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KCE TRIALS - PROGRESS TO DATE

2016 Call (Commissioned workstream)

1. Call for topic proposals (December 2015-February 2016)

In December 2015, KCE launched a call for topic proposals. The application period was closed in February 2016, by which time KCE had received 165 proposals.

2. Topic selection procedure (February-May 2016)

For the topic selection, the prioritisation group based itself on the general and specific criteria. Out of the 165 topic proposals, 85 topics were considered out of scope. The remaining 80 topics were reviewed by domain expert panels and scored (from 1-5, lowest to highest)

The topic suggestions that were ranked highest (14 topic suggestions with a mean or median score of at least 3.5) were subsequently reviewed by the prioritisation group.

15 topic suggestions received a mean or median score greater than 3 but less than 3.5. These moderately high-ranked topics are retained and could be reconsidered at the next prioritisation meeting depending on the further development of the highest ranked topics. For more details, see the topic selection flowchart.

For candidate sponsors a workshop was organised in collaboration with FAMPH/FAGG/AFMPS (May 20th), see slides : 

3. Call for candidate sponsors (JUNE-AUGUST 2016)

To read more click here

4. NOW: Selection of Research proposals by Trials Board (September – JUNE 2017)

The Trials Board (TB) membership is made up from senior, experienced clinicians and methodologists (including triallists, statisticians and health economists) who are all active researchers in their field.
The board considers how well projects fulfil the following criteria when assessing proposals:

  • How well the proposal addressed the issues outlined in the commissioning brief;
  • The quality of the methodology and science presented;
  • The extent to which the group had the necessary skill mix and/or experience to complete the project;
  • The evidence of the necessary project management and infrastructure to enable successful delivery of the project;
  • That the costs of the research represented good value for money
  • The potential for efficiency savings for the health care system.

Research proposals submitted by candidate sponsors to the Trials programme undergo a 2-step selection procedure:

  • 1- The submission of an initial expression of interest (EOI) by candidate sponsors outlining the key information on the research proposal: review of EOI by KCE’s Trials Board and notification of the outcome to the candidate sponsor.
  • 2- Invite submission of research proposals shortlisted by KCE’s Trials Board:  submission of a full research proposal (FRP) by the shortlisted candidate sponsors for consideration by KCE Trials Board.

This two-step approach facilitates a proportionate and timely assessment of the eligibility, feasibility and value for money of the EOI research proposals which can progress to the second stage. Only shortlisted candidate sponsors are invited and required to develop FRP for further consideration and review by KCE Trials Board.

There were two meetings of the Trials Board in 2016 (one in September, one in November). The decisions of the last TB are listed below:

Proposal Decision Trials Board November
CB-1601 Dietary intervention IBS EOI shortlisted and candidate sponsor invited to submit a full research proposal 
CB-1602 Biologicals for
early RA
EOI shortlisted and candidate sponsor invited to submit a full research proposal 
CB-1604 Nut strat bariatric surgery EOI declined, no further submissions possible in the 2016 commissioned workstream 
CB-1605 Duration anti-PD1 melanoma Proposal further discussed at Prioritisation Group, with regards to international cooperation
CB-1606 Individualised
trt haemophilia
EOI shortlisted and candidate sponsor invited to submit a full research proposal
CB-1607 Deep brain stim vs levodopa PD FRP not recommended for funding but candidate sponsor invited to submit a revised FRP 
CB-1608 chronic resp.
Azithromycin
EOI declined, no further submissions possible in the 2016 commissioned workstream
CB-1609 nocturia EOI declined, no further submissions possible in the 2016 commissioned workstream
CB-1610 Blended trt
depression
FRP declined, no further submissions possible in the 2016 commissioned workstream
CB-1611 Lab test order sets FRP not recommended for funding but candidate sponsor invited to submit a revised FRP
CB-1612 Pressure ulcer
dressings
FRP recommended for funding with changes


2016 International workstream

KCE Trials communicates regularly and on an ongoing basis with similar funding bodies in other European countries. When common priorities are identified, options for collaboration are discussed.

Now: Funding opportunities

3 Studies funded by the Dutch funder ZonMw have been identified for possible support for coordination of Belgian participation. Proposals from the Dutch lead hospitals (Sponsors) with their Belgian collaborators are awaited.

To read more click here

ContactKCE Trials
Phone : +32 (0)2 287 33 88
Email : trials@kce.fgov.be
published on 03-05-2016