Frequently Asked Questions (FAQ)

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

KCE Trials funds research into comparative effectiveness. 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.

2. 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.

3. 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. The Belgian law includes specific exemptions for non-commercial studies. 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)

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

The candidate sponsor should carefully read the sections in the template research agreement that deal with commercialisation. KCE has a say in the conditions under which a product based on the study is commercialised, e.g. a reasonable price for the product (e.g. biomarker) when it comes to the market; this clause is fully supported by the KCE board. Industry involvement, e.g. by providing free placebo or free products, is allowed under the same conditions only (no strings attached).

5. 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.

6. 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 patient 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.

This NEJM paper gives more information on pragmatic trials: http://www.nejm.org/doi/full/10.1056/NEJMra1510059

KCE Trials organises regular training on methodological and regulatory issues related to pragmatic clinical trials, for health care providers, patients and the public and researchers with limited or advanced experience. Want to know more? Subscribe to the KCE Trials mailing list.

7. 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.  

8. 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 or to an International call if the participating countries/sites comply with the calls 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 the participating countries/sites comply with the calls 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 or to an International call if the participating countries/sites comply with the calls 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 standard KCE Trials funding stream is applicable for such situations. Exceptionally, the Prioritisation Group can decide to approve a limited type of funding for the participation of Belgian sites, as was the case for specific ongoing trials funded by ZonMw and for which Belgian sites were requested to participate.
 

9. I heard KCE Trials is organising some training courses for investigators who are keen to submit proposals to their calls. How can I find out more information about these course and how to apply to attend?

If you would like to attend courses designed to support clinical trialists please contact KCE Trials and they will give you more information. Examples of courses run or planned include; health economics and what data to collect in clinical trials, patient and public involvement in clinical trials, pragmatic trial design, trial design and stats for studies,  trial budget development and management, IT tools for clinical trials.

10. Are more calls planned? Commissioned, investigator-led, international?

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. KCE Trials will join international calls when considered of relevance to meet its objectives. Calls to open in the near future are announced here. Calls that are currently open can be found here.

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

Published on: 
2017/10/30