BeNeFIT 2020: Second BeNeFIT call for comparative effectiveness studies

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.

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 (with ‘no treatment’ or placebo being one of the possible treatment options) that are already in use in the health care system in the given indication but which have never been adequately compared directly (i.e. which of 2 treatments work better in daily practice). Accepted study 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. Proposals will be selected based on the need for evidence in clinical practice and possible efficiency improvement and potential return on investment for the health care systems. The primary aim of the trial should be of a non-commercial nature.

Out of scope:

  • Implementation research, defined as “the scientific study of methods to promote the uptake of research findings in practice”. 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. (Appropriate in this subsidy round are preventions that target a group of patients with an existing condition leading to complications, limitations, a lower quality of life or mortality.)
  • Studies that already have been submitted to authorities, ethics committees and/or have already started recruitment.
  • Interventions that are not eligible for possible reimbursement in at least one of the two countries.

Deadline

14th January 2021 14.00h

Who can submit

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. In Belgium, both French-speaking and Flemish centres should participate.

* As defined in ICH-GCP

Additional country-specific criteria

Belgium

  • If the sponsor is located is Belgium, the sponsor 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 Netherlands

  • If the sponsor is located in the Netherlands, the sponsor should be a research 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 “Health care efficiency research” (DoelmatigheidsOnderzoek) programme or the “Rational Pharmacotherapy” (Goed Gebruik Geneesmiddelen) programme 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

Call text

You can find the complete call text here.

Links & Downloads

Call text (pdf)

ZonMw Projectnet portal

ProjectNet short user manual (pdf)

Application form Research Outline (Word)

Budget tool (Excel)+ guidance (pdf)

BeNeFIT Estimation of potential revenues (Excel)

Template letter of commitment sponsor (word)

Template letter of commitment coordinating centre (word)

Template letter of commitment co-financer (word)

Explanation Code for dealing with Personal Interests (pdf)

Code for dealing with Personal Interests (pdf)

Timelines (pdf)

Terms and Conditions Second Benefit Call (pdf)

Consortium agreement template (word)
 

 

Contact
KCE Trials
+32 2 287 33 88
Published on: 
2020/10/16