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A Case for Synthetic Data in Regulatory Decision‐Making in Europe by Clara Alloza; Bethany Knox; Hanaya Raad; Mireia Aguilà; Ciara Coakley; Zuzana Mohrova; Élodie Boin; Marc Bénard; Jessica Davies; Emmanuelle Jacquot; Coralie Lecomte; Alban Fabre; Michael Batech is a Medicine article available to read on EtoBox.

What is A Case for Synthetic Data in Regulatory Decision‐Making in Europe about?

Regulators are faced with many challenges surrounding health data usage, including privacy, fragmentation, validity, and generalizability, especially in the European Union (EU), for which synthetic data may provide innovative solutions. Synthetic data, defined as data artificially generated rather than captured in the real world, are increasingly being used for healthcare research purposes as a proxy to real‐world data (RWD). Currently, there are barriers particularly challenging in Europe, where sharing patient's data is strictly regulated, costly, and time consuming, causing delays in evidence generation and regulatory approvals. Recent initiatives are encouraging the use of synthetic data in regulatory decision‐making and health technology assessment to overcome these challenges, but synthetic data have still to overcome realistic obstacles before their adoption by researchers and regulators in Europe. Thus, the emerging use of RWD and synthetic data by pharmaceutical and medical device industries calls regulatory bodies to provide a framework for proper evidence generation and informed regulatory decision‐making. As the provision of data becomes more ubiquitous in scientific re

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Author

Clara Alloza; Bethany Knox; Hanaya Raad; Mireia Aguilà; Ciara Coakley; Zuzana Mohrova; Élodie Boin; Marc Bénard; Jessica Davies; Emmanuelle Jacquot; Coralie Lecomte; Alban Fabre; Michael Batech

Publisher

Wiley

Published

2023

Language

EN

Field

Medicine (Health Sciences)