Key result
HMA-EMA taskforce outlines core recommendations for integrating big data into European regulatory decision-making.
Provides a summary of regulatory frameworks and CDISC data standards for in silico and in vivo medical device trials, particularly for TAVI.
May guide EU regulators on big data standards for TAVI trials; leaves open prospective validation of impact on decisions.
This report summarizes the current applicable regulatory framework and CDISC data standards for in vivo and in silico medical device randomized clinical trials, with an emphasis on transcatheter aortic valve replacement devices (TAVI). Trial Implementation issues and scenarios are discussed as well. This report has been prepared within the Horizon 2020 programme ‘In-Silico testing and validation of Cardiovascular IMplantable devices‘ (SIMCOR, GAID: 101017578) project and would be of relevance for clinical development, data management, and regulatory submission teams.
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Aydın et al. (2023) studied Big Data in Regulatory Decision Making. The HMA-EMA Joint Big Data Taskforce report outlines core recommendations for data standardisation, quality, sharing, and analytics to integrate big data into European regulatory decision-making.
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