喷泉:一个模块化研究平台,用于整合真实世界的证据生成
Nikolaus G Oberprieler1, Manel Pladevall-Vila2,3, Catherine Johannes4
1Bayer AS, Oslo, Norway. niki.oberprieler@bayer.com.
BMC medical research methodology
|October 1, 2024
概括
喷泉平台协调了现实世界的证据 (RWE) 生产,用于更精细的研究. 这种方法提高了RWE的一致性和通用性,改善了临床决策.
科学领域:
- 药学流行病学 药学流行病学
- 健康 数据科学 数据科学
- 临床研究信息学 临床研究信息学
背景情况:
- 现实世界的证据 (RWE) 对于监管和医疗保健决策至关重要.
- 分碎的RWE可能会由于异质性和缺乏可重复性而限制临床效用.
- 跨数据源的方法的协调对于提高RWE质量至关重要.
研究的目的:
- 描述多学科的FOUNTAIN研究平台 (FinerenOne多数据库网络用于生成证据AtIoN).
- 探索协调RWE发电的优势和局限性.
- 提供关于finerenone的现实世界利用,有效性和安全性的见解.
主要方法:
- 建立了一个多学科研究平台 (FOUNTAIN) 提供专家指导.
- 整合了各种RWE生成方法,包括合作和共同数据模型 (CDM).
- 确保医学定义,方法和可重复的文物在研究中的协调.
主要成果:
- 喷泉平台包括9个研究合作伙伴协作和8个CDM映射数据源在7个国家.
- 目前正在进行6项多国,多数据库的队列研究.
- 目前正在进行的研究重点是患者群体,护理标准,并发症,医疗资源使用以及finerenone的有效性和安全性.
结论:
- 喷泉平台可以协调执行多项研究,提高一致性.
- 它促进了使用多个数据源和所有平台研究的研究中的一致性.
- 喷泉提供了一种策略,以提高RWE的一致性和通用性.
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