2019 - KCE Trials 2019 investigator-led call

Background

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 2019 call, focuses on comparative effectiveness trials which show clear value for money and have the potential for return on investment. Those studies compare two treatment options (with ‘no treatment’ being one of the possible treatment options) 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. In addition, repurposing trials using off-patent drugs are eligible for funding under certain conditions.

Scope

Inclusion criteria

Comparative effectiveness

The trial is a comparative effectiveness trial, comparing two interventions (no treatment can also be an option) that are already in use in Belgium in a given 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) is considered in scope. A change of timing, e.g. first line versus second line, or change in dosing or duration of the treatment are considered in scope.

Repurposing

Repurposing of a drug(s) for an indication 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 for 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 a 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 on a medicinal product or of a registered trademark for a medical device to which the experiment relates is neither directly nor indirectly the sponsor of the experiment.
The sponsor exercises the intellectual property rights to the concept of the 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 2019 call

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.

Implementation studies

If the primary aim of the studied intervention is to promote the uptake of research findings, the study is considered implementation research, which is out of scope. Interventions that aim to improve implementation of guidelines or quality of care are also 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. Commercial software and apps should be CE labelled and meet the level II criteria as defined by mhealth Belgium.
All types of interventions including interventions related to organisation of care, should already be in use in practice, outside the framework of research. Interventions that have been used only within the framework of clinical research are out of scope.

For more details on the selection criteria, please read the call text.

Deadline

17th September 2019, 13.00

The KCE Trials 2019 Investigator-led call is now closed for submissions.

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.

How to submit

The online submission platform is now available for submissions.

Please follow the link: http://kce.smartsimple.ie

To be able to submit, you have to create an account. Please create an account as soon as possible and at least 48h before the submission deadline to enable us to correct possible problems with the online submission platform.

Once you have created the account, you can find information to start your submission under the “funding opportunities” tab. You might find it useful to have your completed application form to hand. You can then copy and paste from the completed application form straight into the appropriate fields in the tool.

Although the chief investigator is the only person who can start and submit a new submission we’d like to inform you that there is a possibility within the tool to invite colleagues to work on the submission with you. We recommend you to invite a member of your CTU/sponsor representative to collaborate so that they can add the sponsor support letter.

If you experience any problems with creating an account or submitting your project, please contact us at trials”at”kce.fgov.be.