title: Frameworks for Proof-of-Concept Clinical Trials of Interventions That Target Fundamental Aging Processes.
abstract: Therapies targeted at fundamental processes of aging may hold great promise for enhancing the health of a wide population by delaying or preventing a range of age-related diseases and conditions-a concept dubbed the "geroscience hypothesis." Early, proof-of-concept clinical trials will be a key step in the translation of therapies emerging from model organism and preclinical studies into clinical practice. 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.
authors.affiliation: Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston Salem, North Carolina.
authors.forename: Jamie
authors.initials: J
authors.lastname: Justice
authors.affiliation: Department of Surgery.|Department of Physiology and Biomedical Engineering and.|The Robert and Arlene Kogod Center on Aging, Mayo Clinic, Rochester, Minnesota.
authors.forename: Jordan D
authors.initials: JD
authors.lastname: Miller
authors.affiliation: Division of Geriatrics, University of California San Francisco.
authors.forename: John C
authors.initials: JC
authors.lastname: Newman
authors.affiliation: Department of Hematology and Transplant Center, Mayo Clinic, Rochester, Minnesota.
authors.forename: Shahrukh K
authors.initials: SK
authors.lastname: Hashmi
authors.affiliation: Geriatrics Center and Institute of Gerontology, University of Michigan, Ann Arbor.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Halter
authors.affiliation: Department of Biology, University of Alabama at Birmingham.
authors.forename: Steve N
authors.initials: SN
authors.lastname: Austad
authors.affiliation: Department of Medicine, Division of Endocrinology and.|Institute for Aging Research, Albert Einstein College of Medicine, New York.
authors.forename: Nir
authors.initials: N
authors.lastname: Barzilai
authors.affiliation: Department of Physiology and Biomedical Engineering and kirkland.james@mayo.edu.|The Robert and Arlene Kogod Center on Aging, Mayo Clinic, Rochester, Minnesota.
authors.forename: James L
authors.initials: JL
authors.lastname: Kirkland
mesh_terms: D000368:Aged; D000375:Aging / Q000473:pathology*; D000818:Animals; D015415:Biomarkers / Q000032:analysis; D035843:Biomedical Research; D002908:Chronic Disease; D002986:Clinical Trials as Topic; D003226:Congresses as Topic; D004195:Disease Models, Animal; D018450:Disease Progression; D006801:Humans; D008136:Longevity; D012107:Research Design
chemical_list: D015415:Biomarkers
keywords: Aging; Clinical trials; Geroscience Network