WP1 is the foundation of GREG, leading the co-creation of evidence-based practical guidance for the use of real-world data (RWD) and real-world evidence (RWE) in regulatory and health technology assessment (HTA) decision-making. Led by the Aragonese Institute of Health Sciences (IACS) and co-led by Novo Nordisk, this work package ensures that GREG’s outputs are scientifically robust, stakeholder-driven, and actionable—bridging the gap between data and decision-making.
WP1 systematically reviews existing RWE guidelines, maps stakeholder needs, and collaborates with WP2 (Regulatory) and WP3 (HTA) to develop iterative, living guidance that evolves with new evidence and stakeholder feedback. Key activities include:
- Continuous systematic reviews of RWE guidelines and recommendations (e.g., EMA, ICH, CIOMS) to identify gaps and best practices.
- Stakeholder engagement through fora and advisory boards to elicit needs, challenges, and adoption barriers from regulators, HTA bodies, payers, and industry.
- Data reuse and adoption challenges: Assessing how emerging EU regulations (e.g., European Health Data Space) impact RWD sharing and RWE generation, with a focus on privacy, interoperability, and ethical compliance.
- Co-creation of the GREG Guidance: A living document integrating lessons from WP4–6 use cases, regulatory/HTA fora, and patient perspectives (via WP7). The guidance will include:
- Needs assessments for regulation and HTA.
- Methodological and data reuse challenges.
- Tools and templates for RWE generation and submission.
WP1 doesn’t just compile guidance—they are also tasked with constantly updating and making guidance available to stakeholders. To achieve this, work has begun on ensuring that the knowledge base is accessible through the GREG Chatbot that will employ the RAG (retrieval, augmentation, and generation) system to provide up-to-date knowledge in response to stakeholder queries. By addressing adoption challenges (e.g., data access, methodological consistency, stakeholder alignment) and aligning with HealthData@EU and EHDS, WP1 paves the way for faster, more reliable RWE to inform decisions on medicines, medical devices, and drug-device combinations.
Besides being led by IACS and Novo Nordisk, WP1 counts on critical contributions from: Erasmus University Medical Centre Rotterdam, Erasmus University Rotterdam, GetReal Institute, the University of Dundee, the University of Galway, Bayer, Gore, Servier, Sanofi, Pfizer, Johnson & Johnson, Medtronic, GSK, Amgen, the European Society of Cardiology, the University of Oxford, Edwards Lifesciences, and the National Institute for Health and Care Excellence.
Enrique Delgado Bernal, WP1 Lead from IACS:
In GREG, a dedicated workstream (WP1) will co-create practical guidance, eliciting stakeholders’ needs, addressing challenges in the generation of Real-World Evidence at each stage of the medicines’ and devices’ life-cycle, synthesising best practices and building an AI-agentic queryable knowledge base making GREG intelligence readily available.
Helene Nordahl, WP1 Lead from Novo Nordisk:
In WP1, our focus is on collaboratively developing evidence-based guidance integrating Real-World Evidence for both HTA and regulatory decision-making. This work is driven by the belief that such guidance must be practical, meaningful, and sustainable.
Meet GREG: Work Package 1 video:
