Introduction 

FOREUM is launching an innovative call to support high-impact clinical research addressing unmet patient needs in RMDs. This call introduces a novel grant model to the FOREUM portfolio whereby an award will be made to support the creation of a dedicated clinical trial collaboration, led by a single principal investigator who must be from a EULAR member country. The trial collaboration must utilise the EULAR-ENTRI network.

 

Objectives 

This call seeks proposals to perform pragmatic trials or treatment strategy studies that will improve real-world patient outcomes, reduce disease burden, and optimise treatment strategies for patients with RMDs. This call will be underpinned by the collaboration between FOREUM and the EULAR-ENTRI network, leveraging its capacity to accelerate clinical research within the EULAR RMD ecosystem.

 

Scope 

Eligible projects include clinical pragmatic trials, strategy trials, and experimental medicine studies focusing on patient-relevant outcomes. The proposal’s research question may be linked to both common and/or rare RMDs and may focus on a single or group of disorders. Such projects should not only advance the future management of patients with RMDs but also consolidate the EULAR-ENTRI network as the ‘go-to’ partner for the conduct of clinical studies that will rely for their success on high-quality trial design and delivery expertise, usually integrated across distinct clinical trial centres across the EULAR region.

 

Eligibility and Requirements 

Main applicant

Eligible applicants will be established academic researchers based in a EULAR member country. Given the wide scope of potential clinical studies, only one lead application can be submitted per centre, and each proposal must be accompanied by approval from the relevant director of the submitting institute.

ENTRI Network Model

Applicants do not need to identify participating ENTRI centres at either Stage 1 (LoI) or Stage 2 (Full Proposal) of the application process.

Once a project has been selected for funding, the participating ENTRI centres must be identified in collaboration with the relevant EULAR-ENTRI responsible members, before the contract is signed.

At that stage, confirmation will be required from each participating centre that it agrees to collaborate on data analyses and/or provide aggregated or raw data, in accordance with applicable national regulations and the requirements of its governing bodies.

Patient Involvement

Active involvement of Patient Research Partners (PRPs) is mandatory throughout the study lifecycle as per EULAR and FOREUM guidelines. The role of PRPs is part of the proposal evaluation.

Ethical Considerations

FOREUM expects a high standard in the conduct of research it funds. For researchers this includes scientific integrity and adherence to the principles of good research practice. Patients involved in the study must be treated in accordance with the Declaration of Helsinki.

Data sharing and collaboration

Applications must include confirmation that participating centres agree to collaborate on data analyses and / or provide aggregated or raw data in accordance with applicable national regulations and the requirements of their respective governing bodies. This attestation can be added to the application as soon as participating centres have been defined.

Expected Impact

Projects should generate practice-changing evidence and demonstrate the added value of ENTRI-based trial execution.

 

Budget 

Up to 500,000 EUR for one project over a three-year period.