Many questions in healthcare are currently not or not sufficiently studied in clinical trials, despite their high societal importance, e.g. comparison between medication and surgery, between different surgical techniques, between lifestyle changes and a medical intervention, etc. KCE concluded in the summer of 2015 that public funding of such trials would be beneficial (Report 246-2015) under certain conditions. These trials not only contribute to better patient care but also to a more efficient use of public resources.
The KCE Trials programme, including the 2018 call, focuses on comparative effectiveness trials which show clear value for money and have the potential for return on investment. 'Comparative effectiveness ' studies compare two treatment options (including no treatment) that are already in use in clinical practice in a given indication, but are not yet sufficiently directly compared (i.e. which of the two treatment options work best in daily practice). Accepted study interventions are not limited to drugs or medical devices but also include a broad range of interventions for example psychotherapy, diet, diagnostic tests or surgery.
- The trial is a comparative effectiveness trial, comparing two interventions (including no treatment) that are already in use in Belgium in a given indication. Medication used off-label in daily practice is considered in scope.
- Repurposing of drugs for an intervention for which it is currently not used in daily practice may be in scope if the following 3 conditions are met:
- The drug is off patent.
- There is a potential of high return on investment.
- There is substantial underlying evidence that supports moving to a large-scale confirmatory randomised trial.
The primary aim of the study should be non-commercial (see Belgian law of May 7, 2004).
- The candidate sponsor should qualify as non-commercial sponsor under the applicable laws, including the law of May 7, 2004 or equivalent e.g. if the sponsor is not located in Belgium.
- The holder of the patent of a medicinal product or of a registered trademark of a medical device to which the experiments relate is neither directly nor indirectly the sponsor of the experiment.
- The sponsor exercises the intellectual property rights to the concept of an experiment, its implementation and the scientific data resulting from it.
- The agreement should be in line with the European state aid rules and regulations.
Exclusion criteria for the 2018 call
- Implementation Research, defined as “the scientific study of methods to promote the uptake of research findings in practice”. Interventions that aim to improve implementation of guidelines or quality of care are out of scope.
Development and innovation studies.
- Drugs and devices should have market authorisation in Belgium; for off-label use and repurposing the conditions are set out above (see inclusion criteria). Software and apps used as part of the intervention should be fully developed and piloted. All types of interventions including interventions related to organisation of care, should already be in use in practice, outside the framework of research.
- Studies where recruitment has already started, or which have already been submitted to an ethics committee or to the FAMHP (Federal Agency for Medicines and Health products) are out of scope.
For more details on the selection criteria, please read the call text.
25th September 2018 13.00h
Who can submit
This call is for investigator-led trials, meaning that investigators who submit a research proposal outline should have the support of a non-commercial sponsor to perform the proposed clinical trial. Preferably, trials are conducted with the assistance of a clinical trial unit or equivalent.
Participation of Belgian centres to an international non-commercial trial within the scope of this call, is also eligible for funding. In that case, the sponsor of the international trial should sign a commitment letter, confirming acceptance of the KCE Trials terms and conditions regarding the non-commercial nature of the trial and data sharing.
You can find the complete call text here.
Links & Downloads
Contact and further information
For further information on the KCE Trials programme and the 2018 investigator-led call, please consult the KCE website https://www.kce.fgov.be/.
For any questions, contact us at trials[@]kce.fgov.be