Espeland Mark A, Crimmins Eileen M, Grossardt Brandon R, Crandall Jill P, Gelfond Jonathan A L, Harris Tamara B, Kritchevsky Stephen B, Manson JoAnn E, Robinson Jennifer G, Rocca Walter A, Temprosa Marinella, Thomas Fridtjof, Wallace Robert, Barzilai Nir
Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.
Davis School of Gerontology, University of Southern California, Los Angeles.
J Gerontol A Biol Sci Med Sci. 2017 Mar 1;72(3):355-361. doi: 10.1093/gerona/glw220.
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.
人们越来越关注通过针对衰老背后的生物学过程来确定可能延长健康寿命的干预措施。设计高效且严谨的临床试验来评估这些干预措施需要仔细考虑纳入标准、结局指标、样本量和监测计划。
经验丰富的老年医学研究人员和临床试验专家合作，为临床试验设计提供建议。
基于与年龄相关的慢性疾病的累积和发病率的结局指标，对于针对衰老的临床试验具有吸引力。通过从三项针对老年人的大型队列研究中选择有风险的个体亚组，制定了多种疾病结局的累积和发病率。这些为关于纳入标准、持续时间和评估方案的决策提供了具有代表性的基准数据。监测规则应针对与衰老相关而非特定疾病的结局指标保持敏感。
针对衰老的临床试验是可行的，但需要仔细的设计考量和监测规则。
