This call closed on 15th April, 2021
Update 14 January 2021 (v2) : Non-commercial vaccine trials have been added to the scope (more information below).
Background
In response of the urgent need for clinical research into COVID-19, KCE Trials is organising a rolling call for proposals for COVID-19 clinical trials, using a fast-track procedure for selection (4 weeks after submission). The call is for rapid response proposals i.e. studies that should be up and running within the next months. It is a rolling call, meaning that the selection process starts upon submission and that there is no fixed closing date (the tentative closing date of the call is currently April 15th 2021. The existing KCE Trials selection process is adapted and simplified to be used to select, fund and follow-up ‘rapid response’ COVID studies. The high-level process can be found below.
This fast-track COVID-19 rolling call focuses on non-commercial multi-centre randomised interventional (therapeutic, preventative or diagnostic intervention) trials, where there is a high and urgent need for generating evidence for COVID-19 patients, and where there is substantial underlying evidence that supports performing a large-scale confirmatory randomised trial. Typical examples of trials in scope are drug repurposing studies of old (off patent) medication that could help treat COVID-19. Trials including newer drugs (on patent and already on the market) are also in scope, provided the Sponsor has a strong justification why the study should/would not be performed by the market authorisation holder. Trials on drugs still in development are out of scope. Interventions are not limited to drugs and devices, diagnostic trials with clinically relevant endpoints for the management of COVID-19 are also in scope, as are interventions related to the rehabilitation of COVID-19 patients.
Non-commercial single centre or multicentre trials on covid-19 vaccination are in scope provided they support the Belgian taskforce “operationalisering COVID-19-vaccinatiestrategie/opérationnalisation de la stratégie de vaccination COVID-19” and are set-up in collaboration with Sciensano and the FAMPH. Where possible and appropriate, international collaboration is preferred. The KCE Trials focus and expertise is on the funding of randomised trials. Non-randomised study designs are generally coordinated through Sciensano.
The aim of the study cannot be commercial, and the sponsor should be a non-commercial sponsor, in Belgium or abroad (in that case KCE Trials funds the coordination of the study in Belgium for the participation of Belgian centres).
The funding of trials selected in this fast-track rolling call will not originate from the usual KCE Trials Programme budget, but will be decided on a case by case basis and will require specific approvals from the Federal Minister of Budget. The prolongation of this call is conditional to the availability of funding.
Scope
Inclusion criteria
Aim of the study
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 the experiment, its implementation and the scientific data resulting from it.
- The agreement must comply with the European state aid rules and regulations.
Design
- The trial is randomised (individual or cluster) and multi-centric (with ideally at least one recruiting centre in each region). Single centre studies may be accepted if there is a strong argumentation against a multi-centre trial.
Intervention
- The trial compares two (or more) interventions (vaccine, drug, medical device, other intervention. No treatment/test as comparator can be an option) with the aim of treating or diagnosing COVID-19 patients.
- Drugs and devices should have market authorisation in Europe, the US or Japan (if the drug/device is not on the market in Belgium, the applicant has to explain how it will be made available to Belgian patients after the study).
- Diagnostic trials with clinically relevant endpoints for the management of COVID-19 are also in scope.
Specifically for trials where the intervention is an Investigational Medicinal Product (IMP),
- Studies on the effect of off patent drugs on COVID-19 are in scope (drug repurposing studies, for drugs used off label), provided there is substantial underlying evidence that supports moving to a large-scale confirmatory randomised trial.
- Studies on the effect of on patent drugs on COVID-19 (used off label) are in scope, provided that there is a strong justification why the study should/would not be performed by the market authorisation holder, and provided there is a high return on investment.
Exclusion criteria for the fast-track COVID-19 rolling call
Ongoing/ already started studies are out of scope
- 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. There may be exceptions to this rule for international studies that have already started in other countries (to be discussed case by case).
Implementation studies and quality improvement studies 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 also 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.
Development and innovation studies are out of scope
- Drugs and devices without market authorisation (Europe, or US, or Japan) are excluded.
- Devices without CE label are excluded.
- Software and apps used as part of the intervention should be fully developed, piloted and meet all regulatory requirements on data protection. 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.
For more details on the selection criteria, please read the call text.
Closing date
This is a rolling call, meaning the selection process will start upon your submission and there is no fixed closing date.
Tentative closing date: 15th April 2021, 13.00
If the closure date is not 15th April, information on the closure date will be posted here on the KCE website by this date and at least 2 weeks before closure.
Who can submit
This call will be investigator-led, meaning that investigators who submit a research proposal 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 unless there is a good justification not to do so. Participating centres should include at least one centre from each region (Flanders, Brussels, Wallonia), unless there is a good justification not to do so. In order to support collaboration between centres and avoid duplication of research efforts, at least all academic hospitals (or academic centres for general practice or relevant public health institutes) in Belgium should be informed about the study proposal and invited to participate.
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 (see below). A signed letter of support by the Belgian coordinating centre, using the KCE Trials templates, should also be included in the submission.
How to submit
All submissions should be done through the online submission platform http://kce.smartsimple.ie/.
To be able to submit, an account has to be created. Please create this account as soon as possible to enable us to correct possible problems. 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 would 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.
