英国药品和医疗器械联合数据网络的监管视角:来自"研究-a-thon"的经验教训
Helen P Booth1, John Connelly2, Daniel Dedman2
1Medicines and Healthcare products Regulatory Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU, UK. helen.booth@mhra.gov.uk.
Therapeutic innovation & regulatory science
|August 20, 2025
概括
英国的分布式数据网络可以使用现实数据 (RWD) 改善监管决策. 一项研究强调需要更好地获取数据和共同模型,以便及时生成现实世界的证据 (RWE).
科学领域:
- 医疗信息学
- 监管科学
- 数据科学
背景情况:
- 国际医疗监管机构的目标是通过真实世界数据 (RWD) 加强决策.
- 英国国家卫生服务局拥有大量人口数据,但在数据隔离,互操作性和交叉设置方面面临挑战.
- 动员英国分布式数据网络对于及时生成用于监管的真实世界证据至关重要.
研究的目的:
- 为监管目的探索英国分布式数据网络的潜力.
- 通过案例研究解决医疗器械和二次护理处方方面的高优先级数据缺口.
- 为英国药品和医疗保健产品监管局 (MHRA),利益相关方和国际合作伙伴确定关于RWD战略的关键经验.
主要方法:
- 在2023年召开了一个"Study-A-Thon"活动.
- 两个案例研究集中在医疗器械和二次护理处方数据缺口上.
- 分析数据缺陷以及当地数据和临床专业知识的重要性.
主要成果:
- 这项研究成功地产生了两项案例研究的结果,证明了该方法的可行性.
- 确定的缺陷包括缺乏跨护理机构的患者随访,以及需要共同的产品利用数据模型.
- 强调当地数据和临床专业知识在数据收集和解释中的关键作用.
结论:
- 随着进一步发展,英国的联合数据模型可以在整个产品生命周期内显著提高国家监管决策.
- 改善在护理地点的数据收集和可靠的解释对于成功生成RWE至关重要.
- 合作和应对数据基础设施挑战是利用RWD为监管目的的关键.
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