优化临床试验的设计,以评估功能促进疗法的有效性
Shalender Bhasin1, Peggy M Cawthon2, Rosaly Correa-de-Araujo3
1Research Program in Men's Health, Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
概括
开发用于衰老和慢性疾病的功能促进疗法需要优化试验设计. 合作是推动这些治疗和改善身体功能的关键.
科学领域:
- 老年学和制药研究研究.
- 临床试验设计和监管科学
背景情况:
- 候选分子用于治疗衰老和慢性疾病中的身体限制正在开发中.
- 障碍包括指示框架,资格标准,终点以及功能促进疗法的监管指导缺乏的挑战.
研究的目的:
- 讨论对促进功能治疗的临床试验设计的优化.
- 解决与衰老和慢性疾病相关的身体局限性治疗方法开发方面的挑战.
主要方法:
- 来自学术界,制药行业,国家卫生研究院 (NIH) 和食品和药物管理局 (FDA) 的专家们召开了会议.
- 讨论的重点是优化试验设计,包括指示,资格标准和终点.
主要成果:
- 由于其患病率和可靠的确诊,移动障碍是一个合适的指示.
- 准确的生物标志物 (例如,D3肌酸稀释) 和基于表现的/患者报告的措施至关重要.
- 多元组件功能训练可能是必要的,以将药物诱导的肌肉增长转化为功能改善.
结论:
- 功能促进剂的精心设计的试验需要学术研究人员,NIH,FDA,工业界,患者和专业社会之间的合作.
- 药理学药剂与多组分功能训练的整合显示出有希望.
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