Background
KCE Trials is a national funding programme of clinical research managed by KCE. It funds pragmatic clinical studies that are of high societal importance in Belgium and have no direct commercial purpose. The studies should contribute to better patient care, show clear value for money and should have the potential for return on investment. In this call drug repurposing studies investigating a new indication for an off-patent drug are funded. Study settings can vary from highly specialized hospital care to primary care. All trials are randomised and require a multicentric setting.
Information on the trials that are being funded by KCE Trials Programme can be found under funded trials and on our dynamic dashboards.
Calls for proposals are organised every year. In 2026, several calls will run concurrently depending on the type of study proposal. This webpage describes the criteria for participation and selection for the 2026 drug repurposing call. The total budget available for all the 2026 calls is € 8.0 million with the aim of funding 4-7 studies across all calls.
Scope
Inclusion criteria
Repurposed drug:
- The drug is authorised, commercialised and available in Belgium (or in use in daily practice in Belgium).
- The drug is off-patent in Belgium and in the European Union.
- The safety profile is well known in humans
- The new indication is not the logical consequence or the direct extension of the current indication for which the medicinal product is authorised.
- There is substantial underlying peer-reviewed evidence that supports moving to a large-scale confirmatory randomised trial.
The primary aim of the study is non-commercial, this means:
- The candidate sponsor (and the BCC, if applicable) should be a non-profit organisation or institution that can function as sponsor of non-commercial multicentre trials and has the ability to comply with all sponsor related obligations.
- The candidate sponsor (and the BCC, if applicable) and the members of the research team are not the holders of existing intellectual property rights (e.g. patent) on the drug to which the experiment relates.
- The candidate sponsor (and the BCC, if applicable) and the members of the research team have no conflict of interest with regard to the conduct and possible results of the trial.
- The sponsor exercises the intellectual property rights to the concept of the trial, its implementation and the scientific data resulting from it.
- The funding granted under the research agreement complies with the European state aid regulations.
Design
- The trial is randomised (at individual level or in clusters) and multicentric (with at least one recruiting centre in each region, unless there is a good justification not to do so).
Exclusion criteria
Started studies
- Studies for which recruitment has already started in Belgium, or which have already been submitted to a Belgian ethics committee and/or to the FAMHP (Federal Agency for Medicines and Health products) are out of scope. International studies that have already started abroad (but not in Belgium) are eligible if all other criteria are met.
Development and innovation studies
- Proof of concept studies are out of scope.
- Studies primarily focused on reformulating a medicinal product are out of scope.
Studies that have already been submitted twice to the KCE Trials programme
- An application that has been declined can be resubmitted once in a KCE Trials call. In this case, the applicant should clearly state which changes were made and how the concerns of the previous review were addressed. If the application is declined again, a similar project will no longer be eligible for KCE Trials funding.
Other studies that are out of scope for the drug repurposing call but could be submitted to the KCE Trials comparative effectiveness call
- Studies about the use of medicines in groups not covered by the existing marketing authorisation (e.g. children, the elderly and pregnant women).
- Studies about the use of medicines that is already widely established in practice and has been incorporated into the guidelines.
Who can submit to the 2026 drug repurposing call?
This call is investigator-led, meaning that investigators conceive the research and develop the study proposal.
Sponsor in Belgium (Belgian studies)
The investigator should have the support of a Belgian non-profit organisation or institution (usually a hospital or a university) that is willing to act as the sponsor of the trial and has the ability to comply with all sponsor related obligations. It is strongly recommended that studies are developed and conducted with the support of a clinical trial centre (CTC) or equivalent.
In general, participants must be recruited in Belgium. If funding is requested for a minority of participants recruited abroad, justification should be provided and will need to be approved by KCE. For trials with a large number of participants recruited abroad, participation of other funders will be required to cover site costs for those participants and to contribute to the sponsor costs.
Sponsor abroad (International studies)
The participation of Belgian centres to an international non-commercial trial within the scope of this call is also eligible for funding. KCE Trials will provide funding for the participation of Belgian centres through a Belgian Coordinating Centre (BCC). The sponsor abroad and the BCC should both be non-profit organisations or institutions.
Call text
You can find the complete call text here.
How to submit?
- The call will be open to submissions from 19th May 2026 until 13h on 22nd September 2026.
- As a first step, candidates are invited to submit a Research Outline (RO). Shortlisted candidates will be invited to submit a Full Research Proposal (FRP) (including the study protocol) later in the process.
- All submissions must be made through the KCE Trials online submission platform. Once you have created an account, you will find information to start your submission under the “funding opportunities” tab.
- You may prefer to prepare your application using the application form in Word format for your convenience (applications submitted using the Word template will not be accepted). This document also provides guidance on how to complete your application.
- Only the chief investigator can initiate an application and complete the submission. However, other members of the research team can assist in completing the application form if they are added to the “contacts” list. You are encouraged to contact your statistician, legal advisor, health economist, clinical trial centre or equivalent early in the process and give them access to your application to complete their parts.
- A detailed budget should be submitted using the dedicated budget tool, for which separate guidance notes are available. It is recommended to complete the budget tool in collaboration with the clinical trial centre.
- All documents for the submission are listed below in the “Downloads” section.
- To be deemed valid and to enter the selection process, a submission should:
- Be written in English.
- Be submitted via the online submission platform (kce.smartsimple.ie) before the deadline.
- Include details of the chief investigator and candidate sponsor.
- For Belgian trials, include a signed sponsor support letter using the KCE Trials template or, for international trials with a non-Belgian sponsor, a support letter from the Belgian Coordinating Centre (BCC) and a commitment letter signed by the international sponsor, using the applicable KCE Trials templates. The letters must be signed by the legal representative of the sponsor/BCC (usually the CEO), or an official delegate.
- Include a study budget in the appropriate template.
- If there is any collaboration with a commercial partner (e.g. supply of free/discounted medication, apps, medical devices etc.), a signed commitment letter from the commercial partner accepting the KCE Trials terms and conditions using the applicable KCE template should be included in the initial submission. This will be used in order to assess the non-commercial nature of the trial and additional information may be requested. Standard purchasing under normal market conditions does not require a signed commitment letter.
Downloads
• Research application form including guidance (Word) version 1.0, 11 May 2026
• Template commitment letter party offering support (Word) version 3.0, 11 May 2026
• Patient involvement plan (Word) version 4.0, 12 May 2026
• Top ten tips and tricks for a successful research outline (pdf) version 4.0, 12 May 2026
Documents for studies with sponsor in Belgium:
• Budget tool (Excel) version 7.1, 8 May 2026 + guidance (pdf) version 7.1, 8 May 2026
• Template support letter candidate sponsor (Word) version 1.7, 11 May 2026
• Research agreement template Sponsor (Word) version 6.7, 12 June 2026
Documents for studies with international sponsor:
• Budget tool international trials (Excel) version 6.1, 8 May 2026 + guidance (pdf) version 6.1, 8 May 2026
• Template support letter Belgian coordinating centre (Word) version 1.6, 11 May 2026
• Template commitment letter international sponsor (Word) version 3.0, 09 May 2025
• Research agreement template BCC (Word) version 5.6, 12 June 2026
Template for second stage submission (Full Research Proposal):
• Intellectual property assessment template (Word) version 1.0, 12 May 2026
Template after study completion:
• End report containing the basic information for economic evaluation and implementation (word) version 1.0, 13 Jan 2026
Links
- Answers to frequently asked questions
- Resources for investigators (including protocol templates)
Contact and further information
Applicants have the opportunity to ask questions about this call and on their specific research project during the online information session on 4 June 2026, 10.00-12.00 AM (agenda).
To register for the information session or any other questions, contact us at trials[@]kce.fgov.be
