CTCs are a key element in the set-up and conduct of trials
Under the KCE Trials programme, 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 non-profit organisation or institution. The sponsor needs to be compliant with all applicable legislation and conduct the trial in accordance with the principles of the latest approved version of the ISO 14.155 and ICH-GCP guidelinesE6
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 were 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 supporting high-quality trials in Belgium. This, in combination with our due diligence as a funder has driven 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 have been performed.
In addition, an ongoing programme of individual study audits, to check compliance with legal requirements and the KCE contract, is performed for a subset of KCE funded studies.
We are convinced that all these actions, combined with the correct funding of all the tasks involved in a high-quality trial 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 courses for CTCs and study teams
After the initial and follow-up gap assessments, common areas training needs were identified by the study teams and by KCE Trials. 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 identified training needs. 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 are involved in our studies.
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.
