Clinical Outcomes Solutions, Tucson, AZ, USA.
Electronic Clinical Outcome Assessment (eCOA) Consortium, Critical Path Institute, Tucson, AZ, USA.
Value Health. 2023 Aug;26(8):1242-1248. doi: 10.1016/j.jval.2023.02.011. Epub 2023 Feb 26.
The electronic patient-reported outcome (ePRO) Dataset Structure and Standardization Project is a multistakeholder initiative formed by Critical Path Institute's PRO Consortium and Electronic Clinical Outcome Assessment (eCOA) Consortium to address issues related to ePRO dataset structure and standardization and to provide best practice recommendations for clinical trial sponsors and eCOA providers. Given the many benefits of utilizing electronic modes to capture PRO data, clinical trials are increasingly using these methods, yet there are challenges to using data generated by eCOA systems. Clinical Data Interchange Standards Consortium (CDISC) standards are used in clinical trials to ensure consistency in data collection, tabulation, and analysis and to facilitate regulatory submission. Currently, ePRO data are not required to follow a standard model, and the data models used often vary by eCOA provider and sponsor. This lack of consistency creates risks for programming and analysis and difficulties for analytics functions generating the required analysis and submission datasets. There is a disconnect between data standards used for study data submission and those used for data collection via case report forms and ePRO forms, which would be mitigated through the application of CDISC standards for ePRO data capture and transfer. The project was formed to collate and examine the issues arising from the lack of adoption of standardized approaches and this paper details recommendations to address those issues. Recommendations to address issues with ePRO dataset structure and standardization include adopting CDISC standards in the ePRO data platform, timely involvement of key stakeholders, ensuring ePRO controls are implemented, addressing issues of missing data early in development, ensuring quality control and validation of ePRO datasets, and use of read-only datasets.
电子患者报告结局 (ePRO) 数据集结构和标准化项目是由关键路径研究所的 PRO 联盟和电子临床结局评估 (eCOA) 联盟组成的多方利益相关者倡议，旨在解决与 ePRO 数据集结构和标准化相关的问题，并为临床试验赞助商和 eCOA 提供商提供最佳实践建议。鉴于利用电子模式采集 PRO 数据有许多好处，临床试验越来越多地使用这些方法，但在使用 eCOA 系统生成的数据时存在挑战。临床数据交换标准协会 (CDISC) 标准用于临床试验，以确保数据收集、制表和分析的一致性，并促进监管提交。目前，ePRO 数据不需要遵循标准模型，并且使用的数据模型通常因 eCOA 提供商和赞助商而异。这种不一致性为编程和分析带来了风险，并为生成所需分析和提交数据集的分析功能带来了困难。用于研究数据提交的数据标准与用于通过病例报告表和 ePRO 表单进行数据收集的数据标准之间存在脱节，如果通过应用 CDISC 标准进行 ePRO 数据采集和传输，这种脱节情况将会得到缓解。该项目的成立是为了整理和检查由于缺乏采用标准化方法而产生的问题，本文详细介绍了解决这些问题的建议。解决 ePRO 数据集结构和标准化问题的建议包括在 ePRO 数据平台中采用 CDISC 标准、及时让关键利益相关者参与、确保实施 ePRO 控制、在开发早期解决数据缺失问题、确保 ePRO 数据集的质量控制和验证、以及使用只读数据集。
