KCE Trials selects and funds the clinical trials, but does not conduct them itself. The study sponsor (person or organization initiating and conducting the trial, referred to as sponsor) is the hospital or research team that proposed the study and developed the study protocol. The term "sponsor" therefore has no commercial connotation here.
According to the Belgian legislation, usually university hospitals or other research organizations can be non-commercial sponsors. They can organize and conduct clinical trials.
The sponsor has the following tasks:
- development of the study protocols;
- data management, statistics, design and implementation of electronic forms and the database;
- management of requests to appropriate regulatory authorities and medical ethics committees;
- selection, training and management of research teams and clinical sites;
- quality management and monitoring of the trial;
- reporting of safety incidents (safety findings);
- management of medication / interventions and samples;
- management of the central laboratory and logistics;
- data analysis and reporting (Clinical Study Report);
Two types of calls for study proposals (workstreams)
Investigator-led workstream: it is a "bottom-up approach": the researchers themselves submit research topics, across a wide variety of domains, in response to calls from KCE Trials.
Commissioned workstream: This approach is "top-down". The topics are selected by a panel of experts, who discuss how they could improve patient care and the effectiveness of the health system. Then a call is made to find a sponsor for the study.
Most proposals are submitted by Belgian teams. In addition, KCE Trials participates or finances the participation of Belgian teams in international clinical trials that could be beneficial to the Belgian health system.