KCE Trials Programme

KCE Trials Belgian Health Care Knowledge Centre is an independent research centre that provides scientific advice on topics related to health care. KCE Trials, a department of KCE founded in 2016, has been created on the example of the HTA comparative effectiveness from NIHR in UK. KCE Trials selects and funds non-commercial large multi-centre pragmatic randomised clinical trials in Belgium, mainly to compare existing interventions to a standard of care.

Soon after the creation of KCE Trials, the need for a Clinical Trials Management System (CTMS) was recognised, a public tender was organised to select the best candidate, and EDGE was selected in 2018. It took 6 months of implementation to tweak the system to suit the Belgian healthcare landscape, and EDGE Live was eventually operational on September 1, 2018. Nine large academic hospitals were the first subscribers in Belgium.

At the date of June 2020, 17 hospitals will have a subscription to the EDGE system and can use it for KCE Trials studies or for other studies. These hospitals have one or two lead admins to manage EDGE. Other hospitals without a subscription can use the system only to record their patients in KCE Trials funded studies without any other functionalities of the system. This “sponsorship” model has been developed specifically for the needs of KCE Trials. In this model, creation of logins is done directly by EDGE knowledge UK. Currently, there are 37 organisations using that model.

The coordination role of KCE Trials for the use of EDGE in Belgium is a bit different than the “typical” users in hospitals, as they are a funder of clinical trials. This is the role of KCE Trials in coordinating EDGE for Belgium:

• Organise regular lead admin meetings and ensure sharing good practice between the group

• Organise training for new lead admin (training is given by EDGE knowledge support UK) and ensure training needs of lead admins are met

• Supervise the structure of organisations/sites in EDGE to make sure it is up to date with the latest changes in the Belgian hospital landscape

• Provide basic support for lead admin (or refer the questions to EDGE UK knowledge)

• Create support material for users (for studies for the KCE Trials Programme): dictionary of data and several manuals

• Additionally, in the role of the funder of multi-centric studies, KCE trials

• Ensures that all funded studies use EDGE to monitor progress in recruitment

• Updates regularly publicly dynamic dashboards using Power BI to allow to follow (almost) in real time recruitment in all KCE funded trials (global and at a hospital level).

Antwerp University Hospital (UZA)

When UZA was looking for a solution to centralise all the clinical studies within the hospital, EDGE was introduced to us. EDGE would give us a global overview of all the clinical studies done in UZA and would also streamline the different procedures during the application process in a more uniform and controlled way. Before we implemented EDGE in the whole hospital (as the first Belgian hospital), our Clinical Trial Center (CTC) started a pilot project with the Oncology department (December 2018 – April 2019). This department conducts so many studies that it was the ideal department to partner up with.

Thanks to the colleagues of Oncology, we learned how to use EDGE in an efficient and smooth way. At the beginning, the different levels were a little bit confusing, and created a lot of additional clicks. They missed an overview in which they could summarise the main points of the study. Different features were created to fulfil their needs. For example, an attribute for the sponsors was created. Since we have to add extra sponsors to this list on a weekly basis, we chose to use an attribute instead of contacting the EDGE team all the time. Furthermore, the CTC created a folder template thanks to the input of the Oncology department. During the pilot project, we also contacted other departments, like the legal department, the Ethics Committee and the Biobank to develop different workflows. In addition, application forms were written for our researchers so that they could apply for a user account and for creating new studies in EDGE.

After the hospital-wide roll-out of EDGE in May 2019, many departments immediately started to work with EDGE. Since then and until now, we learned a lot from them. We constantly fine-tune our reports, attributes and workflows, create more of them and listen to the feedback.

EDGE offers many advantages: we can capture all the data and documents in one place (e.g. we need fewer copies of a contract, since it can be consulted in EDGE = less paperwork, budget negotiations can also be kept in EDGE), follow up the GCP certificates of our colleagues, create nice reports of the studies (status, sponsors, commercial / academic…), check whether the procedures during the application process are running as they should, and there is a nice collaboration with the colleagues from the EDGE team. They are very approachable, and now we are exploring the financial opportunities in EDGE together. And thanks to the workflows, there is a smooth cooperation with different departments and we do not need to call each other all the time because you can consult the updates in the workflows.

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