CTCs are a key element in the set-up and conduct of trials
Within the framework of the KCE Trials Programme, KCE selects and funds large, multi-centre pragmatic randomised trials but does 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 the KCE Trials Programme. Potential sponsors can submit their application to one of those calls. 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 the principles of ISO 14.155 and ICH-GCP E6 (R2) with special attention to the sponsor responsibilities in section 5 of this guideline. Based on the past experience in KCE funded trials, the involvement of a Clinical Trial Centre has been shown to be a key element to obtain robust high quality trial results. The commitment and the support of a CTC is therefore a requirement when submitting an application to a call.
Data on available capabilities and capacities at sponsor sites
Although Belgium has a long history of excellent clinical research, the conduct of large, non-commercial, multi-centre, randomised, pragmatic clinical trials was fairly new at the start of the KCE Trials Programme in 2016. At that time, data on available sponsor capabilities and capacity at universities and hospitals were lacking. This was the motivation for KCE Trials to perform a gap analysis at the different potential candidate sponsor sites in Belgium that had established experience in running randomised multicentre trials. A gap analysis was conducted during a 2-day visit performed by an independent Quality Manager and a KCE-representative as observer.
While the initial focus of the gap assessments was on the university hospitals, we also visited some large non-university hospitals with a strong research tradition.
From the start of the programme in 2016 up to 2019, 12 hospitals have been visited (all 7 academic hospitals, 5 non-university hospitals and institutions with a strong research tradition and a Clinical Trial Centre). The exercise revealed that the sponsor expertise was often scattered throughout the different departments at the hospitals visited, raising questions of global oversight, continuity, standardisation and building on expertise. However, some hospitals had already invested extensively in the development of a CTC, while others were still in the early development phase.
Since the first gap assessments were done, we have seen within our programme that in almost all hospitals visited, the hospital management have continued to invest in the development of their CTCs by expanding centralised monitoring, data management and other oversight activities.
Continuous Quality Improvement
In the post-pandemic era, KCE Trials aims to continue its commitment to capacity building. This, in combination with our due diligence as a funder drives KCE Trials to move to a second phase in quality assessment. In 2022 a new candidate sponsor was visited for a gap assessment. Follow-up visits of the previously performed gap assessments, focusing on the CAPA plans that were provided by the sponsors will be scheduled over the coming years. Individual study audits to check compliance with legal requirements and the KCE contract are planned for a subset of KCE funded studies.
We are convinced that all these actions will help the sponsor teams to increase the quality of their work and further expand their knowledge and competences resulting in publicly funded trials of high quality.
Training for CTCs and study teams
After the initial gap assessments, common areas for capacity building could be identified. Therefore, KCE Trials has set up a training programme to support the development of the CTCs in this respect. The training programme is established every year based on training needs identified by the study teams themselves or by KCE Trials. It covers topics such as project management, health economics, budgeting and financial management, patient and public involvement in trial design and conduct, pragmatic trials, safety reporting, risk management etc.
Due to capacity reasons, we have to restrict the training programme to CTCs and teams that have submitted to our call or that were visited for a gap assessment.
By bringing together the CTCs 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.
Researchers not linked to a CTC
For researchers who don’t have a connection to a CTC, please contact the KCE Trials Team and we will put you in contact with a CTC who you could potentially collaborate with.