A well-organised Clinical Trial Centre (CTC) offering support to investigators with the planning, conduct and reporting of the trial is crucial for a successful trial. Clinical trial experience and specialist knowledge should be available at the core of the organisation to support study performance. Conducting large-scale multicentre randomised clinical trials requires expertise at several levels beyond the scientific input. In this context, KCE Trials started in 2016 performing capacity and capability assessments at the CTCs of Belgian hospitals who had the ambition to be the sponsor of a KCE Trials funded study (see more details on the initial evaluation here). In total 13 of these visits have been conducted. The outcome of this evaluation was used by the CTCs to strengthen their competencies by centralising the already available expertise in the hospital or by expanding the services to be offered to investigators.
Correctly funding all the tasks involved in a high-quality trial is key to allow the non-commercial sponsors to allocate the necessary resources while reinforcing their know-how.
In addition, the KCE Trials team has developed and regularly updates useful tools and templates on its website (see dedicated call pages here) .
Tools and templates
• A dedicated budget tool has been published in open access in the journal Trials. This tool allows sponsors to estimate the budget for pragmatic randomised multicentre clinical trials. The tool has been finetuned since initially published based on experience and feedback received from sponsors. The tool is adapted to reflect the current financial context at every call that opens. Thanks to this tool, all clinical studies in the KCE Trials programme are funded in the same way.
• Two protocol templates have been specifically designed to help sponsors of non-commercial studies (one for clinical trials involving drugs or medical devices and another for clinical trials involving other interventions) which they may use when they submit a draft protocol with their full research proposal.
• Templates for research agreements (between the KCE and the Sponsor(s) or Belgian Coordinating Centre (BCC)) and site agreements (between the Sponsor(s) or BCC and the sites) have been adapted to the requirements of KCE Trials, in particular, the non-commercial aim and the specific data sharing and intellectual property policies.
Support for the conduct of clinical trials is also provided in the form of specific training courses, study audits, feedback and follow up:
• A follow-up of the first capacity assessment has been done in the CTCs that are actively managing KCE Trials.
• Audits of studies are done by an independent QA consultant on a selected number of studies as part of a continuous quality improvement cycle. It is part of our due diligence as a funder and helps the sponsor teams at the same time to increase the quality of the work they deliver.
• Training courses are regularly organised for study teams that are involved in KCE Trials funded studies. The training programme is established every year based on training needs identified by the study teams themselves or by KCE Trials (for instance clinical operations or GCP domains such as Risk management, Budget management, Clinical Study Report writing, Safety reporting in pragmatic trials, Computer System Validation etc).
Other support:
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