一项混合方法研究,以探索相关指标,用于测量基于依赖途径对公共卫生影响的结果框架
Inez Adams1, Patricia A Cuff2, Lawrence Liberti3
1Health and Medicine Division, National Academies of Sciences, Engineering, and Medicine, 500 Fifth St., NW, Washington, DC, 20001, USA.
基于依赖的监管途径加快了全球的医药接入. 衡量它们对公共卫生影响的关键指标包括满足时间表,获取专业知识和减少上市时间,最终降低发病率和死亡率.
科学领域:
- 监管科学 监管科学
- 公共卫生政策 公共卫生政策
- 制药政策 制药政策
背景情况:
- 基于依赖的途径对于全球及时获得安全有效的药物至关重要.
- 关于有效衡量这些监管途径对公共卫生的影响,研究有限.
- 需要一个强大的框架来评估依赖途径的好处和有效性.
研究的目的:
- 探索和确定衡量依赖性监管途径对公共卫生影响的关键指标.
- 制定一个框架来评估这些途径在推动全球健康方面取得的成功.
主要方法:
- 一个混合方法研究,结合了定量调查 (n=70) 和深入访谈 (n=10) 与各种利益相关者.
- 利益相关者包括行业,监管机构和非政府组织的代表.
- 数据收集的重点是确定公共卫生影响框架的重要指标.
主要成果:
- 调查受访者确定的前五个指标是:满足目标评估时间表,加强对专业知识的访问,减少中位数上市时间,降低发病率和死亡率,以及技术标准协调方面的进展.
- 深度访谈表明,这些指标的相关性可能根据区域或特定监管机构的背景而有所不同.
- 利益相关者普遍认为依赖途径有利,但强调需要在监管生态系统内进行协调.
结论:
- 基于依赖的途径是改善全球药物获取和公共卫生结果的宝贵工具.
- 包含关键指标的标准化框架对于评估其影响至关重要.
- 协调和明确理解成功因素对于最佳利用依赖路径至关重要.
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