed randomized controlled trials.
Cited by
- supports Nir Barzilai and colleagues are engaged in discussions with the FDA regarding advancing metformin as an anti-aging therapeutic candidate.