2023 - BeNeFIT II: call for comparative effectiveness

In July 2020 the Belgian Health Care Knowledge Centre (KCE) and The Netherlands Organisation for Health Research and Development (ZonMw) agreed to invest 9 million euros in the second call of the Belgium-Netherlands Funding of International Trials (BeNeFIT) program.

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.

Health care efficiency 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 KCE Trials and in the Netherlands funding is provided by the ZonMw programs ‘Efficiency Studies’ and ‘Rational Pharmacotherapy’, commissioned by the Ministry of Health, Wellbeing and Sports.

In 2017 KCE Trials and ZonMw launched the joint program BeNeFIT. 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 research institutions from both countries.

Selection of research outlines submitted to this third BeNeFIT call has taken place in April 2023. The BeNeFIT call steering committee (CSC) now invites selected research teams to submit their full research proposal (FRP).

Deadline

5th September 2023 14.00h

Who can submit

Research teams from institutions in Belgium and the Netherlands that have been selected and invited to submit a FRP by the CSC can further 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. In Belgium, both French-speaking and Flemish centres should participate, ideally with a good regional spread.

* As defined in ICH-GCP

** In case of co-sponsorship: co-sponsors must enter into an agreement that complies with applicable laws and the provisions of the Terms and conditions of the Third Benefit Call. All co-sponsors will be jointly and severally liable towards the Funding Agencies for the compliance with the provisions of these Terms and Conditions and (if applicable) with the provisions the research agreement that incorporates them. In case of co-sponsorship, one co-sponsor must act as main applicant.

Additional country-specific criteria

Belgium

In Belgium, the sponsor or the national coordinating centre should qualify as non-commercial sponsor under the applicable laws, including the Belgian law related to experiments on human people (May 7th, 2004).
Participating centres should include at least one centre from the Flemish and the French speaking part of the country.$
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^p.
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 (“basispakket Zorgverzekeringswet” and “Wet langdurige zorg”) in The Netherlands.
Studies should fall within the scope of the “Efficiency Studies” (DoelmatigheidsOnderzoek) program or the “Rational Pharmacotherapy” (Goed Gebruik Geneesmiddelen) program of ZonMw. For detailed information please consult the website of ZonMw.

p Definition (OOI kaderregeling): Onderzoeksorganisatie en zorginstelling (artikel 5, lid 1, wet toelating zorginstellingen)

$If not possible, please justify