Certain terms have a special meaning or significance in the context of projects funded by KCE Trials, where they are understood as follows:
| Belgian Coordinating Centre (BCC) | Centre (sometimes referred to as ‘Local sponsor’) responsible for contracting with the KCE and coordinating Belgian participation in an international study with the lead centre (sponsor) situated in another country. Some tasks this centre may perform could include managing the submission of the study to the applicable bodies and translating and adapting documentation for Belgium. |
| Chief Investigator (CI) | The person (authorised health professional) who works for the Trial sponsor* and takes overall responsibility for the design, conduct and reporting of a study if it is at one site; or if the study involves researchers at more than one site, the person who takes primary responsibility for the design conduct and reporting of the study whether or not that person is an Investigator at any particular site. |
| Clinical Trial | Strictly understood clinical trials refer to interventional studies with investigational medicinal products (IMPs). In the context of KCE Trials, this concept covers more broadly interventional clinical studies. |
| Clinical Trial Centres | Clinical Trial Centres (CTCs) are specialised facilities within hospitals or institutions that support the Chief Investigator in the conduct of clinical trials. These centres are crucial for the setup and execution of trials, ensuring high-quality results through centralised monitoring, data management, and adherence to regulatory standards. |
| Comparative effectiveness | 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 two treatments work better in a real-life situation. |
| Health Technology Assessment (HTA) | Health Technology Assessment research produces independent research information about the effectiveness, costs and broader impact of healthcare treatments and tests for those who plan, provide or receive care. |
| Implementation research | Implementation research is the scientific study of methods to promote the uptake of research findings. |
| Principal investigator (PI) | A person responsible for the conduct of the clinical trial at a specific study site. |
| Randomised clinical trial (RCT) | An RCT is a type of scientific experiment where participants are randomly assigned to different groups to compare various treatments or interventions. This random allocation helps ensure that the groups are similar, allowing for a fair comparison of the effects of the treatments. RCTs are considered the gold standard in clinical research for evaluating the efficacy and safety of medical intervention. |
| A registry-based randomised controlled trial (R-RCT) | A R-RCT is a subtype of RCT that utilises existing patient registries to identify and enroll participants. This approach leverages the comprehensive data already collected in registries, making the trial more efficient and cost-effective. |
| Trial sponsor | A non-for-profit institution or organisation that takes responsibility for contracting with KCE and for the initiation, management and arrangement of the financing of a KCE funded clinical trial. A clinical trial may have one or several sponsors where permitted under regulatory requirements. |
