建立对现实世界证据 (RWE) 的信任:将RWE的透明度转向随机对照试验标准
1Oxford PharmaGenesis, Oxford, UK.
Current medical research and opinion
|October 3, 2023
概括
建立对现实世界证据 (RWE) 的信任需要更大的透明度. 新的工具和指导正在提高RWE研究的透明度,但需要进一步实施以符合随机对照试验 (RCT) 标准.
科学领域:
- 卫生经济学与研究成果研究成果
- 监管科学 监管科学
- 数据科学数据科学数据科学
背景情况:
- 现实世界证据 (RWE) 越来越多地用于监管和报销决策.
- 由于透明度的提高,人们对RWE的信任正在增长.
- 之前对RWE信任的障碍在2016年被确定.
研究的目的:
- 审查RWE透明度方面的进展.
- 确定新的RWE透明度指南和工具.
- 将RWE透明度倡议与随机对照试验 (RCT) 的倡议进行比较.
主要方法:
- 文献审查和在线来源的分析.
- 评估监管机构 (FDA,EMA) 和行业组织 (ISPOR-ISPE) 的举措.
- 对RWE方法,数据质量和报告的工具和框架的评估.
主要成果:
- 新的指导和工具 (例如,STaRT-RWE,HARPER,SPIFD2,REQueST) 提高了RWE研究方法,数据和报告的透明度.
- 像REPEAT和RWE DUPLICATE这样的倡议解决了RWE研究可重现性和有效推断.
- 在RWE研究战略和报告的透明度方面取得了进展.
结论:
- 通过新的工具和指导,在提高RWE透明度方面取得了重大进展.
- 进一步实施是必要的,以充分嵌入这些进展.
- 提高RWE透明度标准与RCT的标准相匹配是最终目标.
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