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 research into comparative effectiveness or repurposing of a drug. 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 work better in a real-life situation). Accepted study interventions are not limited to drugs or medical devices but also include a broad range of interventions for example psychotherapy, diet, life-style interventions, diagnostic tests, surgery or ways to deliver health care. In addition, repurposing trials using off-patent drugs are eligible for funding under certain conditions. 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 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 (established or not) of the same or 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 question 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 need help with the health economics part of my proposal?

If you need help with the health economics part of your trial or proposal, 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 on the phone 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 trial effectiveness results.  

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

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

You can use the (official) price listed on the RIZIV - INAMI website https://www.inami.fgov.be/ for the Research Outline. It is correct for most new medicines in Belgium (and abroad) the health insurances make volume-price deal with the company which is not made public.

In the economic evaluation that is performed after the clinical trial, the health economist can use several percentages of discount to take that variable in the health economic analysis.

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

Biomarker development can be part of the study if this is clearly needed to support the value for money aspect of the trial both from a patient and healthcare payer perspective. The candidate sponsor should provide a clear justification in its proposal. 

8. What is a non-commercial sponsor? Who qualifies as a non-commercial sponsor under the Belgian law?

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 section 5 of ICH-GCP. To qualify as a non-commercial experiment, the sponsor of a study should be one of the following (in summary, for more details, see law of May 7th, 2004):

  • A university or university hospital
  • A hospital (as defined in W 2013-03-19/03, art. 88, 012 or W 2015-12-26/03, art. 77)
  • The ‘Fonds National de la Recherche Scientifique’ or ‘Fonds voor Wetenschappelijk Onderzoek’ or a research organisation funded within their programs
  • A hospital department that qualifies as expert centre within their field (and recognised as such by royal decree)
  • An organisation that is recognised as non-commercial sponsor by royal decree after advice of the Belgian Advisory Committee on Bioethics of (Art.31 of the law of May 7th, 2004)

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 summarized several possibilities of how international trials can fit into the KCE Trials programme. 

Situation Route
The study has not started recruiting yet
I am the Sponsor-Chief Investigator (CI) and both the Sponsor and the majority of sites/patients are in Belgium (with a minority of sites/patients in other European countries) You can submit your trial proposal to any applicable open KCE call if your proposal complies with the call's criteria.
 
The Sponsor-CI is abroad and has contacted me to coordinate Belgian sites to participate in the study. The study preparation is well advanced and the sponsor has funding for the study. You can submit your trial proposal to any applicable open KCE call or to an International call if your proposal complies with the call's criteria.
 
The sponsor-CI is abroad and has contacted me to coordinate Belgian sites to participate in the study. The trial concept is at an early stage of development and the Sponsor has not got funding and/or each participating country will need to find funding for a portion of central tasks. You can submit your trial proposal to any applicable open KCE call if your proposal complies with the call's criteria.
 
The study is already recruiting abroad
The sponsor is abroad and has contacted me to coordinate Belgian sites to participate in the study. No KCE Trials funding stream is applicable for such situations.
 

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

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

If you don’t have a CTU 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 CTUs who may be willing to support and collaborate with you for your trial.

11. For supplements that are used and that are categorised as "drugs", do we need to apply for approval at FAMHP?

If the supplements are prescribed in routine practice and within the approved label, they are not considered as investigational medicinal product (IMP) for pragmatic trials. No approval from FAMHP will be required.

If the supplements are considered as IMP, they will have to follow the correct regulatory flow. Advice should be sought from FAMHP prior to development of the full research proposal.

In this stage we suggest to request advice at FAMHP to avoid any misunderstandings.

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 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 allowed under the same conditions only (no strings attached).

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

13. Is full monitoring necessary for the KCE trials or can you agree with risk based monitoring?

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. It would also be good to describe review or escalation plans, in case things need to be adjusted as requested by ICH-GCP E6 (R2).

14. 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.

Published on: 
18-11-2019