TY - JOUR
T1 - Clinical trials targeting aging and age-related multimorbidity
AU - Espeland, Mark A.
AU - Crimmins, Eileen M.
AU - Grossardt, Brandon R.
AU - Crandall, Jill P.
AU - Gelfond, Jonathan A.L.
AU - Harris, Tamara B.
AU - Kritchevsky, Stephen B.
AU - Manson, Joann E.
AU - Robinson, Jennifer G.
AU - Rocca, Walter A.
AU - Temprosa, Marinella
AU - Thomas, Fridtjof
AU - Wallace, Robert
AU - Barzilai, Nir
N1 - Funding Information:
The Health and Retirement Study was funded by the National Institute on Aging (NIA; U01 AG09740). The Rochester Epidemiology Project infrastructure is funded by the National Institutes of Health (R01AR030582 and R01AG034676; PI: W.A.R., MD, MPH). The Women's Health Initiative was funded by the National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services. The American Federation for Aging Research has provided support for this work (J.P.C. and N.B.). Additional support has been provided by the Nathan Shock Center of Excellence for the Biology of Aging (P30AG038072, N.B.), the Glenn Center for the Biology of Human Aging (Paul Glenn Foundation for Medical Research) (N.B.), grant 1R24AG044396 from the NIA (PI: Kirkland; co-PI: N.B.), grant P30 AG021332 from the NIA to the Wake Forest Older Americans Independence Center (S.B.K.), and HHS contract HHSN26801100004C (PI: Shumaker; co-PI: M.A.E).
Publisher Copyright:
© The Author 2016.
PY - 2017
Y1 - 2017
N2 - 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.
AB - 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.
KW - Chronic diseases
KW - Clinical trial design
KW - Geroscience
UR - http://www.scopus.com/inward/record.url?scp=85016185737&partnerID=8YFLogxK
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U2 - 10.1093/gerona/glw220
DO - 10.1093/gerona/glw220
M3 - Article
C2 - 28364543
AN - SCOPUS:85016185737
SN - 1079-5006
VL - 72
SP - 355
EP - 361
JO - Journals of Gerontology - Series A Biological Sciences and Medical Sciences
JF - Journals of Gerontology - Series A Biological Sciences and Medical Sciences
IS - 3
ER -