2017 - KCE Trials 2017 Investigator-led call

KCE TRIALS 2017 INVESTIGATOR-LED CALL

KCE Trials is a programme of publicly funded pragmatic practice-oriented clinical trials.

On January 18th, 2017, a second call for studies has opened. 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 (clinical trial unit) to perform the proposed clinical trial.

The KCE Trials 2017 Investigator-led call is now closed for submissions.

The 2017 investigator-led call focuses on comparative effectiveness trials which show clear value for money and have the potential for return on investment. 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.

Study proposals will be selected based on the need for evidence in clinical practice and possible efficiency improvement for the Belgian health care system. Trials can lead to increased efficiency of the health care system in addition to benefit for patients in the following ways:

If positive, the trial may lead to savings for healthcare payers based on the trial results; while patient benefits remain at least the same.
Occasionally, a trial may deliver immediate savings for health care payers, just by running the trial, in addition to possible patient benefit. Examples are trials that investigate a shorter duration of an expensive drug/treatment or trials that compare an expensive to a cheaper treatment option, both of which are currently reimbursed.
Based on the trial results, there is a possibility to increase patient benefit/quality of life at a reasonable cost.

To be able to evaluate this criterion, the applicant must provide a good estimate of the costs for the health-care payer (whether RIZIV-INAMI, patients, etc…) of both interventions and relevant alternatives (immediate short term costs). If possible, an indication or description of the potential impact on cost-effectiveness and costs in the longer term is given (e.g. expensive events avoided).An overview of the general selection criteria and specific criteria for the 2017 call can be found below.

WHO CAN SUBMIT A STUDY PROPOSAL (OUTLINE) TO THE 2017 INVESTIGATOR-LED CALL?

KCE Trials considers the involvement of a clinical trial unit (CTU) essential for trial design and conduct. Therefore, investigators should have the written support of a CTU when submitting an outline.The sponsor team (Chief investigator and CTU) should have the necessary skills, procedures and experience in conducting non-commercial multicentre trials and have the ability to comply with all sponsor related obligations under the applicable laws, including the law of May 7, 2004. If the sponsor is not located in Belgium, they must demonstrate that they benefit from advantages that are similar to the advantages that apply to non-commercial multicentre trials in Belgium (the law of May 7, 2004).

HOW TO SUBMIT A STUDY PROPOSAL (OUTLINE)?

The call will be open to submissions from 18th January, 2017 until 13h on 21st March, 2017
As a first step, candidates are asked to submit a research outline. The outline should contain the above mentioned possible efficiency gains for the health-care payer. Shortlisted candidates will be invited to submit a full research proposal at a later stage.
All submissions must be done using the dedicated outline form which can be found here. A guidance document on how to complete the outline is available on the KCE website. The completed outline form and applicable attachments should be sent to Trials”at”kce.fgov.be as a pdf document by 13h on 21st March 2017. No paper submissions will be accepted.

To be deemed valid and to enter the selection process, a submission should:

Be received by email before the deadline of 13h on 21st March 2017
Be submitted using the appropriate form and be readable
Include details of chief investigator and candidate sponsor
Include a signed letter of support by a candidate sponsor who qualifies 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, they must demonstrate that they benefit from advantages that are similar to the advantages that apply to non-commercial multicentre trials in Belgium (the law of May 7, 2004).
Include a clearly defined research question in the PICO format (Patients, Intervention, Comparator, Outcome)

Read here the Top ten tips and tricks for a successful research outline

WHAT HAPPENS NEXT?

All research outlines received will be assessed for whether or not they are within the scope of the 2017 call. To be considered in scope for the KCE Trials 2017 programme, a research proposal should answer a comparative effectiveness question comparing interventions that already have a proof of concept and are already (even occasionally) used in Belgium. Development trials and implementation studies will be excluded. The primary aim of the trial should be non-commercial.
Research outlines that are within scope will be scored by a panel of clinical experts and health economists and prioritised by the KCE Trials Prioritisation Group.
Candidates will be informed about the results of the selection procedure in June 2017 at the latest (no individual feedback will be provided).
Shortlisted research outlines that are considered highest priority will be evaluated for their methodological quality and scientific value by the Trials Board (TB). The first Trials Board meeting for the 2017 call is planned early in July.
For outlines that are shortlisted and invited to submit a full research proposal (FRP) during the TB meeting in July, the sponsor team will have at least 6 weeks to develop and submit their FRP. FRP Form and guidance notes for the 2017 call will be provided in due course.

For more information, please contact Trials”at”kce.fgov.be.

Please note that KCE shall remain entitled at all times to postpone, suspend and/or withdraw any research call (even during the negotiation of the research agreement) upon its own discretion and that KCE shall under no circumstances be obliged to select any pending Full Research Proposal (FRP) or enter into a research agreement after FRP selection. Candidate sponsors can withdraw their submission at any time before signature of the research agreement.

Questions and any possible complaints regarding decisions of the TB, PG and KCE Board can be sent to trials”at”kce.fgov.be. Decision are final however and there is no organised administrative appeal procedure for candidate sponsors to appeal the decisions.

SELECTION CRITERIA KCE TRIALS 2017

Specific criteria investigator-led call 2017

Expected return on investment (ROI)

Highest score: substantial cost savings are expected. Either substantial savings per patient for small populations as well as savings for large populations that are substantial because of the size of the population fall within this category. Interventions with an equivalent effectiveness that result in relevant cost savings compared with existing alternatives also fall within this category.High score: Increased patient benefit comes at acceptable extra expense for society.Low score: It is very questionable whether the increased patient benefit comes at an acceptable extra expense for society. Research outlines that contain insufficient information to judge the expected ROI will receive a low score.

General criteria

Need for Evidence	The importance or burden of the health or care problem to those who would use the evidence generated by the proposed study. In particular, whether the trial would likely lead to improved health and care in Belgium and contribute to change in practice. What the proposed study would add to the existing body of knowledge based on a well-documented search for completed and ongoing research.
Value for Money	The proposed costs of the research are reasonable and commensurate with the work involved. The costs of the trial are reasonable in relation to the likely benefit of the research to decision-makers, patients and the public. In particular, in addition to the health benefits, the results of the research could lead to net saving for the Belgian healthcare system budget or the introduction of more cost-effective interventions (return on investment). The trial results can have an immediate and important impact on the efficiency (decrease of the costs and/or improvement of the results) of the Belgian healthcare system, preferably without the need for an additional implementation project. (see specific criteria 2017)
Sponsor	The sponsor’s team has the necessary skills, procedures and experience in conducting non-commercial multicentre trials and has the ability to comply with all sponsor related obligations under the applicable laws, including the law of May 7, 2004. The candidate sponsor allows KCE to verify these requirements during a visit. If the sponsor is not located in Belgium, said sponsor must demonstrate that it benefits from advantages that are similar to the advantages that apply to non-commercial multicentre trials in Belgium (the law of May 7, 2004). The investigators in all study sites demonstrate an expertise in the disease and patient population that will be studied.
Design	The study design would answer the research question proposed. The trial is a comparative effectiveness trial of interventions in use in Belgium, without limitation in terms of therapeutic domain or type of intervention or comparator. Trials evaluating new interventions in development would be excluded. The trial interventions should reflect Belgian current clinical practice as close as possible. A randomised, multicentre design is highly preferred. The use of centralised randomisation and e-CRFs are recommended. A pragmatic design is to be selected if this would be most informative. Only a limited set of variables, needed for the pre-planned analyses, are to be collected. All variables collected need to be well justified
Patients	The number of participating sites is sufficiently high and the investigators have access to a sufficient number of eligible patients such that the planned recruitment period is kept as short as possible while fully respecting the scientific rigour of the trial. In addition, measures are in place to maximally reduce the risk of a delay in recruitment including the absence of competing trials that may hamper patient recruitment. The investigators allow KCE to verify these requirements during a study site visit.
Timelines	The risk of recruitment delay is considered low. The relevance of the trial results at the time of publication should be justified.
Implementation	KCE strongly encourages patient involvement in research. The involvement of patients and public in the development of the project and their continued involvement through the lifecycle of the research project.
Patient and public involvement	KCE strongly encourages patient involvement in research. The involvement of patients and public in the development of the project and their continued involvement through the lifecycle of the research project.
Terms and conditions of the research agreement	The terms and conditions of the proposed collaboration between sponsor and KCE should be acceptable (see collaboration agreement version 1.2).