The Innovative Health Initiative announces a funding call to advance evidence-based practical guidance for real-world data and real-world evidence

The Innovative Health Initiative has announced a new funding call for proposals, IHI 6, focused on real-world data (RWD) and real-world evidence (RWE), which aims to address a spectrum of challenges in health research and innovation. 

The Innovative Health Initiative (IHI) aims to transform health research and innovation into tangible benefits for patients and society, ensuring Europe’s leadership in interdisciplinary, sustainable, and patient-centric health research. This collaboration between the European Union and industry associations such as COCIR, EFPIA, EuropaBio, MedTech Europe, and Vaccines Europe operates with a total budget of EUR 2.4 billion. A substantial funding of EUR 120 million is available through IHI calls 6 and 7, sourced from Horizon Europe, the EU’s research and innovation funding program. IHI expects equivalent contributions from its industry partners. 

IHI’s recent funding announcement, IHI 6, is a two-stage call with one of the topics specifically focused on RWE. In this call, IHI is seeking applicants for developing evidence-based practical guidance for sponsors on the utilization of RWD and RWE. Anticipated outcomes include providing stakeholders with structured, evidence-based guidance to support the development, regulatory processes, and decision-making for innovative medicines and health technologies, with a focus on medicinal products, medical devices, and therapeutic products. 

The initiative aims to address the current approach where RWD/RWE submissions are typically tailored to specific use-cases, which demands significant expertise and effort from sponsors and healthcare decision-makers. To address this challenge, the funded action under this topic should: 

• Map relevant RWD/RWE initiatives in Europe and align with existing frameworks, including the European Medicines Agency’s vision
• Identify challenges faced by stakeholders in routine RWD/RWE use for regulatory and HTA decision-making, considering differences in regulatory frameworks
• Collaborate with stakeholders to evaluate existing methodologies, guidelines, and practices for the use of RWD/RWE in healthcare decision-making
• Conduct an in-depth study of diverse RWD/RWE use cases, analyzing methods and variables
• Develop a draft of practical guidance respecting ethical frameworks, EU values, and data quality
• Test the guidance through pilots in various contexts, including diverse areas such as chronic diseases and clinical development
• Finalize the guidance based on pilot learnings and disseminate it widely to stakeholders

The funded project is also expected to explore collaborations with complementary initiatives to advance RWD/RWE in Europe. This includes collaboration with initiatives such as the GetReal Institute, REDDIE, More-EUROPA, Oncovalue, Real4Reg, RWE4Decisions, TEHDAS, QUANTUM, CORE-MD, REALM17, and projects under the ongoing call for proposals HORIZON-HLTH-2024-IND-06-08. The initiative encourages active participation and alignment with these projects, contributing to the collective advancement of real-world evidence practices in Europe. 

The expected impact of this action includes improved access to innovations, informed decision-making across healthcare levels, and expedited market entry of cost-effective products. The initiative aligns with broader European initiatives and guidelines, contributing to the European Health Data Space. The indicative duration of this action is 60 months, allowing flexibility for adjustments during the full proposal stage.