KCE Trials Programme

KCE Trials is a funding programme for non-commercial clinical trials financed by the Belgian federal authorities. These clinical trials address issues that are usually neglected by industry despite their high societal importance, such as comparing treatment options with each other (e.g. two surgical techniques) or studying the effect of existing drugs on populations that are rarely considered in commercial studies, such as children or the elderly. KCE Trials finances practice-oriented and multicentre comparative effectiveness studies.

Since early 2020 KCE Trials is supporting efforts against the coronavirus pandemic by selecting and funding non-commercial clinical trials for treating COVID-19.

Despite the turmoil caused by the pandemic and its impact on ongoing studies, KCE Trials programme managed to almost double the number of ongoing trials it funds. In addition to the 4 “COVID-19” trials, 10 new contracts were signed with Belgian and international research teams, bringing the total number of ongoing trials to 30. In addition, 3 trials published their first results.

     

The KCE clinical trials are:

  • non-commercial
  • practice-oriented and focused on current standards of care: unlike commercial trials, these involve patients treated under real-life conditions (in hospitals, in the community and in nursing homes, etc…)
  • comparative: they compare the efficacy of treatments which have already been used but which have never been directly compared to one another
  • potentially able to lead to cost savings for health insurance
  • not limited to drugs or medical devices: they can also involve lifestyle modifications, psychotherapies, diagnostic tests, surgical interventions, etc.
  • guaranteed to generate databases that are made available for public interest research, for example to conduct detailed and independent cost-effectiveness studies.

KCE Trials is responsible for the selection and funding of clinical trials, but does not conduct them itself. Hospitals, universities or non-commercial research institution take on the sponsorship and coordination responsibilities.

More info: https://kce.fgov.be/en/kce-trials

 

Total budget of the COVID-19 studies

€ million

randomised patients

participating Belgian hospitals

Four COVID-19 trials


A fast-track rolling call was launched in spring 2020 to encourage researchers to propose solutions to the many problems posed by COVID-19. This rolling call resulted in three clinical trials being set up in Belgium and funding for Belgian participation in an international study (DisCoVeRy). The call was initially planned to end at the end of 2020, but the deadline was extended to April 2021 and the scope was extended to include vaccine trials.

  • COV-AID : A prospective, randomized interventional study to assess the safety and efficacy of interleukin-6 and interleukin-1 pathway blockade in COVID-19 patients with acute hypoxic respiratory failure and systemic cytokine release syndrome. Recruitment for this study has been completed and 342 patients were enrolled in 16 Belgian hospitals.
  • DAWN-Plasma: Donated antibodies against nCoV in hospitalised patients. The recruitment of this study has been completed, enrolling 489 patients in 21 Belgian hospitals. The protocol has been published.
  • CONFIDENT: A multicentre randomized trial to assess the efficacy of CONvalescent plasma therapy in patients with Invasive COVID-19 and acute respiratory failure treated with mechanical ventilation. The protocol has been published.
  • DisCoVeRy: Multi-centre, adaptive, randomized trial of the safety and efficacy of treatments of COVID-19 in hospitalized adults.

First full study results published

In November 2020, the results of our first three completed clinical trials were published in international journals. The results of a pilot study are also available.

report-icon

ELMO: The effect of evidence-based decision support for ordering laboratory tests in family practice: a cluster randomised trial. Result: the use of an electronic decision support tool integrated into the patient’s medical record makes it possible to reduce the volume of laboratory tests prescribed without increasing the risk of diagnostic error.

KCE-16012: A medical device trial to evaluate the use of a silicone adhesive multilayer foam dressing as prevention for pressure ulcer development in hospitalised patients. Result: The dressings studied reduce the incidence of pressure ulcers of category 2 or higher when used in addition to usual care. The results show a decrease for pressure ulcers at the sacrum.

VINCA: Comparison of the impact of two vincristine administration methods on vincristine-induced neuropathy in children treated for cancer. Results: The study shows that there is no significant differences between the two routes of administration. This applies to neuropathy as well as to the reported quality of life, medical costs and therapeutic effectiveness. However, differences could be seen in children who were simultaneously given medication (azoles) against fungal infections, where the risk of neuropathy was less with a one-hour infusion. The way in which children process vincristine appears to differ greatly from one individual to another. The researchers hope to be able to better predict which dose and which administration route works best for which group of children. (Copyright Mediator ZonMw)

OptiMED: Multidisciplinary medication review in nursing homes to evaluate the appropriateness of prescribing – a pilot feasibility study. Results of the pilot study: the OptiMED intervention seems to show a decrease in the volume of medicines and inappropriate use without affecting patient safety. However, some improvements to the intervention are still needed before a larger scale study can be considered.

Ongoing studies

We have set up a dynamic dashboard displaying the recruitment status of studies funded by the KCE Trials programme in Belgian hospitals and in other settings (general practice, mental health centres, etc.). This dashboard is updated every Friday, based on the data entered in EDGE Belgium by the recruitment sites.

Figures for the KCE Trials programme at the end of December 2020:

participating hospitals

participating GPs

total recruited patients

€ million mean budget  per trial

Clinical trials in analysis phase

  • DOMINO: Diet or Medication in Irritable bowel syndrome.
  • PELICAN: Localized neuropathic pain: a study to compare topical treatment versus systemic treatment

Clinical trials with completed recruitment

  • CareRA 2020 : COBRA-Slim treatment strategy with or without fast access to TNF blockade for remission induction in early rheumatoid arthritis.
  • Big Bird: The effectiveness of a blended care program for the discontinuation of benzodiazepines use for sleeping problems in primary care: a clustered randomized trial.

Clinical trials recruiting participants

  • BeNeBio (BeNeFIT*): Dose reduction of the new generation biologics (IL17 and IL23 inhibitors) in psoriasis: A pragmatic, multi-centre, randomised, controlled, non-inferiority study.
  • PRECISE (BeNeFIT*): The impact of high versus standard enteral protein provision on functional recovery following Intensive Care admission: a triple blind randomized controlled trial in mechanically ventilated, critically ill patients.
  • BeNeDuctus*: Multi-center, randomized non-inferiority trial of early treatment versus expectative management of patent ductus arteriosus in preterm infants.
  • ADVOR: A multi-center, randomized, double-blind, phase IV clinical trial on the diuretic effects of Acetazolamide (Diamox ®) in patients with Decompensated heart failure and Volume OveRload.
  • AGNOHSTIC: Impact of the use of HYALOBARRIER® GEL ENDO following operative hysteroscopy for improving reproductive outcome in women with intrauterine pathology wishing to become pregnant.
  • BLENDED: Blended Care Psychodynamic Therapy or Cognitive Behavioral Therapy versus Face-to-Face Psychotherapy for Depression: A pragmatic multicentre randomized controlled non-inferiority trial.
  • BLING III*: A phase III randomised controlled trial of continuous beta-lactam infusion compared with intermittent beta-lactam dosing in critically ill patients.
  • RenoMet: Metformin as RenoProtector in Non-Diabetic Patients with Progressive Chronic Kidney Disease (CKD stages 2, 3A and 3B): a multi-centre, practice-oriented, repurposing, double-blind, placebo-controlled, randomized clinical trial.
  • ALLTogether1*: Evaluation of various treatment protocols for trial for children and young adults with acute lymphoblastic leukaemia (ALL).
  • BENEFICIAL: A Multicentric, Randomised Controlled Clinical Trial To Study The Impact Of Bedside Model-Informed Precision Dosing Of Vancomycin In Critically Ill Children.
  • GonoScreen: Efficacy of screening sexually transmitted infections (STI) in men having sew with men (MSM).
  • SAFEBOOSC III: A pragmatic, open label, multinational randomized phase III clinical trial evaluating treatment based on near-infrared spectroscopy monitoring versus treatment as usual in premature infants.
  • IODA: Feasibility of conducting a pragmatic, randomized trial that compares Immediate versus Optional Delayed surgical repair for treatment of acute anterior cruciate ligament injury.

Clinical trials in the start-up phase

  • KIWI*: Bronchodilators for wheeze in young children presenting to primary care: a randomised, placebo-controlled, multicentre, parallel group trial.
  • DUET*: Azole-echinocandin combination therapy for invasive aspergillosis. A randomized pragmatic superiority trial.
  • RESET*: Randomized Evaluation of Surgery in Elderly with Traumatic Acute SubDural Hematoma.
  • ARON: Impact of clinical guidance & point-of-care CRP testing in children on antibiotic prescription by general practitioners.
  • HYFOIL: Impact on conception after additional tubal flushing with oil-based contrast versus no additional flushing: a randomised, multicentre, pragmatic trial in women experiencing difficulty conceiving with at least one patent tube at HyFoSy.
  • Foot Drop: A prospective, multi-center, randomized, parallel-group controlled PILOT trial to compare conservative versus surgical treatment of foot drop from peroneal nerve entrapment.
  • C-EASIE: Early administration of Vitamin C in patients with sepsis or septic shock in emergency departments: a multicentre, double blinded, randomized controlled trial.
  • SurLym: Comparison of reconstructive surgery versus no surgery, additional to decongestive lymphatic therapy (usual care), for the treatment of lymphoedema. A multicentre, pragmatic randomised controlled trial.

Some of these studies (VINCA, BeNeDuctus, BLING III, SafeBoosc, ALL Together1 and DisCoVeRy) are carried out within the framework of international multi-centre collaborations. In these cases, a Belgian hospital takes over the coordination of the research for the whole of Belgium and acts as the single point of contact for the project at the international level. Three other studies are carried out within the framework of the BeNeFIT project (see below).

BeNeFIT

KCE is co-financing certain trials with its Dutch counterpart ZonMw within the scope of a joint call called BeNeFIT (Belgium-Netherlands Funding of International Trials). Numerous issues relating to healthcare are in fact relevant for both countries; the development of joint selection processes and exchanges of best practices between researchers helps strengthen the expertise of both teams and obtain results more quickly. The BeNeFIT project currently includes five studies resulting from the first call launched in 2018.

A second call opened in 2020 yielded 41 proposals, which are currently being evaluated.