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Real4Reg is a project funded by the European Union (Horizon Europe). It started in January 2023 and has a 48-month duration. – Grant agreement ID: 101095353.

Real4Reg aims to develop, optimise, and implement artificial intelligence methods for real-world data (RWD) analyses in regulatory decision-making and health technology (HTA) assessment along the product lifecycle.

The findings will inform training activities on good practice examples and will be implemented in existing and emerging guidelines for both health regulatory authorities and HTA bodies across Europe.
Real4Reg supports better decision-making about medicines and ultimately benefits patients’ health.

Consortium Partners

Ten consortium partners from six European countries are working on the project. They include experts from regulatory agencies/Health Technology Assessment (HTA), academia, and patient organisations, and will also be supported by a stakeholder’s advisory board.

Traditionally, clinical evidence generated from randomised controlled trials (RCTs) is used both for marketing authorisation and HTA of a new medicinal product. However, there are limitations in terms of the generalisability of results to the target patient population and the statistical power to detect rare events. Moreover, few RCTs can answer all important research questions for healthcare decision-makers due to ethical or financial/resource reasons impeding the conduct of RCTs, e.g., due to the severity and rarity of a disease.

Effectiveness, i.e., the safety and benefits of the treatment, may be very different in real life. Effectiveness estimates provide important information for evaluating treatment strategies and supporting pricing and reimbursement decisions. To address these challenges, pharmaceutical companies and regulators have begun to consider other sources of evidence for rapid evaluation throughout the product lifecycle, making increasing use of data from real-world settings to generate evidence that can support regulatory decision-making and approvals of medicinal products.

While there is long-term experience and understanding of how real-world evidence (RWE) from real-world data (RWD) can be employed in the post-authorisation phase of drugs, e.g., monitoring and analysing safety signals of medicines or identifying further subpopulations with unique risk profiles for effectiveness analyses, the use of RWE from RWD in pre-authorisation and evaluation steps, including drug development, is still scarce. Further, the use of RWD in post-authorisation steps is often constrained by data availability and by challenges in analysing data from different settings and sources.

For these reasons, the Real4Reg project aims to develop tools and technologies for the effective use of RWD in regulatory decision-making and HTA. By doing so, the Real4Reg consortium will contribute to promoting and protecting human health and well-being and support the transformation of healthcare systems in their efforts towards equitable access to innovative, sustainable, and effective medicines and health care.

Read more on “Use of Real World Evidence (RWE) for regulatory purposes”