Frequently Asked Questions (FAQ)

1. How to receive information on the KCE Trials programme?

We strongly encourage you to sign up to receive news from KCE Trials programme via this link to be kept informed on ongoing and upcoming activities. 

You will also find additional information on how to prepare a research Outline in the top 10 tips and tricks available on the KCE trials website.

2. Which trials are eligible for funding within the KCE Trials programme?

KCE Trials funds non-commercial comparative effectiveness or drug repurposing research. Development trials (innovation) and implementation research are not eligible for funding by KCE Trials. Comparative effectiveness trials compare the benefits and harms of different treatment options that are already in use in the health care system but which have never been adequately compared directly (i.e. which of 2 treatments works better in a real-life situation and is the most cost-effective). 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. 

You will find more information about how proposals are selected and the specific scope of our calls on the KCE website.

3. What is a pragmatic trial and why are they important for healthcare policy makers?

A trial is described as pragmatic when it is designed to test interventions in a way that the treatments are performed as closely as possible to the way they would be in normal clinical practice. This approach aims to maximise the applicability and generalisability of the results. The research question is whether an intervention actually works in real life and for the actual population it will be used to treat.
The intervention is evaluated against other ones of the same or a different class, in routine practice settings. The interventions that are compared can be medicinal products but also other interventions like diet, exercise, devices, operating techniques etc. Pragmatic trials measure a wide spectrum of outcomes, mostly patient-centred.
Policy makers have an active interest in pragmatic trials, since these are designed to answer the questions most relevant to a decision maker's agenda: the comparative effectiveness of interventions in routine practice. Along with the pragmatic trial, cost-effectiveness analyses can be designed that inform policy makers and health care providers.

4. How do I make my trial pragmatic?

Trials can be made pragmatic in several different ways and many different approaches should be used in any one trial. The key is to try to keep the trial setting as similar as the real-life setting, for example:

• Avoid restrictive inclusion and exclusion criteria, the trial population should be as close to the real-life population as possible (i.e. only patients who could not receive the treatment in standard of care should be excluded from the trial).
• Depending on your trial design and if the study intervention is a medicine, it should be provided in the same way as it would in standard of care e.g. by prescription collected from community pharmacy if this is what would happen in standard care.
• The tests and scales used to select patients or to follow the disease should be the tests and scales used in standard practice, as much as possible.
• Question every variable that will be collected for relevance with regard to the objective of the trial. E.g. in pragmatic trials, the studied interventions are typically very well documented for safety. Consequently, variables should not copy/paste variables from phase II and III protocols.

 You can find more information about pragmatic trials on the KCE Trials website under the resource section.

5. What do I do if I have questions about the health economics part of my proposal?

Please read carefully the instructions on the application form and guidance of the call. If you still have any questions, please contact KCE Trials (trials[at]kce.fgov.be) as they can put you in contact with a KCE Health Economist. Please prepare yourself to present your trial outline and discuss the health economic variables that will be collected to allow for a possible health economic analysis. The decision to conduct health-economic modelling will however depend on the effectiveness results of the trial.  

You can find more information about Health economics in the resource webpage of the KCE website.

6. In the Research Outline you are requested to provide us with the price and reimbursement status of the intervention.  Agreements regarding the price of drugs between the Marketing Authorization Holder and RIZIV/INAMI are not available to the public. Therefore, how do we deal with that? The price is important information when conducting a comparative effectiveness study. 

You can use the (official) price listed on the RIZIV - INAMI website for the Research Outline.

It is correct that for most new medicines in Belgium (and abroad) the health insurance makes a volume-price deal with the company that is not made public. In the economic evaluation that is performed after the clinical trial, the health economist should in this case use several percentages of discount to include that variable in the health economic analysis.

7. Can the cost for biomarker development be included in KCE trials proposals?

Biomarker development cannot be part of the study budget. If associated translational research is planned, additional funding sources must be found. However, all data are subject to the terms and conditions of the KCE-Sponsor agreement.

8. Who can act as sponsor of a KCE funded trial?

The sponsor of a clinical trial is the person or organisation who takes responsibility for the initiation and management of the trial, as defined in the applicable laws and in internationally recognised ethical and scientific quality requirements such as ICH-GCP E6 or ISO 14.155 guidelines.

The candidate sponsor (and the Belgian Coordinating Centre, if applicable) should be a non-profit organisation or institution that can function as sponsor of non-commercial multicentre trials and has the ability to comply with all sponsor related obligations. Furthermore:

• The sponsor or the BCC are not the holders of the intellectual property rights (e.g. patent on a medicinal product or registered trade mark for a medical device) on the products or invention to which the experiment relates.
• The candidate sponsor and the research team have no conflict of interest with regard to the conduct and possible results of the trial.
• The sponsor exercises the intellectual property rights to the concept of the trial, its implementation and the scientific data resulting from it.
• The funding granted under the research agreement complies with the European state aid regulations.

9. Can I submit an International study to KCE?

KCE Trials funds Belgian participation to international trials in several ways. In the table below, we summarise several possibilities of how international trials can fit into the KCE Trials programme. 

You will find more information about how proposals are selected on the KCE website.

10. What do I do if I don’t know a Clinical Trial Centre (CTC) or don’t have a CTC to act as sponsor for my proposed trial?

If you don’t have a CTC to collaborate with for your trial, you can contact KCE Trials (trials[at]kce.fgov.be) and we will put you in contact with candidate CTCs who may be willing to support and collaborate with you for your trial.

11. Is co-sponsorship possible for KCE Trials proposals?

Co-sponsorship could be possible for KCE Trials proposals, including in case of international trials. Feel free to contact KCE Trials (trials[at]kce.fgov.be) to discuss your particular situation.

12. Is it possible to commercialise discoveries resulting from studies funded by the KCE Trials programme? Is industry involvement allowed in KCE Trials?

The primary aim of the study should be non-commercial. The candidate sponsor should therefore understand our key requirements regarding the use and exploitation of the study data and carefully read the sections in the template research agreement that deal with commercialisation. Industry involvement, e.g. by providing free placebo or free products is only allowed when it does not conflict with these sections (e.g. unconditional educational grants).

You can find the Research Agreement template on the KCE trials website under the call specific documents.

13. Are studies involving apps funded?

There are 2 possible situations when an app may be used in a study:

A: when the app is only used to collect outcome data. In this case the app is not part of the intervention and will not be used after the study is completed. As long as the app is already validated and complies with all regulatory and data protection requirements then this is acceptable.

B: when the app is part of the intervention. In this case 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. All other scope requirements also have to be met for example that the app is already being in use in daily practice in Belgium. 

14. Is full monitoring necessary for KCE trials or can risk based monitoring be acceptable?

Risk based monitoring is appropriate for KCE Trials. You will just need to describe what type of monitoring is planned and justify the level chosen. The monitoring of a low-interventional, low-risk, pragmatic trial will require less frequent on-site monitoring visits and can even be done completely centralised. It is important to develop a monitoring plan as soon as possible to determine the monitoring requirements and frequency for the specific trial. It is recommended to describe review or escalation plans, in case things need to be adjusted as described by the latest approved versions of the ICH-GCP or ISO14155 guidelines.

15. Are more calls planned?

KCE Trials aims to open at least one call per year. What type of call may be launched will depend on previous calls and the needs of healthcare payers.

All closed, open and future calls information can be found here.