Widespread use of real-world evidence in EU medicines regulation

Widespread use of real-world evidence in EU medicines regulation. Is it possible by 2025?

That’s certainly the aim and vision of the European Medicines Agency

Real-world data (RWD) and real-world evidence (RWE) are already partially used in the regulation of the development, authorization, and supervision of some selected medicines across the EU, but the vision is that by 2025 the use of RWE will have been fully enabled and the value will have been established across the whole spectrum of regulatory use cases.

Aiming to complement rather than replace randomized clinical trials (RCTs), which are currently the gold standard demonstrators of the efficacy of a medicine, the vision is that both RWE and RCTs strengths will be jointly utilized in accordance with their importance to each regulatory question, and that a rigorous and systematic approach to ‘learning from doing’ be established.

To aid this objective, the agency is creating a ‘Data Analytics and Real World Interrogation Network’ which they say will be key to delivering this vision. This EU-wide network, due to launch early next year, will allow access to healthcare data from across the EU and will onboard data partners to drive the conduct of studies requested by medicines regulators and, at a later stage, by other stakeholders.

If successful, delivering it will support the development and use of better medicines for patients, and of better information for healthcare professionals, industry, regulatory and public health agencies, academia, and more.

As providers of a plethora of pharma services, including clinical trials, in their own in-house facilities, QUINTA-ANALYTICA support and encourage such forward-thinking, and indeed any other proposal whose goal aligns with theirs - that of enabling the best medicines that science can offer.

Learn more about Quinta’s services and ethos by getting in touch with us today.

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