Frameworks for Proof-of-Concept Clinical Trials of Interventions That Target Fundamental Aging Processes

This article summarizes the outcomes of an international meeting partly funded through the NIH R24 Geroscience Network, whose purpose was to generate concepts and frameworks for early, proof-of-concept clinical trials for therapeutic interventions that target fundamental processes of aging. The goals of proof-of-concept trials include generating preliminary signals of efficacy in an aging-related disease or outcome that will reduce the risk of conducting larger trials, contributing data and biological samples to support larger-scale research by strategic networks, and furthering a dialogue with regulatory agencies on appropriate registration indications. We describe three frameworks for proof-of-concept trials that target age-related chronic diseases, geriatric syndromes, or resilience to stressors. We propose strategic infrastructure and shared resources that could accelerate development of therapies that target fundamental aging processes.

Source: Journals of Gerontology Series A: Biological Sciences and Medical Sciences - October 7, 2016 Category: Geriatrics Authors: Justice, J., Miller, J. D., Newman, J. C., Hashmi, S. K., Halter, J., Austad, S. N., Barzilai, N., Kirkland, J. L. Tags: Special Issue: Moving Geroscience Into Uncharted Waters: Perspective Source Type: research