Launch of New HMA-EMA Catalogues of Real-World Data Sources and Studies

The introduction of the HMA-EMA RWD Catalogues on 15 February 2024 represents a significant advancement in the field of healthcare research, specifically in pharmacoepidemiology and pharmacovigilance. This initiative is a part of broader efforts to harness real-world data (RWD) for improving the development, approval, and monitoring of medications. Real-world data comprises information collected from sources outside of traditional clinical trials, including electronic health records, insurance claims, patient registries, and wearable devices. By effectively utilizing RWD, healthcare stakeholders can gain insights into drug effectiveness, safety, and patient health outcomes in real-world settings.

The context for this development is the growing recognition of the value of real-world evidence (RWE) in complementing data obtained from randomized controlled trials (RCTs). RWE is increasingly being used to make regulatory decisions, guide clinical practice, and support healthcare policy. The Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in the European Union, among other regulatory bodies, have issued guidelines and policies to encourage the use of RWE in drug development and approval processes.

The HMA-EMA RWD Catalogues aim to address several challenges in the RWD landscape:

1. Discoverability: One of the major challenges in the use of RWD is identifying relevant and high-quality data sources that can answer specific research questions. The new catalogues facilitate this by providing searchable repositories of data sources and studies, making it easier for researchers and regulators to find the information they need.

2. Assessment of Data Quality and Suitability: Assessing the quality and suitability of RWD sources for specific research purposes can be daunting. The catalogues offer detailed information on data sources, including study protocols and reports, to aid in this assessment.

3. Interoperability: The lack of standardization and interoperability between different RWD sources and studies has been a barrier to effective RWE generation. The catalogues' use of globally unique identifiers and support for collaborative research efforts aims to improve this aspect.

4. Transparency and Security: Ensuring the transparency of research processes and the security of data are critical concerns. The enhanced security measures and the ability to directly download study documents contribute to addressing these issues.

The catalogues not only serve as an evolution of previous resources like the EU PAS Register? and the ENCePP Resource Database but also embody the principles of FAIR data—making data Findable, Accessible, Interoperable, and Reusable. This aligns with global trends towards open science and data sharing to accelerate research and improve patient outcomes.

In summary, the HMA-EMA RWD Catalogues are part of a larger shift towards the integration of real-world evidence in healthcare decision-making. They represent a tool to enhance the efficiency, quality, and transparency of research using real-world data, ultimately aiming to improve the evidence base for the safety, efficacy, and effectiveness of medicines.

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ABOUT STUART MCCULLY

Stuart is a real world research (RWR) regulatory scientist and thought leader.?With his background as a pharmacologist working on traditional pre-approval clinical trials, he became frustrated with the operational inefficiencies and support gaps for non-interventional (observational) studies. As a result, Stuart created CHCUK which became a global leader in supplying regulatory and operational intelligence for non-interventional studies. Currently, Stuart is a co-founder of RWR-Regs, a regulatory compliance solutions platform for real world research.