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J Gerontol A Biol Sci Med Sci. 2016 Nov;71(11):1415-1423. Epub 2016 Aug 16.

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

Author information

1
Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston Salem, North Carolina.
2
Department of Surgery.
3
Department of Physiology and Biomedical Engineering and.
4
The Robert and Arlene Kogod Center on Aging, Mayo Clinic, Rochester, Minnesota.
5
Division of Geriatrics, University of California San Francisco.
6
Department of Hematology and Transplant Center, Mayo Clinic, Rochester, Minnesota.
7
Geriatrics Center and Institute of Gerontology, University of Michigan, Ann Arbor.
8
Department of Biology, University of Alabama at Birmingham.
9
Department of Medicine, Division of Endocrinology and.
10
Institute for Aging Research, Albert Einstein College of Medicine, New York.
11
Department of Physiology and Biomedical Engineering and kirkland.james@mayo.edu.

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.

KEYWORDS:

Aging; Clinical trials; Geroscience Network

PMID:
27535966
PMCID:
PMC5055651
DOI:
10.1093/gerona/glw126
[Indexed for MEDLINE]
Free PMC Article

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