2024/01 - Latest news from KCE Trials

Here is the latest news from our programme:

At the end of September, we received 20 research proposals under the investigator-led 2023 call. For the first time, we shortened the review period so that all applicants were informed of the status of their proposal before the winter break. Seven proposals remain in the selection process. More information on the selected projects will be communicated before the summer.
We have published a new Policy on Research Transparency and a monitoring report on our practices. See our last newsletter for full details.
We continue our commitment to building the capacity of Belgian clinical trials centres (CTCs) and Belgian research teams. In 2024, four visits are planned to follow-up on previous gap assessment visits carried-out in 2016-2017. We also plan individual study audits to verify compliance with the legal requirements in the KCE contract.
Individual benchmarking feedback has been sent to hospitals participating in several KCE funded hospital-based studies. Congratulations to UZ Gent for including the most participants with an impressive 1,233 participants. UZ Brussels was in second place with 834 participants. A big thank you to all recruiting centres, the participants and their families.
In autumn 2023, we held some interesting training sessions for CTCs and funded teams on how to write a clinical trial report and how to navigate in the new Medical Devices Regulation. The 2024 training program has been already communicated to CTCs.
We have joined the Remedi4ALL Funders Network, a European network of funders of drug repurposing studies. Drug repurposing consists of finding new therapeutic uses for existing medicines. Under certain conditions (i.e. the drug is off-patent), these projects are eligible for funding through our calls for proposals.
KCE Trials Team

KCE Trials team

Funding Opportunities

CALL 2024 In preparation

There is currently no call open.
More info will be communicated soon on our 2024 investigator-led call

Progress in funded studies

We are happy to announce the following important milestones have been reached in the trials below:

BE-QUILT New study Contract signed		The contract has been recently signed for the study BE-QUILT: a comparison of ‘quilting sutures’ with ‘conventional’ sutures and drain placement’ after mastectomy: a multicentre, pragmatic randomised controlled trial. The chief investigator is Pr Dr Smeets (UZ Leuven). The study will recruit 296 participants in 14 sites. >> read more
RECOVER@HOME Pilot New study Contract signed		The contract has been recently signed for the study RECOVER@HOME Pilot: Recovery from disability after geriatric-home rehabilitation versus standard of care: a pilot trial in older patients with disability at hospital discharge. The chief investigator is Prof. Theo Van Achterberg (KU Leuven). The pilot study will recruit 24 participants in 2 sites. >> read more
REPAIR Open to recruitment		The REPAIR study will evaluate the effectiveness of Attachment Based Family Therapy (ABFT) compared to treatment as usual in suicidal young adults. The Belgian national coordinator is Prof. Bosmans from KU Leuven. 138 participants will be randomized across 13 sites in Belgium and in the Netherlands. The study has been funded under the BeNeFIT-2 call. >>read more
UNLOCK Recruitment completed		65 patients have been recruited in UZ Brusselt in the UNLOCK pilot study (Nutrition and locomotoric rehabilitation in Long Covid). The chief investigator is Dr De Waele (UZ Brussel). Results are expected in 2024. >> read more
ARON Recruitment completed		All 7000 patients have been recruited in the ARON trial, assessing the impact of clinical guidance & point-of-care CRP in children. The study is led by Prof Jan Verbakel and his team at ACHG, KU Leuven with participation from the academic centres of general practice of U Gent, U Antwerp, U Liege, UCL Louvain and VUB. Results are expected in 2024. >> read more
BLENDED Recruitment completed		446 patients have been recruited in 9 mental health care centres in the BLENDED study, Blended Care Psychodynamic Therapy or Cognitive Behavioral Therapy versus Face-to-Face Psychotherapy for Depression: A pragmatic multicentre randomized controlled non-inferiority trial. The chief investigator is Dr Luyten (KU Leuven). Patients are still in follow-up, results are expected for the end of 2024. >> read more
AGNOHSTIC Recruitment completed		419 patients have been recruited in 9 hospitals in the AGNOHSTIC study (Hyalobarrier® gel endo versus none following operative hysteroscopy for improving reproductive outcome in women with intrauterine pathology wishing to become pregnant). The chief investigator is Dr Weyers (UZ Gent). Patients are still in follow-up, results are expected for the end of 2024. >> read more
BENEFICIAL Study completed		332 patients have been recruited in 8 hospitals and the last patient has completed the study. The study investigates the impact of bedside model-informed precision dosing of vancomycin in critically ill children. The Chief Investigator is Dr Pieter De Cock (UZ Gent). Results are expected in 2024. >> read more

The KCE Trials complete portfolio comprises 54 studies. more info>>

Impact

The latest scientific publications including results are presented below, and links to all publications can be found on the last tab of our dynamic dashboards.

Results Dawn antiviral	November 2023	BJGP Open	The DAWN antivirals trial: process evaluation of a COVID-19 trial in general practice
Results CONFIDENT	October 2023	NEJM	Convalescent Plasma for Covid-19–Induced ARDS in Mechanically Ventilated Patients
Results Big Bird Qualitative study	April 2023	JMIR Form Res	Implementing Blended Care to Discontinue Benzodiazepine Receptor Agonist Use for Insomnia: Process Evaluation of a Pragmatic Cluster Randomized Controlled Trial
Results PELICAN	April 2023	Pain Research and Management	Considerations on the Obstacles That Lead to Slow Recruitment in a Pain Management Clinical Trial: Experiences from the Belgian PELICAN (PrEgabalin Lidocaine Capsaicin Neuropathic Pain) Pragmatic Study
Results SafeBoosc	April 2023	NEJM	Cerebral Oximetry Monitoring in Extremely Preterm Infants