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Description de l’appel

Programme :

2024 - BeNeFIT4: Fourth BeNeFIT call for comparative effectiveness studies

Organisation :

KCE & ZonMw

Deadline :

28/12/2024 - Internal deadline

Deadline2 :

28/01/2025 - Pre-proposal

Type d'information :

Financement

Type de programme :

Appels à projets de collaboration internationale, Appels à projets de recherche fondamentale/ou de base (hors financement de l’Union Européenne)

Description courte :

In clinical practice, many treatments have not been thoroughly evaluated, making it unclear whether a patient benefits from a particular treatment, or which treatment is actually preferable. Evaluation of clinical practice is relevant to health care stakeholders in Belgium and The Netherlands and by working together, clinical evaluation trials can be carried out more quickly and efficiently.

Description complète :

In 2017 KCE and ZonMw launched the joint program BeNeFIT. In this initiative, a funding selection
process was developed that integrates approaches from both organisations. The main focus of the
program is to provide funding for non-commercial practice-oriented research that is immediately relevant
to patients, caregivers and policymakers in Belgium and The Netherlands and is conducted in
collaboration by institutions from both countries.

Comparative effectiveness research compares the effectiveness and cost-effectiveness of treatments
that are part of health care in daily practice. Studies are focused on health benefits for the patient, but
also evaluate costs. In Belgium the government finances these studies through the KCE Trials program
of the Health Care Knowledge Centre (KCE) and in The Netherlands funding is provided by the
Organisation for Health Research and Development (ZonMw) programs Efficiency Studies and
Rational Pharmacotherapy , commissioned by the Ministry of Health, Wellbeing and Sports (VWS).

AIM OF THE CALL
The aim of the call is to provide funding for clinical trials that compare the effectiveness of existing health
care interventions that are already in use in the given indication, e.g. comparisons between two
medications, medical therapy versus surgery, trials investigating optimal timing of surgery etc. The
research should be pragmatic and practice-oriented.

Trials funded within the BeNeFIT program must be of non-commercial nature. The different treatment
options that are compared in a BeNeFIT trial should concern treatments that are (or have the potential
of being) reimbursed by health care payers in Belgium and The Netherlands. Moreover, each BeNeFIT
trial should have the potential of generating results with an immediate and important impact on the
efficiency of the health care systems in Belgium and The Netherlands.

Critères d’admission/attribution :

Who can submit to the BeNeFIT4 Call?
Research teams from institutions in Belgium and The Netherlands can apply to this call. The Sponsor
(the main applicant, who shall also be the Sponsor of the Trial under ICH/GCP) should be located in
one of the two countries and should be supported by a National Coordinating Centre in the other country.
Both Belgian and Dutch centres should participate, ideally with a good regional spread.

Belgium
- In Belgium, the Sponsor or the National Coordinating Centre should be a non-profit organisation that
can function as Sponsor/National Coordinating Centre of non-commercial multicentre trials and has
the ability to comply with all Sponsor/National Coordinating Centre related obligations.
- If there is a commercial interest in the study (e.g. the study requires the use of drugs, apps or medical
devices), an exclusivity criterion comes into play. In general, the results of the study cannot bring a
potential benefit to a single company only.
- Participating centres should include at least one centre from each region (Flanders, Wallonia and
Brussels).
- The funding granted under the research agreement complies with the European state aid regulations.

The Netherlands
- In The Netherlands, the Sponsor or the National Coordinating Centre must be a research organisation or care institution.
- At least one of the participating institutions in The Netherlands should be a non-academic hospital.
- Studied interventions should be (or have the potential of being) reimbursed under the "Basic Health Care" Act and/or the "Long Term Care" Act packages in the Netherlands.
- Studies should fall within the scope of the "Efficiency Studies" program or the "Rational Pharmacotherapy" program of ZonMw. For detailed information please consult the websites of ZonMw for "Efficiency Studies" and "Rational
Pharmacotherapy".
- No grants will be awarded by ZonMw if this would or could constitute unlawful state aid. Therefore, the following state aid measure applies to this funding round: Exemption Decision for Services of General Economic Interest (SGEI; In Dutch :"Diensten van Algemeen Economisch Belang"(DAEB)). For the purposes of this call for grant applications, ZonMw will consider proposed project activities as SGEI. This means that there are specific conditions for funding and rules for budgets.

A National Coordinating Centre must be assigned in the country where the Sponsor (main applicant) is
not located.

Sponsor and the National Coordinating Centre have to submit a letter of commitment, using the appropriate template and signed by the legal representative of the institution, together with the application. In case of co-financing, also the co-financer of the research will need to submit a signed letter of commitment.

Scope
The BeNeFIT call focuses on comparative effectiveness trials which show clear value for money and have the potential for return on investment. Comparative effectiveness trials compare the benefits and harms of different treatment options that are already in use in the healthcare system in the given indication but which have never been adequately compared directly (i.e. which of two treatments work better in daily practice). Studied interventions must already be in use in daily practice for the studied indication in both countries. Accepted trial interventions are not limited to drugs or medical devices but also include a broad range of interventions, such as psychotherapy, diet, diagnostic tests or surgery. No treatment or placebo are also accepted as trial interventions. Proposals will be selected based on the need for evidence in clinical practice, possible efficiency improvement and potential return on investment for the health care systems.

The primary aim of the trial must be of a non-commercial nature. In addition, the holder of the intellectual property rights (IPR) on the studied intervention or comparator to which the experiment relates is neither directly nor indirectly the Sponsor of the experiment. The Sponsor exercises the IPR to the concept of the experiment, its implementation and the scientific data resulting from it. The Sponsor, National Coordinator and research team should have no conflict of interest with regards to the performance and possible results of the trial.
The trial should have a randomised (at individual level or in clusters) and multi-centre design.£

Out of scope

- If the primary aim of the studied intervention is to promote the uptake of research findings, the study is considered implementation research, which is out of scope. Interventions that aim to improve implementation of guidelines or quality of care are also out of scope.
- Health services research that studies the organisation of care (at macro, meso or micro level). This call offers no scope for research involving organizational innovations, such as task rearrangement, offering the intervention at another location or logistical organization of care.
- Interventions that have been used only within the framework of clinical research or pilot testing are out of scope.
- Studies of medicinal products or medical devices that are not marketed in Belgium and The Netherlands. Devices should have a CE label. Off-label use that is well established in usual care is accepted.
- Prevention, screening (early detection) or tests to predict risk or response. An exception is healthcare-related prevention, including relapse prevention. Preventive measures that target a group of patients with an existing condition and aim to reduce complications, limitations, or mortality, or increase quality of life are in scope.
- Studies that already have been submitted to authorities, ethical committees and/or have already started recruitment.
- Interventions that are not eligible for possible reimbursement in at least one of the two countries.

Financement :

The total duration of the proposed trial should be realistic and is not allowed to exceed 10 years. For the budget of the proposed trial no maximum is defined. The proposed budget of the trial must be reasonable, commensurate with the work involved and follow the principles of the budget tool published with this call text. A thorough evaluation of the proposed budget is part of the assessment procedure. The available budget for this call is 9.2 million euros in total.

Pour postuler / aide du Département Recherche :

If you are interested in submitting a proposal for this call, it is mandatory to contact the Grant Management of H.U.B ( Grants.DCR.HUB@hubruxelles.be ) before 28 December 2024.

-For more information and if you have additional questions, please contact David Bergemann

Applications are made via the application portal using standard application forms made available on the KCE website

Contact interne ULB :

David Bergemann (H.U.B)

Institut Jules Bordet Rue Meylemeersch 90 (Rez Haut Nord) B-1070 Anderlecht Belgium

+32 (0) 2 541 34 66

David.Bergemann@hubruxelles.be

Grants.DCR.HUB@hubruxelles.be

Contact externe :

trials@kce.fgov.be

https://kce.fgov.be/fr/kce-trials/calls/2024-benefit4-fourth-benefit-call-for-comparative-effectiveness-studies-with-zonmw

Vous souhaitez recevoir de l’information destinée à quel type de profil :

Chercheurs

Discipline(s) scientifique(s) de l’appel :

Médecine, Santé publique

Documents :

Nom	Fichier
BENEFIT_Full-call-text	BeNeFIT4_Call_Text.pdf

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