KCE Trials 2020 investigator-led call

Important information

The online submission platform is now available for submissions.

Please follow the link: http://kce.smartsimple.ie

To be able to submit, you have to create an account. 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 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’d 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.

If you experience any problems with creating an account or submitting your project, please contact us at trials”at”kce.fgov.be.

Deadline for submissions: 15th September 2020, 13.00

Background

Many questions in healthcare are currently not or 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, etc. KCE concluded in the summer of 2015 that public funding of such trials would be beneficial (Report 246-2015) under certain conditions. These trials not only contribute to better patient care but also to a more efficient use of public resources.

The KCE Trials programme, including the 2020 call, focuses on comparative effectiveness trials which show clear value for money and have the potential for return on investment. Those 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). Accepted study interventions are not limited to drugs or medical devices but also include a broad range of interventions for example psychotherapy, diet, diagnostic tests, surgery or ways to deliver health care. In addition, repurposing trials using off-patent drugs are eligible for funding under certain conditions.

Scope

Inclusion criteria

Comparative effectiveness

  • The trial is a comparative effectiveness trial, comparing two interventions (no treatment/no test can also be an option) that are already in use 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.

Repurposing

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 of high return on investment.
  • There is substantial underlying evidence that supports moving to a large-scale confirmatory randomised trial.

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 an experiment, its implementation and the scientific data resulting from it.
  • The agreement must comply with the European state aid rules and regulations.

Exclusion criteria for the 2020 call

Started studies

  • 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.

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 guidelines or quality of care are also out of scope.

Development and innovation studies

  • Drugs and devices should have market authorisation in Belgium (devices should have a CE label).
  • 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.
  • All types of interventions, including interventions related to organisation of care, should already be in use in practice, outside the framework of research. Interventions that have been used only within the framework of clinical research or pilot testing are out of scope.

For more details on the selection criteria, please read the call text.

Deadline

15th September 2020, 13.00

Who can submit

This call is for investigator-led trials, meaning that investigators who submit a research proposal outline should have the support of a non-commercial sponsor to perform the proposed clinical trial. It is strongly recommended that trials are developed and conducted with the assistance of a clinical trial unit or equivalent.

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.

Call text

You can find the complete call text here.

Downloads (all documents Call 2020)

Call text 2020 V1.1 (pdf) and Timelines 2020 V1.0 (pdf)

Application form (including guidance notes) V1.1 (Word) 

Budget tool V5.0 (Excel) and accompanying guidance notes V5.0 (pdf)

Template support letter candidate sponsor V1.1 (Word)

Research agreement template V4.0 (Word)

Protocol template for Full Research Proposal V2.0 (Word)

FAMHP statement on the non-commercial status of trials funded under the KCE Trials programme (2004 law), to be added to submission to FAMHP where applicable (pdf)

Top ten tips and tricks for a successful research outline V3.0 (pdf)

Documents for trials with international sponsor

Budget tool for international trials v4.0 (Excel) and accompanying guidance notes v4.0 (pdf)

Template support letter Belgian coordinating centre international trials V1.1 (Word)

Template letter of commitment international sponsor V2.1 (Word)

Research agreement Belgian coordinating centre template V3.0 (Word)

Presentations from Strengthening Workshop (Call 2020) – 4th June 2020

Agenda

Scope of KCE Trials Programme (Frank Hulstaert - KCE)

Selection Process (Jilly Harrison & Lisa Marynen - KCE)

Sponsor responsibilities in GCP (Nelle Stocquart - KCE)

Trial budget (Hilde Nevens - KCE)

Pragmatic trials (Leen Verleye - KCE)

Public and patient involvement (Isabelle Manneh - guest speaker)

Sample size (France Vrijens - KCE)

Health economics (Mattias Neyt - KCE)

Links

Answers to frequently asked questions

Resources for investigators

Contact and further information

For any questions, contact us at trials[@]kce.fgov.be

 

Published on: 
2020/07/09