title: Clinical Trials Targeting Aging and Age-Related Multimorbidity.
abstract: 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.
  
  
  
  Experienced geriatrics researchers and clinical trialists collaborated to provide advice on clinical trial design.
  
  
  
  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.
  
  
  
  Clinical trials targeting aging are feasible, but require careful design consideration and monitoring rules.
authors.affiliation: Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Espeland
authors.affiliation: Davis School of Gerontology, University of Southern California, Los Angeles.
authors.forename: Eileen M
authors.initials: EM
authors.lastname: Crimmins
authors.affiliation: Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.
authors.forename: Brandon R
authors.initials: BR
authors.lastname: Grossardt
authors.affiliation: Department of Medicine, Albert Einstein College of Medicine, Bronx, New York.
authors.forename: Jill P
authors.initials: JP
authors.lastname: Crandall
authors.affiliation: Department of Epidemiology and Biostatistics, University of Texas Health Science Center, San Antonio.
authors.forename: Jonathan A L
authors.initials: JA
authors.lastname: Gelfond
authors.affiliation: Laboratory of Epidemiology, Demography, and Biometry, National Institute on Aging, Bethesda, Maryland.
authors.forename: Tamara B
authors.initials: TB
authors.lastname: Harris
authors.affiliation: Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Kritchevsky
authors.affiliation: Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: JoAnn E
authors.initials: JE
authors.lastname: Manson
authors.affiliation: University of Iowa Carver College of Medicine.
authors.forename: Jennifer G
authors.initials: JG
authors.lastname: Robinson
authors.affiliation: Division of Epidemiology, Department of Health Sciences Research and.|Department of Neurology, Mayo Clinic, Rochester, Minnesota.
authors.forename: Walter A
authors.initials: WA
authors.lastname: Rocca
authors.affiliation: The Biostatistics Center, The George Washington University, Rockville, Maryland.
authors.forename: Marinella
authors.initials: M
authors.lastname: Temprosa
authors.affiliation: Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis.
authors.forename: Fridtjof
authors.initials: F
authors.lastname: Thomas
authors.affiliation: University of Iowa Carver College of Medicine.
authors.forename: Robert
authors.initials: R
authors.lastname: Wallace
authors.affiliation: The Institute for Aging Research, Albert Einstein College of Medicine, Bronx, New York.
authors.forename: Nir
authors.initials: N
authors.lastname: Barzilai
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000375:Aging; D002908:Chronic Disease / Q000453:epidemiology*; D002986:Clinical Trials as Topic; D015897:Comorbidity; D018450:Disease Progression; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male
keywords: Chronic diseases; Clinical trial design; Geroscience