2025 - KCE Trials 2025 investigator-led call

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. Accepted study interventions for treatment or prevention include a wide range of healthcare interventions, such as drugs, medical devices, surgery, physiotherapy, psychotherapy, lifestyle changes, diagnostic tests or complex interventions with several components. Study settings can vary from highly specialized hospital care to primary care. All trials are randomised and require a multicentric setting.

Two types of studies are funded :

Comparative effectiveness studies comparing two treatment options that are already used in clinical practice for a given indication, but have not yet been sufficiently directly compared (i.e. which of the two treatment options works best in daily practice and is the most cost-effective).
Drug repurposing studies investigating a new indication for an off-patent drug.

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. This document describes the criteria for participation and selection for the 2025 investigator-led call. The budget available for this call is € 8.0 million with the aim of funding 4-6 studies.

Scope
Inclusion criteria

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.
They are not the holders of existing intellectual property rights (e.g. patent on a medicinal product or registered trade mark for a medical device) on the products or invention to which the experiment relates.
The candidate sponsor and 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.
If there is a potential commercial interest in the trial (e.g. the trial requires the use of drugs, apps or medical devices), an exclusivity criterion comes into play. In general, the results of the trial cannot bring an exclusive benefit to a single company only.
Studies on the effect of medical devices, tools (including software and apps) or on-patent drugs are only in scope, provided that there is a strong justification why the study would not be performed by the marketing authorisation holder or manufacturer. In this situation an expected high return on investment is required.
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).
There is substantial underlying peer-reviewed evidence that supports moving to a large-scale confirmatory randomised trial.

Additional inclusion criteria for comparative effectiveness studies

The trial compares two therapeutic or diagnostic interventions (no treatment/no test can also be an option) that are already in use in daily practice in Belgium in the studied indication.
Medication used off-label in daily practice is considered in scope.
Studying an intervention that is already in use in a patient group (e.g. adults) in another patient group, (e.g.; children, elderly, oldest old) can be considered in scope. A change of timing, e.g. first line versus second line, or change in dosing or duration of the treatment can also be considered in scope.

Additional inclusion criteria for drug repurposing studies

The available evidence suggests that there is a potential for high return on investment.
The drug is authorised and effectively commercialised in Belgium (or in use in daily practice in Belgium).
The drug is off-patent. The applicant will have to demonstrate at a later stage in the selection process that there is no intellectual property issue (e.g. secondary patents).

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.

Implementation studies and quality improvement studies

If the primary aim of the studied intervention is to promote the uptake of research findings, the trial is considered implementation research, which is out of scope. Interventions that aim to improve implementation of existing guidelines, health policies, programmes and practices are also out of scope, as are studies that aim to improve quality of care.

Development and innovation studies.

Drugs without marketing authorisation in Belgium are out of scope except if already widely used in Belgium.
Medical devices without a CE label are out of scope.
All types of interventions, including interventions related to organisation of care, should already be in use in daily practice. Interventions that have been used only within the framework of clinical research or pilot testing are out of scope.
Proof of concept studies are out of scope.

Mobile health studies (apps)

Software and apps used as part of the intervention that are not fully developed, piloted and that do not meet all regulatory requirements on data protection are out of scope. Apps that are not used in daily practice in Belgium are also out of scope.
Study proposals on software and apps should also include an implementation plan which is in agreement with the non-commercial aim of the KCE Trials programme. Proposals without this implementation plan will be considered 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 investigator-led 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.
Who can submit to the 2025 investigator-led 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 primarily 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 20th May 2025 until 13h on 23rd September 2025.
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 detailed below in the “Downloads” section.
To be deemed valid and to enter the selection process, a submission should:
o    Be written in English.
o    Be submitted via the online submission platform (kce.smartsimple.ie) before the deadline.
o    Include details of the chief investigator and candidate sponsor.
o    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.
o    Include a study budget in the appropriate template.
o    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