2018 - BeNeFIT I: call for comparative effectiveness studies

First BeNeFIT call for comparative effectiveness studies

The effectiveness of existing health care interventions is not yet sufficiently compared in clinical trials (e.g. comparisons between medication and surgery, operating or not operating). Moreover, a lot of research is not practice-oriented, so the results are not immediately usable in daily medical practice. Comparative, practice-oriented studies contribute to better patient care and more efficient use of public resources. Therefore in the Netherlands the government finances such studies through the ZonMw programs ‘Rational Pharmacotherapy’ and ‘Health care efficiency research’. In autumn 2015, the Belgian Minister of Public Health, Maggie de Block gave KCE the mandate to select and fund such comparative effectiveness clinical studies programme (KCE Trials).

The Belgian Health Care Knowledge Centre (KCE) and ZonMw, the Netherlands Organisation for Health Research and Care innovation, are now joining forces to launch a joint call for comparative, practice-oriented clinical studies under the name ‘BeNeFIT’. Both organisations contribute 3 million euro each to this call.

The purpose of BeNeFIT (Belgium-Netherlands Funding of International Trials) is that Belgian and Dutch institutions together carry out non-commercial practice-oriented research which is immediately relevant to patients, caregivers and policymakers in both countries.

Scope

The first 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 (including no treatment or placebo) 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 a real-life situation). Accepted study interventions are not limited to drugs or medical devices but also include a broad range of interventions, such as psychotherapy, diagnostic tests or surgery. Study 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 non-commercial.

Out of scope:

Implementation research, defined as “the scientific study of methods to promote the uptake of research findings in practice”
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.
Development studies, innovation studies
Prevention, screening (early detection) or tests to predict risk or response. An exception is healthcare-related prevention, including relapse prevention. This is aimed at preventing an existing condition leading to complications, limitations, a lower quality of life or mortality. The target group therefore consists of patients. That is appropriate within this subsidy round.
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

8th May 2018 14.00h

Who can submit

Research teams from Belgium and the Netherlands can apply to this call. The sponsor* (lead centre with main applicant) should be located in one of the two countries and should be supported by a 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 law of May 7, 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.
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

$If not possible, please justify