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.
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