Pharmaceutical industry stakeholders from both sides of the Atlantic generally supported the International Council for Harmonization’s (ICH) M14 guidance on using real world data (RWD) for pharmacoepidemiological studies, but suggested areas for improvement, such as adding more examples of how these principles will work in practice, addressing the use of artificial intelligence and machine learning (AI/ML), and expanding its scope to include combination products.
Groups said the guideline should address some of the drawbacks of using federated data networks (FDNs) for collecting RWD in their comments to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA)…
