为虚弱老年人的肌肉减少症设计药物临床试验：欧盟/美国工作组的建议。
Designing pharmaceutical trials for sarcopenia in frail older adults: EU/US Task Force recommendations.
机构信息
University of Toulouse III, Toulouse, France.
出版信息
J Nutr Health Aging. 2013 Jul;17(7):612-8. doi: 10.1007/s12603-013-0362-7.
Abstract
An international task force of academic and industry leaders in sarcopenia research met on December 5, 2012 in Orlando, Florida to develop guidelines for designing and executing randomized clinical trials of sarcopenia treatments. The Task Force reviewed results from previous trials in related disease areas to extract lessons relevant to future sarcopenia trials, including practical issues regarding the design and conduct of trials in elderly populations, the definition of appropriate target populations, and the selection of screening tools, outcome measures, and biomarkers. They discussed regulatory issues, the challenges posed by trials of different types of interventions, and the need for standardization and harmonization. The Task Force concluded with recommendations for advancing the field toward better clinical trials.
摘要
2012 年 12 月 5 日，国际肌少症研究学术和产业界的专家组成的一个特别工作组在佛罗里达州的奥兰多开会，制定肌少症治疗的随机临床试验设计和实施指南。特别工作组回顾了相关疾病领域以往试验的结果，以提取对未来肌少症试验有借鉴意义的经验教训，包括老年人临床试验设计和实施的实际问题、合适目标人群的定义，以及筛选工具、结果指标和生物标志物的选择。他们讨论了监管问题、不同类型干预试验带来的挑战，以及标准化和协调的必要性。特别工作组最后就推动该领域更好地开展临床试验提出了建议。
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