As the pharmaceutical and medical device industries increasingly rely on real-world data (RWD) and synthetic data, regulators and HTA bodies face the challenge of conducting targeted validations to independently verify claims independently. The five research projects, namely REALM, More- EUROPA, ONCOVALUE, Real4Reg and REDDIE fall under the same call - HORIZON-HLTH -2022- TOOL -11-02.
Through collaborative efforts, the cluster aims to advance the field by exploring innovative approaches to leverage real-world and synthetic data for regulatory decision-making and HTA. By improving the evidential value of these data and promoting their usability, the cluster aims to contribute to improving regulatory practise and health technology assessment.
REALM – visit the website
The REALM project aims to create a platform for evaluating and certifying healthcare software used in medical equipment, electronic health records, health tracking apps, and remote medicine. By integrating global regulatory guidelines and leveraging real-world data, the platform will facilitate the assessment of medical software to ensure adherence to quality standards. The project will implement five software projects across three European countries, utilizing artificial intelligence technologies to support technology assessment and regulatory decision-making.
Real4Reg – visit the website
The evidential value of data for broader use cases, such as in the pre-authorisation and evaluation phase of medicines, is limited by the variability of data and the challenges of analysing data from different environments and sources. The project focuses on developing new and optimised methods for RWD analysis relying on highly relevant use cases from regulatory practise and the entire product life cycle. Real4Reg will implement the results into existing and emerging guidelines for health authorities and health technology assessment bodies across Europe.
ONCOVALUE – visit the website
The key objective of the ONCOVALUE project is to collect and analyse RWD from European cancer hospitals and institutes as a means of assessing the effectiveness of novel cancer therapies. The consortium will use AI technologies to transform unstructured data from medical notes and images into real-world evidence made available to clinicians for treatment decision-making, and to regulatory bodies for developing guidelines. Collectively, ONCOVALUE will contribute to safer and more efficient therapies and technologies.
More-EUROPA – visit the website
Real-world data (RWD) has the potential to contribute to the understanding of drug effects alongside clinical trials. The project focuses on patient registries as a type of RWD and aims to formulate methodologies and standards to establish these data as evidence for the regulatory approval and health technology assessment of medicinal products in Europe.
Other related projects and initiatives
The European Health Data Space (EHDS) is an initiative led by the European Union to establish a protected and distributed digital infrastructure for the transfer and collaboration of health data among member countries. Its primary objective is to enhance health research, patient care, and disease prevention by enabling access to top-notch health data, all the while safeguarding patient privacy and data security.
Visit the EHDS website
The Data Analysis and Real-World Interrogation Network (DARWIN EU®) is a collaborative effort between the European Medicines Agency (EMA) and the European Medicines Regulatory Network. It aims to establish a coordination centre that gathers accurate and timely evidence on the utilization, safety, and efficacy of medicines for human use, including vaccines. This evidence is derived from real-world healthcare databases across the European Union (EU).
Visit the DARWIN EU® website
The European Network for Health Technology Assessment (EUnetHTA) is a European initiative that promotes collaboration among HTA organizations. Its goals include efficient resource use, knowledge sharing, and promoting good practices in HTA methods and processes. By working together, EUnetHTA aims to provide reliable and timely information to support HTA activities across European countries.
Visit the EUnetHTA website
The National Institute for Health and Care Excellence (NICE) provides evidence-based guidelines for healthcare professionals and decision-makers, aiming to deliver optimal patient care while ensuring efficient use of taxpayer funds. Their efforts ensure that healthcare professionals have access to reliable information and recommendations to deliver the best possible care to patients.
Visit the NICE website