Within the framework of the KCE Trials Programme, KCE will select and fund trials but will usually not conduct them. Calls for research proposals are regularly published on the KCE website and mailed to those who are registered to receive news from us. Potential sponsors can submit their application. The role of the trial sponsor (the person or organisation who takes responsibility for the initiation and management of the trial) is taken by a hospital or institution that is qualified to be a sponsor of non-commercial clinical research according to the Law of May 7th, 2004 on experiments on the human person.
The sponsor needs to be compliant with all applicable legislation and conduct the trial in accordance with ICH-GCP E6 with special attention to the sponsor responsibilities in section 5 of this guideline. KCE Trials believes that it is important that the trial oversight is done in a centralised way. Therefore the involvement of a Clinical Trial Unit is considered a key element to obtain robust high quality trial results.
Although Belgium has a long history of excellent clinical research, the conduct of large, non-commercial, multi-centre, randomised, pragmatic clinical trials is fairly new. Data on available sponsor capabilities and capacity is lacking. Therefore KCE Trials decided to perform a gap analysis at the different potential candidate sponsor sites in Belgium that have established experience in running randomised multicentre trials. For this, a CRO was selected by public tender. Each gap analysis was conducted during a 2-day visit performed by an independent Quality Manager and a KCE-representative as observer.
In a first round, the 7 university hospitals were evaluated. During 2017, several other non-university hospitals with a strong research tradition, who expressed their interest to become a sponsor for KCE trials were visited. The scope and focus of the visits was compliance with ICH-GCP and the principles of ISO 9001, in particular the sponsor processes necessary to be able to initiate, execute, manage and oversee multi-centre, randomised, pragmatic, comparative effectiveness studies. Processes reviewed were, including but not limited to:
- Overall Management System
- Selection of sponsor staff involved in the management and oversight of study conduct and relevant training
- Document Management Processes
- Quality Processes
- Study design, performance, analysis and reporting
- Site Selection and Oversight Process
- Contracting, Sub-contracting Process and vendor management
- IMP management and accountability Process
- Central Lab management and Reporting Process
- Infrastructure and IT Processes
The anonymised summary of this GAP analysis can be found here.
The exercise revealed that currently the sponsor expertise is scattered throughout the different departments at the university hospitals, raising questions of global oversight, continuity, standardisation and building on expertise. However some hospitals have already invested extensively in the development of a CTU, while others are still in the early development phase. Yet, common areas for capacity building could be identified. Therefore, KCE Trials has set up a training programme to support the development of the CTUs in this respect. This programme contains topics such as an efficient management of a trial using web-based tools, project management, health economics, defining a trial budget, patient and public involvement in trial design and conduct, pragmatic trials, etc.
By bringing together the CTUs of the different hospitals, KCE aims to stimulate discussion across the different hospitals and to develop a cross-institutional platform to share expertise in the conduct of large, non-commercial, pragmatic, randomised, multi-centre trials in Belgium.
For researchers who don’t have a connection to a CTU, please contact the KCE Trials Team and we will put you in contact with a CTU who you could potentially collaborate with.