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J Gerontol A Biol Sci Med Sci. 2017 Mar 1;72(3):355-361. doi: 10.1093/gerona/glw220.

Clinical Trials Targeting Aging and Age-Related Multimorbidity.

Author information

1
Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.
2
Davis School of Gerontology, University of Southern California, Los Angeles.
3
Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.
4
Department of Medicine, Albert Einstein College of Medicine, Bronx, New York.
5
Department of Epidemiology and Biostatistics, University of Texas Health Science Center, San Antonio.
6
Laboratory of Epidemiology, Demography, and Biometry, National Institute on Aging, Bethesda, Maryland.
7
Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.
8
Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
9
University of Iowa Carver College of Medicine.
10
Division of Epidemiology, Department of Health Sciences Research and.
11
Department of Neurology, Mayo Clinic, Rochester, Minnesota.
12
The Biostatistics Center, The George Washington University, Rockville, Maryland.
13
Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis.
14
The Institute for Aging Research, Albert Einstein College of Medicine, Bronx, New York.

Abstract

Background:

There is growing interest in identifying interventions that may increase health span by targeting biological processes underlying aging. The design of efficient and rigorous clinical trials to assess these interventions requires careful consideration of eligibility criteria, outcomes, sample size, and monitoring plans.

Methods:

Experienced geriatrics researchers and clinical trialists collaborated to provide advice on clinical trial design.

Results:

Outcomes based on the accumulation and incidence of age-related chronic diseases are attractive for clinical trials targeting aging. Accumulation and incidence rates of multimorbidity outcomes were developed by selecting at-risk subsets of individuals from three large cohort studies of older individuals. These provide representative benchmark data for decisions on eligibility, duration, and assessment protocols. Monitoring rules should be sensitive to targeting aging-related, rather than disease-specific, outcomes.

Conclusions:

Clinical trials targeting aging are feasible, but require careful design consideration and monitoring rules.

KEYWORDS:

Chronic diseases; Clinical trial design; Geroscience

PMID:
28364543
PMCID:
PMC5777384
DOI:
10.1093/gerona/glw220
[Indexed for MEDLINE]
Free PMC Article

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