Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.
Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China
BMJ Open. 2022 Aug 3;12(8):e059029. doi: 10.1136/bmjopen-2021-059029.
To investigate the existing barriers and recommendations of real-world data (RWD) standardisation for clinical research through a qualitative study on different stakeholders.
This qualitative study involved five types of stakeholders based on five interview outlines. The data analysis was performed using the constructivist grounded theory analysis process.
Eight hospitals, four hospital system vendors, three big data companies, six medical products companies and four regulatory institutions were included.
In total, 62 participants from 25 institutions were interviewed through purposive sampling.
The findings showed that the lack of clinical applicability in existing terminology standards, lack of generalisability in existing research databases, and lack of transparency in existing data standardisation process were the barriers of data standardisation of RWD for clinical research. Enhancing terminology standards by incorporating locally used clinical terminology, reducing burden in the usage of terminology standards, improving generalisability of RWD for research by using clinical data models, and improving traceability to source data for transparency might be feasible suggestions for solving the current problems.
Efficient and reliable data standardisation of RWD for clinical research can help generate better evidence used to support regulatory evaluation of medical products. This research suggested enhancing terminology standards by incorporating locally used clinical terminology, reducing burden in the usage of terminology standards, improving generalisability of RWD for research by using clinical data models, and improving traceability to source data for transparency to guide efforts in data standardisation in the future.
通过对不同利益相关者的定性研究，探讨真实世界数据（RWD）标准化在临床研究中存在的障碍和建议。
本定性研究基于五个访谈大纲，涉及五类利益相关者。采用建构主义扎根理论分析流程进行数据分析。
纳入了 8 家医院、4 家医院系统供应商、3 家大数据公司、6 家医疗产品公司和 4 家监管机构。
通过目的性抽样，共有来自 25 家机构的 62 名参与者接受了访谈。
研究结果表明，现有术语标准缺乏临床适用性、现有研究数据库缺乏通用性以及现有数据标准化过程缺乏透明度，这些都是 RWD 标准化用于临床研究的障碍。通过纳入本地使用的临床术语来增强术语标准、减少术语标准使用的负担、通过使用临床数据模型提高 RWD 研究的通用性以及提高透明度以追溯源数据，这些可能是解决当前问题的可行建议。
RWD 用于临床研究的数据标准化的效率和可靠性有助于生成更好的证据，用于支持对医疗产品的监管评估。本研究建议通过纳入本地使用的临床术语来增强术语标准、减少术语标准使用的负担、通过使用临床数据模型提高 RWD 研究的通用性以及提高透明度以追溯源数据，以指导未来的数据标准化工作。
