Project description
Leveraging real-world data to assess inflammatory bowel disease treatment
Evaluating the benefit-risk balance of treatments is essential in medicine but presents challenges, particularly in inflammatory bowel diseases (IBD). Although new therapies are available, their optimal position is unclear due to the absence of head-to-head comparison. Recent emulated trials have highlighted the effectiveness of real-world data in assessing IBD treatments. The ERC-funded FORECAST project aims to validate algorithms that identify patient characteristics and outcomes using nationwide healthcare databases. It will emulate clinical trials comparing advanced therapies in IBD, integrate findings with patient preferences into a clinical decision support system and evaluate this system through a pragmatic randomised controlled trial. The project will also establish post-marketing drug surveillance methods applicable to future IBD therapies and other chronic diseases.
Objective
Assessing the benefit-risk balance of treatment is crucial in medicine to select the most appropriate treatment for patients. This process faces major challenges, how to implement evidence in real time to guide treatment choice and how to summarize efficacy and safety outcomes to patients and clinicians, while incorporating patient preferences. Inflammatory bowel diseases (IBD) affect 3 million residents in Europe. New advanced therapies have been recently approved, but in the absence of head-to-head randomized controlled trials (RCT), data are lacking to position each drug in the therapeutic management. Multiple types of real-world data (RWD) sources are available to assess the effect of treatment, but each type has its proper strengths and limitations. Linking multiple RWD sources can overcome limitations and leverage the strengths of each data source. We recently emulated clinical trials supporting the use of RWD to assess treatment effectiveness and safety in IBD.
Based on the linkage of nationwide healthcare databases, electronic health records, and a prospective cohort of IBD patients, the aims of the current proposal are (i) to validate algorithms identifying IBD characteristics and outcomes in nationwide healthcare databases, (ii) to emulate head-to-head clinical trials comparing advanced therapies in IBD, (iii) to incorporate trials findings and patient preferences in a clinical decision support system for IBD patients and clinicians, whose impact will be assessed by a pragmatic RCT nested in nationwide healthcare databases.
This challenging project will involve multi-disciplinary aspects, from qualitative approach to artificial intelligence, to clarify the position of each treatment in IBD and disseminate findings to patients and clinicians. Besides scientific importance, it will have societal impact by setting the stage for a novel post-marketing drug surveillance framework applicable not only to future IBD treatments but also to other chronic diseases.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
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Keywords
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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HORIZON.1.1 - European Research Council (ERC)
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Topic(s)
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Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
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Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
HORIZON-ERC - HORIZON ERC Grants
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Call for proposal
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Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) ERC-2024-STG
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
75006 PARIS
France
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