On 18th May 2021, the sixth KCE Trials national call for proposals on comparative effectiveness studies will open.
The KCE Trials programme 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 daily 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. In addition, repurposing trials using off-patent drugs are eligible for funding under certain conditions. Currently, 34 clinical trials are being funded in Belgium by this programme.
More detailed information on the scope of the 2021 call can be found below.
The 2021 call will be investigator-led (as for the previous 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 18th May 2021. Submissions should be done via the KCE Trials Research Manager Platform (https://kce.smartsimple.ie/).
The deadline for submission is 14th September 2021, 13:00.
Strengthening Workshop for interested applicants – June 7th from 3PM-5PM (session 1 on scope of the call, selection process and budget) and June 10th from 3PM-5PM (session 2 specific on the methodology of pragmatic trials and patient involvement).
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 these (optional) workshops. The first workshop will focus on the practical aspects of the proposal, while the second will focus on scientific/methodology aspects and patient involvement. They will provide tips to pre-empt the most frequent comments done on the proposals. 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 2nd June.
For more information, please contact trials”at”kce.fgov.be
Inclusion criteria for the 2021 call
The primary aim of the study should be non-commercial (see Belgian law of May 7, 2004 related to experiments on human person).
• The candidate sponsor should qualify as a non-commercial sponsor under the applicable laws, including the law of May 7, 2004 related to experiments on human person or equivalent e.g. if the sponsor is not located in Belgium.
• The holder of the intellectual property rights on the studied intervention or comparator 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 must comply with the European state aid regulations.
Comparative effectiveness studies
• The trial is a comparative effectiveness trial, comparing 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) 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.
• Studies on the effect of medical devices or on patent drugs are in scope, provided that there is a strong justification why the study would not be performed by the market authorisation holder, and provided there is a high return on investment expected.
Drug repurposing studies
• 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:
o The drug is off patent.
o There is a potential for high return on investment.
o There is substantial underlying evidence that supports moving to a large-scale confirmatory randomised trial.
• The trial is randomised (at individual level or in clusters) and multi-centric (with at least one recruiting centre in each region, unless there is a good justification not to do so).
Exclusion criteria for the 2021 call
• Studies for which 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. International studies that have already started abroad 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 study 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 market authorisation in Belgium are out of scope. 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 practice, outside the framework of research. Interventions that have been used only within the framework of clinical research are out of scope.
• Pilot studies are out of scope. There should be substantial underlying evidence that supports moving to a large-scale confirmatory randomised trial
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 widely 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.
Selection and prioritisation criteria for the 2021 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.
• The study budget is acceptable within the overall budget of KCE Trials.
We have observed that studies in older people are currently underrepresented in the KCE Trials portfolio. Therefore we would welcome proposals studying older people. However, this should not be considered a limitation of the accepted study populations or the scope of the call.
Footnote: No rights can be derived from this prior notice. The final call text and the conditions and criteria set forth therein will prevail.