2016 Call (Commissioned workstream)
The 2016 commissioned workstream from the KCE Trials programme commissions clinical trials that address specific topics or themes, as identified by the panels and prioritisation group during a selection process.
| ID | Topic | Commissioning Brief | Decision Trials Board |
|---|---|---|---|
| CB-1601 | Dietary intervention for newly diagnosed irritable bowel syndrome | Commissioning brief (PDF) | Shortlisted and candidate sponsor invited to submit a revised full research proposal |
| CB-1602 | Biologicals for early untreated rheumatoid arthritis | Commissioning brief (PDF) | Shortlisted and candidate sponsor invited to submit a revised full research proposal |
| CB-1603 | Step down approach for inhaled corticosteroids in COPD | On hold | NA |
| CB-1604 | Optimal nutritional supplement strategy for patients with deficiencies after bariatric surgery | Commissioning brief (PDF) | Declined, no further submissions possible in the 2016 commissioned workstream |
| CB-1605 | Optimal duration of anti-PD1 therapy in patients with advanced melanoma | Commissioning brief (PDF) | Withdrawn |
| CB-1606 | Individualised replacement therapy for haemophilia patients | Commissioning brief (PDF) | Declined, no further submissions possible in the 2016 commissioned workstream |
| CB-1607 | Deep brain stimulation versus levodopa pump in Parkinson’s disease | Commissioning brief (PDF) | Withdrawn |
| CB-1608 |
Azithromycin in children with chronic respiratory symptoms | Commissioning brief (PDF) | Declined, no further submissions possible in the 2016 commissioned workstream |
| CB-1609 |
Treatment of nocturia | Commissioning brief (PDF) | Declined, no further submissions possible in the 2016 commissioned workstream |
| CB-1610 |
Combined online and face-to-face treatment for depression | Commissioning brief (PDF) | Declined, no further submissions possible in the 2016 commissioned workstream |
| CB-1611 |
Evidence-based laboratory test order sets in first line care | Commissioning brief (PDF) | Recommended for funding with changes |
| CB-1612 |
Prevention of pressure ulcers using multilayer foam dressings | Commissioning brief (PDF) | Recommended for funding with changes |
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
MRC/DH/MHRA Joint Project - Risk-adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products
This UK report on risk adaptive approaches to the management of clinical trials of investigational medicinal products may provide practical ideas as to how pragmatic approaches can be implemented in studies. It complements existing waivers that exist for non-commercial trials.
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.
2016 International workstream
KCE Trials does not only cover clinical trials that are commissioned by KCE. In addition, KCE Trials intends to provide financial support for the participation of Belgian centres to certain international clinical trials that complement KCE’s mission statement. In such cases, KCE’s role will mainly be to assist the (international) study sponsor with the coordination of the participation of certain Belgian centres through a Belgian coordinating centre (BCC) and to fund well-specified BCC activities that are not covered by other funding.
In this context, KCE intends to provide selected additional funding for the following studies, which already received funding from ZonMw in the Netherlands.
| ID | Topic | Info | Investigator - Sponsor |
|---|---|---|---|
| KCE-16013 | BeNeDuctus Trial - multi-centre, randomized non-inferiority trial of early treatment versus expectative management of patent ductus arteriosus in preterm infants | More info on this trial | Dr Willem Deboode (Radboud umc Amalia Children’s Hospital) willem.deboode”at” radboudumc.nl |
| KCE-16014 | T4Life Trial - Levothyroxine for euthyroid women with recurrent miscarriage and positive TPO antibodies: a randomized controlled trial | More info on this trial | Dr Mariëtte Goddijn (AMC Amsterdam) M.Goddijn”at”amc.uva.nl |
| KCE-16015 | VINCA Trial - Reducing vincristine-induced peripheral neuropathy in children with acute lymphoblastic leukemia by one-hour infusions instead of bolus injections |
Accruing in Belgium |
Dr Marleen van den Berg (VUmc Amsterdam) mh.vandenberg”at” Belgium contact: An Michiels an.michiels”at”uzleuven.be Belgian Society for Pediatric Hematology and Oncology (BSPHO) |
For each of the three studies, a BCC has been identified by the Sponsor and contract negations have started. On October 12th, 2016, the first contract for Belgian participation to a ZonMw study was signed for the study on reducing vincristine-induced peripheral neuropathy in children with acute lymphoblastic leukemia.
