KCE Trials is a funding programme funded by the Belgian health authorities to generate high quality evidence needed to improve and shape the Belgian public healthcare system.
To ensure that publicly funded research effectively benefits the public healthcare system and patients, KCE imposes important data sharing obligations and specific intellectual property provisions. It also strictly regulates the possibility of commercial exploitation of the results of any studies it funds.
Deviations from these core provisions (implemented in our agreement templates) are not permitted.
Data sharing & right to use the results
In return for its funding, KCE and similar agencies, have the right to access the Belgian data generated by KCE funded trials after the end of the trial and to use the results for public health purposes. For instance, after the clinical trial, KCE may conduct a health economic analysis and therefore need to link the (coded) clinical trial data of Belgian study participants with administrative data (e.g. healthcare expenditures such as number of specialist visits, stays in hospital or procedures, death records,..). To make this linkage possible, our contract templates require the collection of the national number of Belgian trial participants by participating hospitals.
In any case, KCE will only receive pseudonymised and coded data and will never be able to identify the study participant. Any data transfer will be done in full compliance with the General Data Protection Regulation.
As we fund trials using public money and in the public interest, third parties have the right to access the trial data and use the results for further research, on a non-exclusive basis and on fair and reasonable terms.
Ownership and management of Intellectual Property (IP)
The ownership of IP generated by KCE-funded studies should be vested in the institution or organisation carrying out the research in Belgium and contracting with KCE (the sponsor or the Belgian Coordinating Centre in the case of an international trial).
This institution or organisation should identify, protect and continuously manage the IP of the study in accordance with the detailed provisions of the KCE contract templates, ensuring that it can be effectively used for the benefit of the public health system and patients.
In exceptional circumstances, alternative ownership of this IP may be necessary due to pre-existing arrangements (e.g. in the case of some international trials) or to facilitate the path to patient benefit. If alternative IP ownership is proposed, the sponsor must provide strong justification for its request and prior KCE approval is required.
Commercialisation
Although KCE-funded studies are always non-commercial in aim and are not intended to develop commercial products, in exceptional circumstances there may be opportunities to commercialise certain aspects of the results. Therefore, the sponsor is required to ask KCE's prior approval for any direct or indirect commercial use of the data and results generated by the trial (including via a spin-off). KCE will evaluate such proposed commercialisation against the purpose and general public interests, and specifically the interests of the patients and healthcare payers.
