What is KCE Trials?
Many questions in healthcare are currently not or not sufficiently studied in clinical trials, despite their high societal importance. The KCE concluded in the summer of 2015 that public funding of such trials would be beneficial (Report 246-2015) under certain conditions. These trials not only contribute to better patient care but also to a more efficient use of public resources.
The Minister of Public Health Maggie De Block decided in the autumn of 2015 that KCE should launch and manage a programme of pragmatic practice-oriented clinical trials. The available budget for KCE Trials in 2016 and 2017 is 5 million €, increasing to 10 million € from 2018 onwards. More information in Dutch or in French
For an efficient international and multilingual cooperation, English was adopted as a working language. For that reason all publications, communications and activities will take place in English.
Which trials are funded?
Any type of intervention, in any domain of healthcare, can be the subject of a KCE trial, thus not only medicinal products.
An absolute condition however is that the result of the trial has an immediate impact on patient care or on the efficient use of the healthcare resources and budget. Both national and international trials are eligible for funding.
In the beginning, priority will be given to trials which can lead to an efficiency gain for the healthcare system within a rather short period. Typical examples are comparative effectiveness trials, preferably randomised, comparing existing interventions.
KCE Trials does not fund early phase or development clinical research. For this research we refer to other initiatives and institutes, such as the Fonds Wetenschappelijk Onderzoek and the Fonds de la Recherche Scientifique and Innoviris.
The sponsor conducts the trial
KCE will select and fund the trials but will not conduct them. The role of the trial sponsor (the person or organisation who takes responsibility for the initiation and management of the trial) is taken by the hospital and investigator team (or similar) who propose the trial together, who also have developed the protocol. The sponsor has to conduct the trial in accordance with the applicable regulations. The concept of sponsor does not have a commercial connotation here.
The responsibilities of the sponsor include:
- Preparation of study protocol;
- Data management, statistics, design, development of forms and databases;
- Manage requests to the competent authorities and ethics committees
- Selection, training and management of the researchers and research centres
- Quality management and monitoring of trials;
- Reporting of security incidents (safety findings);
- Management of drug(s) and samples as applicable;
- Central laboratory and logistics, as applicable
- Analysis and reporting;
Three kinds of research (workstreams)
KCE Trials funds three different research approaches:
- Commissioned workstream: a ‘top-down’ approach which focuses on funding trials that will answer clinical questions which have been identified and prioritised for their importance to the patients and the healthcare system
- Investigator-led workstream: a ‘bottom-up’ approach, which begins with open calls where clinicians can propose clinical questions in any topic area.
- International workstream: KCE Trials also funds Belgian participation in international trials for selected International trials which ask questions that are also important for the Belgian healthcare system.
In the glossary some specific terms are explained