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.
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?
KCE Trials focuses on comparative effectiveness trials which show clear value for money and have the potential for return on investment. Comparative effectiveness trials compare the benefits and harms of different treatment options that are already in use in the health care system but which have never been adequately compared directly (i.e. which of 2 treatments work better in a real-life situation).
Accepted study interventions are not limited to drugs or medical devices but also include a broad range of interventions for example psychotherapy, diet, life-style interventions, diagnostic tests, surgery or ways to deliver health care.
An absolute condition however is that the result of the trial have an immediate impact on patient care or on the efficient use of healthcare resources and budget.
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, the Fonds de la Recherche Scientifique and Innoviris. Also implementation research will not be selected.
The sponsor conducts the trial
KCE will select and fund the trials. 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 or research organisation and investigator team 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.
Generally, academic hospitals or other research organisations that can act as a non-commercial sponsor under the Belgian law will organise and conduct the trials.
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 the trial
- Reporting of security incidents (safety findings)
- Management of drug(s)/intervention(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 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 funds Belgian participation in international trials or will participate to international calls for trials that answer questions of importance for the Belgian patients and healthcare system.