Background
This call closed on 14th September 2021
Many questions in healthcare are currently 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, or questions addressing the needs of older people). 'Comparative effectiveness' 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). Since 2015, KCE is managing a national funding programme of such pragmatic practice-oriented clinical trials, the KCE Trials Programme. The annual budget is 9.5 € Million. To date, 34 clinical trials have been selected within this programme (see funded trials for more information on these trials or our dynamic dashboards for progress in recruitment).
This 2021 investigator-led call is the 6th national call of KCE Trials on comparative effectiveness (see calls for more information on other past and present calls). The trials should contribute to better patient care, should show clear value for money and should have the potential for return on investment. Accepted study interventions are not limited to drugs or medical devices but also include a broad range of interventions for example psychotherapy, physiotherapy, diets, diagnostic tests or surgery. In addition, repurposing trials using off-patent drugs are eligible for funding under certain conditions.
Scope
Inclusion criteria
The primary aim of the study is non-commercial (see Belgian law on experiments on human persons of May 7, 2004).
- The candidate sponsor (and the BCC, if applicable) qualifies as a non-commercial sponsor under the applicable laws, including the law of May 7, 2004 related to experiments on human persons, or equivalent 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 funding granted under the research agreement complies with the European state aid regulations.
Design
- 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).
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 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 also considered in scope.
- Studies on the effect of medical devices, tools or on patent drugs are in scope, provided that there is a strong justification why the study would not be performed by the marketing authorisation holder or manufacturer, and provided there is a high return on investment expected.
Drug repurposing studies
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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.
Exclusion criteria for the 2021 call
Started studies
- Studies for which recruitment has already started in Belgium, or which have already been submitted to a Belgian ethics committee or to the FAMHP (Federal Agency for Medicines and Health products) are out of scope. International studies that have already started abroad (but not in Belgium) 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 marketing authorisation in Belgium are out of scope except if used already in Belgium. 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 or development. Interventions that have been used only within the framework of clinical research or pilot testing are out of scope.
- Proof of concept 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 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.
Who can submit to the 2021 investigator-led call?
This call is investigator-led, meaning that investigators who submit a research outline should have the support of a non-commercial sponsor to perform the trial. It is strongly recommended that trials are developed and conducted with the assistance of a clinical trial unit or equivalent. Only multi-centre studies are eligible, with participating centres including at least one recruiting centre from each region (Flanders, Brussels, Wallonia), unless there is a good justification not to do so. Also trials run in the first-line setting, for example in general practice, should have participating investigators in the three regions.
Participation of Belgian centres to an international non-commercial trial within the scope of this call, is also eligible for funding.
The aim of the study cannot be commercial, and the sponsor should be a non-commercial sponsor, in Belgium or abroad. In this case, KCE Trials will provide funding for the participation of Belgian centres through a Belgian coordinating centre (BCC).
A letter of support, using the template provided by KCE Trials, signed by the candidate sponsor confirming acceptance of the trial sponsor obligations and acceptance of the terms and conditions included in the template KCE-sponsor research agreement should be included in the submission. The Belgian candidate sponsor or the BCC should qualify as non-commercial sponsor under the applicable laws, including the law of May 7, 2004 related to experiments on human person. If the sponsor is located abroad, a signed commitment letter by the international sponsor confirming acceptance of the KCE Trials terms and conditions regarding the non-commercial nature of the trial and data sharing conditions (see below) and a signed letter of support by the BCC, both using the KCE Trials templates, should be included.
For international trials with a Belgian sponsor and with more than 10% of patients recruited abroad, participation of other funders in the sponsor and site costs will be required.
How to submit ?
- The call will be open to submissions from 18th May 2021 until 13h on 14th September 2021.
- As a first step, candidates are asked to submit a research outline. Shortlisted candidates will be invited to submit a full research proposal (FRP) (with the study protocol) at a later stage.
- We suggest to contact KCE Trials (trials”at”kce.fgov.be) in advance if you want to resubmit a proposal that was not selected in a previous call.
- All submissions must be done using the KCE Trials online submission platform. To be able to submit, you have to create an account, if not yet done so. Please create an account as soon as possible and at least 1 week 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 may prefer to prepare your application using the application form in Word format, which is available below (section Downloads for your convenience, no application submitted in the word template will be accepted). This document also contains guidance on how to complete your application.
- Only the chief investigator can start an application and complete the submission. However, other members of the research team can help completing the application form if added to the contacts list. You are encouraged to contact your legal advisor, clinical trial unit or equivalent early in the process and give them also access to your application.
- A detailed budget should be submitted using the dedicated budget tool, for which separate guidance notes are also available. It is advisable to complete the budget tool in collaboration with the clinical trial unit.
- All documents for the submission are detailed below in the “Links & downloads” section.
- To be deemed valid and to enter the selection process, a submission should:
- Be written in English.
- Be submitted through the online submission platform before the deadline.
- Include details of chief investigator and candidate sponsor.
- Include a sponsor support letter using the KCE Trials template or, for international trials with a non-Belgian sponsor, a support letter from the Belgian coordinating centre and a commitment letter signed by the international sponsor, using the applicable KCE Trials templates.
- If there is any collaboration with a commercial partner (e.g. delivery of free/discounted medication, apps, medical devices etc.), a signed commitment letter from the commercial partner accepting the KCE Trials terms and conditions using the applicable KCE template or the contract should be included in the initial submission in order to assess the non-commercial nature of the trial. Simple purchasing on normal market condition does not require this signed commitment letter.
- Include a clearly defined research question in the PICO format (Patients, Intervention, Comparator, Outcome).
