患者报告的结果在第三阶段临床试验中得到验证:针对性的文献综述
Antonia Morga1, Silvia Dibenedetto2, Rocco Adiutori2
1Astellas Pharma Europe Ltd, Addlestone, UK.
Current medical research and opinion
|June 20, 2023
概括
在第三阶段临床试验中验证的患者报告结果 (PRO) 仪器可以支持监管标签要求. 这次审查发现,验证的PRO,无论是新型还是现有,都成功地为药物批准产生了以患者为中心的证据.
科学领域:
- 临床试验设计 临床试验设计
- 患者报告的结果
- 监管科学 监管科学
背景情况:
- 监管指南强调在关键临床研究中使用患者报告结果 (PRO) 仪器之前对其进行验证.
- 经过验证的PRO仪器对于产生以患者为中心的证据和支持药物标签要求至关重要.
- 本综述特别审查了在第三阶段试验中验证的PRO仪器,以评估它们在支持同一研究中的标签声明中的有用性.
研究的目的:
- 为了确定在第三阶段试验中经过心理测量验证的患者报告结果 (PRO) 仪器是否可以支持标签声明.
- 评估在第三阶段研究中使用验证的PRO生成关键的以患者为中心的证据的可行性.
主要方法:
- 在MEDLINE (2006-2021) 的有针对性的文献搜索中,确定了在第三阶段试验中验证的PRO工具.
- 搜索包括PRO仪器和验证属性的术语,没有治疗指示过.
- PROLABELS数据库交叉引用了在第三阶段试验中验证的PROs与已接受的标签声明.
主要成果:
- 选择了68项涉及78个PRO仪器的研究 (20项新型,58项现有) 在第三阶段试验中得到验证.
- 关键验证的心理测量属性包括可靠性,有效性,响应性和最小重要的差异.
- 五种新型仪器实现了七种药物的十个标签声明,证明了成功的应用.
结论:
- 在第三阶段试验中,可以成功地进行PRO仪器的定量验证,无论是新型还是现有的新适应症.
- 在第三阶段研究中作为终点使用的验证的PRO仪器可以有效地支持监管标签要求.
- 这支持使用PROs在药物开发中产生强有力的以患者为中心的证据.
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