On 6th June 2019, a fourth KCE Trials call for proposals will open
The KCE Trials programme mainly 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. Currently, 14 clinical trials are being funded in Belgium by the programme.
More detailed information on the scope of the 2019 call can be found below.
The 2019 call will be investigator-led (as for the 2017 and 2018 calls), meaning that investigators who submit a research proposal outline should have the support of a non-commercial sponsor to perform the 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 a) the non-commercial nature of the trial and b) data sharing policy.
Only multi-centre studies will be accepted. Participating centres should include at least one centre from each region (Flanders, Brussels, Wallonia), unless there is a good justification not to do so.
The call will open on 6th June 2019. Submissions should be done via the KCE Trials Research Manager Platform (https://kce.smartsimple.ie/).
The deadline for submission is 17th September 2019, 13.00.
Strengthening Workshop for interested applicants – 13th June 13.00 - 17.00
To receive more information on the scope of the call and specificities of the KCE Trials Programme, all possible applicants are invited to participate to this (optional) afternoon workshop (in the previous calls, this workshop was only accessible to applicants who passed the first selection of step). The workshop will combine sessions on scientific and practical aspects of proposal development, and provide tips to pre-empt the most frequent comments from the Trials Board. There will be ample time for Q&A however please note that the focus is not individual feedback on a specific proposal.
The agenda of the strengthening workshop can be found here. Registration in advance is mandatory before Wednesday 29th May. We may need to limit the number of participants per team if necessary.
For more information, please contact trials"at"kce.fgov.be
- 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 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
- 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.
- 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 thus 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.
Selection and prioritisation criteria for the 2019 call
Study proposals will be prioritised based on the need for evidence in clinical practice and possible efficiency improvement 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, and/or the expected effect of the intervention is large.
- Funding by the commercial stakeholders is unlikely and/or not warranted.
- The geographical spread of the participating centres is well balanced over the different regions.
- The research question has been put forward as a priority by patient groups.
- The overall portfolio of the KCE Trials programme remains well balanced in terms of diseases areas, types of interventions and settings.
Footnote: No rights can be derived from this prior notice. The final call text and the conditions and criteria set forth therein will prevail.