KCE Trials selects and funds the clinical trials but does not conduct them itself. This is the role of the sponsor who, under the European and Belgian legislations, is defined as the individual, company, institution or organisation that takes responsibility for the initiation, management and arrangement of the financing of a clinical trial.
For the trials funded by our programme, the sponsor contracting with KCE Trials must necessarily be a non-profit institution or organisation (for instance a hospital, a university or a research organisation) that can function as sponsor of multicentre trials and has the ability to comply with all sponsor-related obligations.
Key sponsor responsibilities include:
- development of the protocol and study documents (Informed Consent forms, study plans etc)
- the registration of the trial in a publicly accessible database
- the data management, statistics, design and implementation of electronic case report forms and the database
- ensuring that appropriate approvals from regulatory authorities and/or medical ethics committees are in place
- 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 (if applicable)
- management of the central laboratory and logistics (if applicable)
- data analysis and reporting (Clinical Study Report)
- dissemination of the trials results
- archiving
There are three types of calls for study proposals (workstreams)
Investigator-led workstream: is a "bottom-up approach". The researchers themselves submit research topics, across a wide variety of domains, in response to calls from KCE Trials. Sometimes, calls for proposals are launched in a specific disease area or indication.
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 to perform the study.
International workstream: KCE Trials funds Belgian participation in international trials or will sometimes participate to international calls (such as for instance the BeNeFIT programme with the Netherlands) for trials that answer questions of importance for the Belgian patients and healthcare system. See more details here.
