KCE Trials 2025 investigator-led call

Il est obligatoire de prendre contact avec le grant management de l'H.U.B avant la deadline interne afin de postuler : Grants.DCR.HUB@hubruxelles.be

La création d'un profil utilisateur et l'accès au dossier complet pour la soumission d'un projet se fait ici : https://kce.smartsimple.ie/s_Login.jsp

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. 

Prioritisation criteria

Study proposals will be prioritised based on the need for evidence in clinical practice and possible efficiency gain for the Belgian health care system.

Other criteria will be taken into account during the prioritisation process:

• The number of people potentially impacted by the intervention is large. For rare indications, international trials are preferred.

• The expected effect of the intervention/improvement is large (mandatory if the previous criterium is not met).

• Funding of the study by commercial stakeholders is unlikely and/or not warranted.

• The geographical distribution of the participating centres is well balanced across the different regions.

• The research question has been put forward as a priority by patient groups or is ranked high on a research agenda developed in collaboration with patients.

• The overall portfolio of the KCE Trials programme remains well balanced in terms of diseases areas, types of interventions and settings.

• The trial budget is justifiable and commensurate with the work involved and is acceptable within the overall KCE Trials budget. A good return on investment expected.

Finally, proposals aimed at improving mental health and proposals investigating treatments specifically supporting older people (as they are generally underrepresented in trials) would be welcomed. However, this should not be considered as a limitation of the accepted trial populations or the scope of the call.