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在药物开发中纳入肥胖者:当前状态和机会

Jayabharathi Vaidyanathan¹, Elimika Pfuma Fletcher¹, Anuradha Ramamoorthy¹

¹Office of Clinical Pharmacology, Office of Translational Sciences, Center of Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Journal of clinical pharmacology

|November 9, 2023

概括

肥胖患病率正在上升,但临床试验缺乏多样化的代表性,导致肥胖患者药物剂量信息不足. 目前正在进行监管工作,以改善试验多样性并解决这些关键的知识差距.

科学领域:

药理学和临床试验设计.
肥胖和并发症研究研究

背景情况:

全球肥胖率的上升增加了疾病并发症的风险,需要量身定制的治疗干预措施和精确的剂量指南.
目前的药物开发计划往往排除肥胖个体,导致对治疗反应的理解不足和个性化药物选择有限.
对已批准的药物标签的调查显示,对于成人和儿科患者,显著缺乏针对肥胖症的剂量信息.

研究的目的:

突出在临床试验中改善肥胖个体代表性的关键需求.
在药物开发中确定代表性不足和缺乏以肥胖为重点的剂量指南的原因.
讨论旨在增强肥胖人口临床试验多样性的最近的监管举措.

主要方法:

分析现有的药物产品包装插件,以获取与肥胖相关的剂量信息.
审查临床试验招生实践及其对患者多样性的影响.
审查最近的监管指导和利益相关者参与战略.

主要成果:

很少有批准的药物产品为肥胖个体提供具体的剂量建议.
报告不足和缺乏临床试验多样性,包括排除患有并发病的患者,有助于这一数据缺口.
监管机构正在积极促进多样性,并为肥胖人口的药物开发提供指导.

结论:

解决临床试验中缺乏多元化代表性的问题对于了解肥胖患者的药物疗效和安全至关重要.
加强临床试验多样性和遵守新的监管指南将改善肥胖患者药物剂量个性化.
这些举措对于弥合知识差距和确保对日益增长的肥胖人口提供适当的治疗至关重要.

关键词:

美国食品和药物管理局 (FDA) 的指导方针.临床药理学临床药理学临床试验多样性临床试验多样性剂量剂量剂量剂量剂量肥胖肥胖肥胖肥胖肥胖肥胖肥胖肥胖

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