Chantal van Gils, MD, PhD, Director of Epidemiology and Real-World Evidence, NDA Advisory Board, NDA Group, published in MedNous, November/December 2022

This commentary provides a comprehensive overview of the regulatory framework for real-world data progress. Real-world evidence (RWE) and real-world data (RWD) are differentiated, paving the way for the analysis of current trends and legislation in the regulatory landscape.

 There is no doubt that the use of big data and RWE has come closer to the practice of medical innovation. The “Big data” is likely to be utilized throughout a product's entire lifecycle due to its increasing volume and complexity across multiple settings and devices. It is, however, necessary to acknowledge the validity of the analytical and epidemiological methodologies used to deliver robust evidence to accept these data.

In this article Chantal discusses both the supply and demand for RWD inclusion, focusing on two fundamental aspects: interoperability and quality assurance as a base for the current Regulatory framework.

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Additional Information:

In early 2022, The European Medicines Agency (EMA), set up a joint task force and launched the Data Analysis and Real-World Interrogation Network (DARWIN EU), a network of databases across the EU complemented by expertise and services at the DARWIN EU Coordination Center. The HMA-EMA joint Big Data Steering Group has released two draft guidance documents.

Data Quality Framework for EU medicine regulation sets out quality criteria for data used in medicine regulation and acts as an umbrella to identify, define and further develop data quality assessment procedures and recommendations for current and novel data types.

Good practice guide for the use of the Metadata Catalogue of Real-World Data Sources focuses specifically on the discoverability of RWD. The guide provides recommendations on how to use the catalogue of real-world metadata that is currently being built and in late 2023, will replace the existing RWD catalogue of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).

The US Food and Drug Administration (FDA) has started to encourage the use of RWE and has released concrete draft guidance on considerations for the use of RWD and RWE to support regulatory decision-making. The guidance is aimed at generating a better understanding of how RWD and RWE can fit into the regulatory process.


The Author

Dr Chantal van Gils

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