New European legislation on clinical trials

“The pilot project on the new regulation for clinical trials has strengthened Belgium's reputation as an expert for clinical trials”

Anne Lenaers works for the Research and Development Division (human use) of the Directorate General PRE authorisation. She worked on the implementation of the new regulation on clinical trials in Belgium. Since 2017, she worked on the pilot project, which prepared the FAMHP, the ethics committees and the sponsors for the implementation of this new regulation.

Anne Lenaers

The new Clinical Trials Regulation (EU) 536/2014 came into force on 31 January 2022. What impact does the new legislation have on the FAMHP’s daily work?
The new regulation has radically changed the way we work. The old legislation, Directive 2001/20/EC, required a authorisation from the FAMHP and the ethics committee before an academic or commercial clinical trial could start in Belgium. These two bodies worked in parallel, without consulting each other.

Our agency deals with scientific data, while the ethics committee deals with the ethical aspects. Each body issues their own opinion. The sponsor needs two positive opinions to launch its clinical trial in Belgium. During a transition period of one year, until the beginning of 2023, the sponsors can still choose the old directive as the legal basis.

The new regulation requires us to work together, as a single opinion needs to be given for each application in Belgium. This means a consolidated opinion from both the FAMHP and the ethics committee. In addition, the ethics committees are no longer contacted directly by the sponsor. The FAMHP is the sponsor’s only point of contact. We therefore had to thoroughly reorganise the way we work, in collaboration with the ethics committees.

What are these ethics committees?
Under the new regulation for clinical trials, the ethics committees are recognised and accredited under the Law of 7 May 2017 on clinical trials with medicines for human use. To this end, they had to apply to the FAMHP for accreditation. Following this request, the FAMHP’s good clinical practice inspectors inspected each ethics committee to verify whether they meet the accreditation criteria as defined in this law and its implementing decrees. Currently, in Belgium, there are fifteen ethics committees recognised to work on the evaluation of clinical trial dossiers within the framework of the new regulation.

According to the new regulation, the ethics committee in charge of a clinical trial dossier must be independent from the hospital where the trial takes place. This is also completely different from the way the clinical trial directive works: the ethics committee responsible for the evaluation is that of the hospital where the trial takes place.

So the FAMHP now works directly with the ethics committees?
No, a new body has been created: the Clinical Trial College. This college is our point of contact with the ethics committees. It is completely independent of the FAMHP and was established within the FPS Public Health. It is made up of an administrative staff composed of dossier managers and a board made up of doctors and lawyers. This board is responsible for verifying the quality of the evaluations by the ethics committees. The objective is to further professionalise the evaluations of ethics committees.

Preparing for the implementation of the new European legislation, especially when it has such an impact on clinical trials, must have been a long process …
The legislation was published in 2014. It came into effect in January 2022. Why did it take such a long time? Because it was necessary to set up a European portal, the Clinical Trials Information System (CTIS), which will be the single entry point for sponsors to register their clinical trial dossiers in Europe. It took a long time to create this portal. It was complicated, as the legislation is complex, and there is a lot of data to integrate into one portal. But in 2017 we were able to launch a pilot project, which has prepared us for the new legislation. 

Can you explain the pilot project?
The aim of the pilot project was to test the working methods in the new European legislation as well as possible: the FAMHP as the single national point of contact for the sponsor, the new way of working with the Clinical Trial College and the ethics committees … before the implementation of this new legislation. We are not the only ones in Europe to have done this. But the Belgian project was one of the projects that best relates to the future reality in the field.

The Belgian project was undoubtedly very interesting for the sponsors.
Absolutely. Belgium was already an expert in the field of clinical trials. The pilot project has undoubtedly further strengthened this position. We organised several information sessions on the progress of the project. This gave the sponsors a clear idea of how they would proceed once the new legislation was implemented. They were able to adapt their procedures accordingly. This was the best way for them to prepare. We were a victim of our own success, at a certain moment we ran out of resources and could not always meet the deadlines set out in the pilot procedure.

Why is that?
Participation in the pilot project was voluntary. Sponsors could, of course, continue to submit their applications following the traditional procedure. We hoped that many sponsors would want to participate in the pilot project. And we were not disappointed. At one point, 50 % of dossiers were submitted through our pilot project. What we did not anticipate was the time needed to process the pilot dossiers while the European portal was not yet set up. That took us much longer than expected. We received reinforcement, but it was not enough given the number of dossiers received and the preparations for the implementation of the new legislation. At the same time, many of our employees were busy with the COVID-19 crisis. In 2021, my colleague Hans Vincke and I had to train ourselves and our colleagues to use the CTIS platform. This increased the workload enormously and made us less available to process the pilot project dossiers.

So the impact of the COVID-19 crisis was huge?
Yes, not only was there a lack of resources, we also received many requests for clinical trials related to COVID-19. To help fight the pandemic, we processed these dossiers more quickly than usual – within four working days as opposed to the normal twenty days. This also took time and energy …

What lessons have you learned from this pilot project?
We were able to see that everything that had been planned worked well. of course, we also learned on the job and improved the process as the pilot progressed. Collaboration with the Clinical Trial College and the ethics committees has been refined, and we have learned to work together. All the stakeholders have also integrated the work with strict deadlines. Finally, the pilot project allowed the sponsors to practise preparing dossiers to the new requirements.

Were the sponsors and ethics committees happy with the work done?
We have received a lot of positive feedback. Apart from the problem of deadlines, I don’t think there were many problems. Everyone found this way of working effective and rewarding for clinical trials.

What is the impact of the new legislation on the workload of your team?
Under the new legislation, the FAMHP is the sole point of contact in Belgium. We are therefore receiving a number of questions that were previously addressed to the ethics committees. We also have more responsibility. The FAMHP now receives all the dossiers, including the ethical part. And, even though we don’t evaluate this part, we have to check if everything is complete. We therefore validate much larger dossiers. It gives us more work, but the organisation is smoother and the dossiers are more robust. This is positive for everyone: the FAMHP, the sponsors and especially the patients.

This new regulation is therefore first and foremost an improvement for the public and the clinical trial participants…
Without a doubt. The goal is to further improve monitoring to ensure the safety of participants, guarantee that the trial will lead to interpretable results and ensure greater transparency of clinical trials. All citizens will be able to consult the dossiers at any time. The ultimate goal is to offer innovative medicines to the general public as quickly as possible, for example for diseases for which there is no treatment yet, without ever compromising on their quality, efficacy or safety.

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