Investigator-led call 2018

On 5th June 2018, a third KCE Trials call for studies will open

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, surgery or ways to deliver health care.

This call will be investigator-led, meaning that investigators who submit a research proposal outline should have the support of a non-commercial sponsor. Preferably, trials are conducted with the assistance of a clinical trial unit or equivalent.

Participation of Belgian centres to an international trial within the scope of this call, is also eligible for funding.

Inclusion criteria for the 2018 call

Comparative effectiveness

The trial is a comparative effectiveness trial, comparing two interventions (including no treatment) that are already in use in Belgium in a given indication. Medications used off-label in daily practice is considered in scope.

Repurposing of drugs for a 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 randomized 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 conform with the European state aid rules and regulations.

Exclusion criteria for the 2018 call

Implementation studies

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 see above. Software and apps should be developed and piloted. Also interventions related to organisation of care should already be in use in daily practice. All types of interventions should already be in use in practice, outside the framework of research.

Started studies

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.