Will the European Clinical Trial Regulation attract more clinical trials to Europe?
- Natalia Ramírez Comet
- Dec 3, 2024
- 4 min read
While Euroscepticism is growing among Europeans, we would like to discuss the European Clinical Trial Regulation (CTR), drafted by the European Commission and accepted by ordinary legislative procedure, as an example of how the creation of a shared regulation by the 27 Member States forming the European Union can benefit every European individual.
Let’s start by analyzing the type of problems EU Member States were dealing with before this unifying EU regulation was implemented.
Imagine that you own a pharmaceutical company, main sponsors of clinical trials:
How many hours do you think your employees would need to spend in order to fully understand the different legal requirements of each EU country? And to write the different clinical trial applications (CTAs) to comply with these requirements? And to communicate with the different countries through different platforms during the whole application and post approval process?
Would you conduct clinical trials in small countries knowing that you will need to multiply the administrative work to have enough participants? Or would you rather choose big countries where you could get a high number of participants with less administrative work?
You can probably start to understand why most of the clinical trials conducted in the European Union have been run in populated countries like Germany, France, Spain or Italy, although of course, it is not only depending on the size of the country but also on how the health system is organized in each country and how the salaries of those that will be involved in the clinical trial also weighs into the balance.
You might by now also understand the reason behind the creation of a Clinical Trial Directive in 2001. With big competitors like Asia and the US, in which all the different states comply with the same clinical trial requirements defined by the Food and Drug Administration (FDA), a European alignment would increase the chances of pharmaceutical companies investing in European clinical trials.
But was a directive the best choice to align clinical trials in Europe and consequently become more attractive to pharmaceutical companies?
10 years later we can firmly answer that it was not. A directive is binding and, therefore, forces Member States to comply with the addressed points. However, it is not directly applicable, and thus, allows for some flexibility while transposed into national law. This flexibility impeded the desired harmonisation of the EU clinical trial’s requirements. Moreover, although not achieving the aim, the administrative burden from the directive increased, making Europe even less attractive for clinical trials.
Does this mean that trying to unify the clinical trials’ legislations of the EU Member States was a big mistake?
Not necessarily. What we can be sure of is that the first alignment trial with the Directive was a failure. But would Europe become more attractive if the alignment would succeed?
This is what the European Union continued to believe despite the results achieved with the directive and, in 2022, the new Clinical Trial Regulation was launched.
Being a regulation, this time there was no option for flexibility, as all Member States would uniformly enforce the measures provided by the regulation. Harmonisation was planned to be achieved by the following means:
- All applications for the authorization of clinical trials would be submitted through one EU portal (CTIS), instead of each Member State having its own submission method.
- A single authorization procedure: A single application submitted through CTIS is accessible by all Member States concerned and evaluated in parallel within the same defined timelines.
- There is a single set of application documents, instead of each Member State having their own forms.
- A harmonised procedure for the assessment of applications for clinical trials: the joint assessment of part I of the CTA by all the involved countries is coordinated by one reporting member state. Part II of the CTA, though, is individually evaluated by the National Ethics Committees, but they do it in parallel through the same CTIS application.
- Streamlined safety reporting by sponsors to the concerned authorities of the different Member States through a single platform, Eudravigilance, the European database for managing and analysing information on suspected adverse reactions. This spares sponsors from submitting identical information to the different Member States, as they all will have access to this database. The annual safety reports would, nevertheless, be submitted to CTIS.
The result of these measurments to align EU has not yet been assessed, as the electronic platform CTIS was not released until 2022, and it was only in 2023 that it became mandatory to send all the CTAs through this platform. Furthemore, all clinical trials previously registered under the directive will not be forced to transition to the CTR until 2025. Thus, it will take a few years to experience the whole effect of the new CTR, but so far, the time for CTA approval has improved.
A big question left is the lack of harmonisation regarding the National Ethics committees that will evaluate part II of the CTA. Why is this evaluation not a common effort as it is with the case of part I of the CTA? Why does the requirements of documents such as the Informed Consent Form (ICF) vary so much between the different EU countries? Should not all European individuals be equally ethically protected? Clear and harmonised requirements, in the different EU Member States, would most probably help the writing of an ICF in a patient-centered manner.
A final thought to leave you with;
Could a harmonisation of the requirements from the different EU Member State countries become so aligned that it could allow for each clinical trial to only needing to be evaluated by One randomly assigned EU Member State?
