SMEs suffer from CTIS

Born with the aim of harmonising the application, evaluation, and supervision process of clinical trials conducted in EU countries, there is much room for improvement for the Clinical Trial Information System CTIS, particularly with regard to SMEs and translational researchers.


The Clinical Trial Information System (CTIS) was born with the aim of harmonising the application, evaluation, and supervision process of clinical trials in the EU, with an emphasis on their regulatory management. This is a European regulation with a long drafting process that begun in 2014, and was finally enacted in 2023, with the mission of enhancing Europe‘’s competitiveness in the field of clinical trials. Previously, each country had its own evaluation systems, which, from the promoters’ point of view, resulted in a burden of repetitive dossier evaluations for every member state, a process made all the more complex by the differences in applicable protocols from country to country. This was cumbersome that this new evaluation process intends to harmonise.

The CTIS tool is very ambitious and has been very complex to develop. Currently, what we observe is that this tool is not functioning at full capacity. Yes, it is a functional tool that is meeting the needs of the European Commission in terms of a policy decision: to have a deadline for it to be fully operational. Therefore, priority has been given to ensuring that the tool is user friendly, rather than fully functional with all the features it could offer. It does the job today, but from the sponsors’ point of view, there is much room for improvement before it becomes an efficient tool. Nonetheless, we believe that the European Medicines Agency (EMA) is responding to the needs identified during the deployment process.

Despite this, concerns have been raised over the impact of this process on smaller companies, foundations focused on bio­medical research, or independent researchers. The current system is acting to the detriment of research areas such as rare diseases or those with a lower prevalence among the population, which are not a priority for the big players but rather areas where SMEs and academic researchers play a key role. The entire European ecosystem of dynamic SMEs and academic researchers is suffering due to its lack of resources to comply with CTIS effectively.

Although the EMA has deployed a comprehensive training program, additional resources are needed to understand and comply with it. In this respect, we believe that a specific approach towards these smaller innovators is needed from the national medicines agencies to convey all this information. Therefore, these small entities are facing difficulties to gain access to external resources or initiatives to help them address the challenges of implementation. We believe that with regards to the responsiveness from national agencies, there is still room for improvement. The problem lies in the fact that there has been no financial allocation from Europe to the Member States to manage this sweeping transformation.

Regarding clinical trials that are in transition from EUDract to CTIS, the International Pharmaceutical Federation and a series of CROs have created a working group that is holding fluid discussions with the EC to streamline transition periods. We are aware that the EMA has addressed these requests and there have been some positive changes we positively value. However, we believe that there is still significant room for improvement so that it could also benefit smaller entities so that – with a more flexible framework – they would be able to transition their trials before the set deadline of January 31st 2025, a date Europe has unyieldingly refused to extend.

In this context, whilst deeply concerned that clinical research done in Europe might be in peril, we believe that we cannot allow ourselves to waver in our determination to avert this negative prospect. Europe is a high interest market for the pharmaceutical industry, and the incentives to improve the CTIS are high because it is in Europe’s best interest, and the EU has the resources to do so. The EMA has been sensitive towards the needs expressed by the industry and some of the requirements have been recently amended. Now is the time to focus on the SME and academic research communities, providing national medicines agencies with the resources and the mandate to support smaller innovators in transitioning to the CTIS system. Europe’s innovation largely relies in this group of smaller innovators, we just need to provide them specific training and support programs to help them comply and flourish under the new framework.
This article was originally published in European Biotechnology Magazine Spring 2024.


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