Call: New methods for the effective use of real-world data and/or synthetic data in regulatory decision-making and/or in health technology assessment
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Programme | |||||||||
Acronym | HORIZON-HLTH-TOOL | ||||||||
Type of Fund | Direct Management | ||||||||
Description of programme "Horizon Europe - Cluster 1 - Destination 5: Unlocking the full potential of new tools, technologies and digital solutions for a healthy society" | Calls for proposals under this destination are directed towards the Key Strategic Orientation KSO-A ‘Promoting an open strategic autonomy by leading the development of key digital, enabling and emerging technologies, sectors and value chains’ of Horizon Europe’s Strategic Plan 2021-2024. Research and innovation supported under this destination should contribute to the impact area ‘High quality digital services for all’ and in particular to the following expected impact, set out in the Strategic Plan for the health cluster: ‘Health technologies, new tools and digital solutions are applied effectively thanks to their inclusive, secure and ethical development, delivery, integration and deployment in health policies and health and care systems’. In addition, research and innovation supported under this destination could also contribute to the following impact areas: ‘A competitive and secure data-economy’, ‘Industrial leadership in key and emerging technologies that work for people’, and ‘Good health and high-quality accessible health care’. Technology is a key driver for innovation in the health care sector. It can provide better and more cost-efficient solutions with high societal impact, tailored to the specific health care needs of the individual. However, novel tools, therapies, technologies and digital approaches face specific barriers and hurdles in piloting, implementing and scaling-up before reaching the patient, encountering additional challenges such as public acceptance and trust. Emerging and disruptive technologies offer big opportunities for transforming health care, thereby promoting the health and well-being of citizens. Unlocking this potential and harnessing the opportunities depends on the capacity to collect, integrate and interpret large amounts of data, as well as ensure compatibility with appropriate regulatory frameworks and infrastructures that will both safeguard the rights of the individual and of society and stimulate innovation to develop impactful solutions. In addition to existing European Research Infrastructures, the European Health Data Space will promote health-data exchange and facilitate cross-border research activities. This destination aims to promote the development of tools, technologies and digital solutions for treatments, medicines, medical devices and improved health outcomes, taking into consideration safety, effectiveness, appropriateness, accessibility, comparative value-added and fiscal sustainability as well as issues of ethical, legal and regulatory nature. In view of increasing the impact of EU investments under Horizon Europe, the European Commission welcomes and supports cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities such as the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. Opportunities for potential synergies exist between projects funded under the same topic but also between other projects funded under another topic, cluster or pillar of Horizon Europe (but also with ongoing projects funded under Horizon 2020). In particular, this could involve projects related to European health research infrastructures (under pillar I of Horizon Europe), the EIC strategic challenges on health and EIT-KIC Health (under pillar III of Horizon Europe) or in areas cutting across the health and other clusters (under pillar II of Horizon Europe). For instance, with cluster 4 “Digital, Industry and Space” such as on digitalisation of the health sector, incl. health technologies, medical devices and key enabling technologies; assisted, autonomous, independent and empowered living; smart homes; decision support systems; health impact assessment (e.g. related to consumer products, working place innovation). Expected Impacts Proposals for topics under this destination should set out a credible pathway towards unlocking the full potential of new tools, technologies and digital solutions for a healthy society, and more specifically to several of the following expected impacts:
Citizens trust and support the opportunities offered by innovative technologies for health care, based on expected health outcomes and potential risks involved. | ||||||||
Link | Link to Programme | ||||||||
Call | New methods for
the effective use of real-world data and/or synthetic data in regulatory decision-making and/or in health technology assessment |
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Description of call "New methods for the effective use of real-world data and/or synthetic data in regulatory decision-making and/or in health technology assessment" | Expected Outcome
Scope: With the emerging use of real-world data (RWD) and synthetic data by the pharmaceutical industry and medical devices industry, regulators and HTA bodies need to perform targeted validation of claims through independent analysis. The principal aim of this topic is to address the data needs of health regulatory bodies and HTA bodies across the EU, as outlined in the recently published “HMA-EMA Joint Big Data Taskforce Phase II report: ‘Evolving Data-Driven Regulation’” and its associated DARWIN (Data Analysis and Real World Interrogation Network) project. To harness the potential of RWD and synthetic data from digital twins and advanced analytical models, and make them actionable for health regulatory decision-making and for health technology assessment, targeted research is needed on the evidentiary value of these data for a number of relevant use cases. In addition, methods need to be developed to increase the usability of such data by different stakeholder groups. Doing so will contribute to the European Health Data Space and maximise the positive impact of DARWIN in driving up the quality of evidence and decisions on the development and use of medicines and digital health innovations. Access to and analysis of RWD and synthetic data can inform regulatory decision-making throughout the product lifecycle, namely: 1) support product development (e.g. scientific advice, PRIME),); 2) support authorisation of new medicines and digital health innovations; and 3) monitor the performance of medicines and digital health innovations on the market (effectiveness and safety). Eventually, this will put in place methods and processes that will enable continuous learning from pre-authorisation procedures and authorisation applications on the use of RWD and/or synthetic data. Proposals should address all of the following areas:
Proposals should involve researchers who are specialised in the use of real-world data and/or synthetic data to evaluate medicinal products and/or health care digital innovation products and services. Proposals should involve national competent authorities (national health care product regulatory bodies and/or medical device notified bodies) and could involve citizens and patients’ representatives where relevant. Proposals should include capacity-building efforts to address inequalities of health regulatory processes across Europe. This should comprise education and training activities and sharing of best practices. In addition to national competent authorities, proposals could consider the involvement of the European Medicines Agency (EMA) for an added value in order to provide an effective interface between the research activities and regulatory aspects and/or to translate the research results into validated test methods and strategies that would be fit for regulatory purpose. Proposals could also consider the involvement of the European Commission's Joint Research Centre (JRC) to provide added-value regarding health registry data, interoperability, harmonisation and quality and linking with other data. | ||||||||
Link | Link to Call | ||||||||
Thematic Focus | Clustering, Development Cooperation, Economic Cooperation, Research & Innovation, Technology Transfer & Exchange, Health, Social Affairs, Sports, Capacity Building, Cooperation Networks, Institutional Cooperation | ||||||||
Funding area | EU Member
States Overseas Countries and Territories (OCTs) United States of America | ||||||||
Origin of Applicant | EU Member States Overseas Countries and Territories (OCTs) United States of America | ||||||||
Eligible applicants | Education and Training Centres, Federal State / Region / City / Municipality / Local Authority, Research Institution, Lobby Group / Professional Association / Trade Union, International Organization, Small and Medium Sized Enterprises, SMEs (between 10 and 249 employees), Microenterprises (fewer than 10 employees), NGO / NPO, Public Services, National Government, Other, Start Up Company, University, Enterprise (more than 250 employees or not defined), Association | ||||||||
Applicant details | eligible non-EU countries:
At the date of the publication of the work programme,
there are no countries associated to Horizon Europe. Considering the Union’s interest to retain, in principle, relations with
the countries associated to Horizon 2020, most third countries associated to Horizon 2020 are expected to be associated to
Horizon Europe with an intention to secure uninterrupted continuity between Horizon 2020 and Horizon Europe. In addition,
other third countries can also become associated to Horizon Europe during the programme. For the purposes of the eligibility
conditions, applicants established in Horizon 2020 Associated Countries or in other third countries negotiating association
to Horizon Europe will be treated as entities established in an Associated Country, if the Horizon Europe association agreement
with the third country concerned applies at the time of signature of the grant agreement.
Legal entities which are established in countries not listed above will be eligible for funding if provided for in the specific call conditions, or if their participation is considered essential for implementing the action by the granting authority. Specific cases:
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Project Partner | Yes | ||||||||
Project Partner Details | Unless otherwise provided for in the specific call conditions , legal entities forming a consortium are eligible to participate in actions provided that the consortium includes:
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Further info | Proposal page limits and layout: The application form will have two parts:
Page limit - Part B: 45 pages | ||||||||
Type of Funding | Grants | ||||||||
Financial details |
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Submission | Proposals must be submitted electronically via the Funding & Tenders Portal Electronic Submission System. Paper submissions are NOTpossible. |
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