Background
Addiction to legal and illegal psychoactive substances and other addictions are an important public health issue, with substantial health and social consequences or risks, including for the individual and its environment. To address these issues, a multiannual interfederal drug policy strategy has been approved recently by 26 Ministers. The federal government has also initiated several projects in various sectors. Availability of, and access to quality care and treatment services - without being stigmatised or facing discrimination – are crucial in this regard. In addition to ongoing initiatives, KCE Trials launches a call for study proposals addressing clinical research questions in this area.
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, including participants from each region in Belgium.
Scope
Within the domain of care for addiction, 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.
For inclusion, exclusion and prioritisation criteria, please visit the webpage of the 2026 comparative effectiveness call or the 2026 drug repurposing call
Who can submit to the 2026 themed call on care for addiction?
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:
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. Depending on your study type, you will need to submit your application to either the 2026 comparative effectiveness call or the 2026 drug repurposing call on the submission platform. In the application form, you will be able to indicate that your study proposal fits within this 2026 themed call on care for addiction.
- 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 of the 2026 comparative effectiveness call or the 2026 drug repurposing call.
- 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.
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
