Nature Communications · 13 authors, 35 centres
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This narrative review discusses the methodological and regulatory challenges in designing clinical trials for Geroscience, which aims to target fundamental aging processes to prevent multiple age-related diseases. It highlights the need for new trial outcomes and regulatory frameworks, using the approved TAME trial as a key example.
This narrative review outlines the challenges in developing Geroscience clinical trials. The authors explain that Geroscience aims to target fundamental aging processes to improve healthspan and reduce multiple age-related diseases. A central challenge is defining approvable indications for regulatory agencies like the FDA and EMA, as aging itself is not considered a disease. The review discusses potential trial outcomes, including composite scores for disease incidence, geriatric syndromes, and physical function, and cautions about their limitations. It cites the FDA-approved TAME trial, which targets a composite of age-related diseases and mortality, as a potential proof of concept for regulatory acceptance. The review also mentions other trial examples, such as a study on mesenchymal stem cells for frailty, to illustrate outcome heterogeneity.
