18 months of the EU-CTR – What we knew then and what we know now

As anyone with an interest will know, after much fanfare and many postponements, the EU Clinical Trial Regulation officially came into force on the 31^st of January, 2022.

Sitting here just over 18 months later, in August 2023, we realize we have learned a lot – about what the EU-CTR means for our clients in real terms, the impact it has had on the translation portion of their work, and what we can do to help them adjust gracefully.

What we knew then

At the beginning of 2022, we had all conscientiously done our homework. We knew the new regulation was being introduced to harmonize the approach to clinical trials across the EEA. The EU-CTR would mean an end to duplication of trials across member states, no more repetition of unsuccessful trials; all in all, a more efficient, streamlined process. All applications would be centralized through the new Clinical Trials Information System, more information would be made available to the patients themselves, and by 2025, the old Clinical Trial Directive would be a distant memory.

It would be a significant undertaking for all involved, especially sponsors with large ongoing trials who, in addition to the real-time changes everyone else was making, would have a significant backlog of trials to transition too. Timelines for everything, including translation, would likely be shorter. Staggered, country-specific submissions would no longer be possible. New lay summaries would need to be created and translated. But we knew it was for the long-term good of the sector, the process and – most importantly – the patients. So we researched, we prepared, and we ventured forth into a new era of clinical trial submission…

What we know now

Until the 31^st of January 2023, sponsors could choose to submit via the new CTIS or the old EudraCT system. As of February 2023, however, all new applications have had to be submitted via the CTIS only. Any trials which will have one or more sites still active by February 2025 will need to be actively transitioned from EudraCT/CTD before that time. And so, right now, we find ourselves in the very middle of the 3-year transition period, with 18 months to go until any trials not transitioned are officially terminated. So, what have we learned? Are we better placed now to get the job done than we were 18 months ago? And what advice can we impart to our clients and other parties working under the EU-CTR?

Our first piece of advice: be prepared for the fact that transitioning your existing trials may take some time. Substantial modifications may need to be made and approved across languages and member states to bring an existing trial in line with the requirements of the EU-CTR before it can transition, and this transition cannot take place while any modifications or assessments are active. With this in mind, final transition requests should be made by Q3 of 2024 at the latest to avoid missing the January 2025 deadline. It appears that the Clinical Trials Information System, which so delayed introduction of the EU-CTR in the first place, continues to slow its successful adoption, with reported issues delaying everything from submission to recruitment. However, it’s important to note that all issues are being reported and worked on in real time, so the system is constantly improving.

Secondly, know that data stored on the CTIS is publicly available. This is necessitating redaction and deferral requests to protect personal and commercial information. Some clients have used this as an opportunity to re-evaluate how to make original content templates more redaction- (and translation-) friendly through e.g. consistent terminology and formatting across languages. (Making no small difference to efficiency when working in up to 24 languages.)

Another learning to note: the file-naming conventions required by the CTIS across languages have caused some headaches for our clients. We have been able to advise based on experience, and using the official guidance available.

Last but by no means least, we continue to strongly advise our clients to stay on top of any notifications coming through the CTIS and to err on the side of caution when it comes to official timelines. It seems the intended harmonization has not been achieved just yet, with some member states requesting information additional to that specified under the CTR, and some requesting timelines shorter than the already-tight 12-day turnaround.

All in all, the last 18 months have been a relatively steep learning curve for all parties, from member states to sponsors to translation providers. Some of the changes have had immediate benefits for the process, such as changes to terminology and format, while others will show longer-term value in increased consistency across member states and streamlining of the overall system. The greatest benefit of this period of learning is that we are now very well-positioned to make the most of the 18 months that remain of the transition window. So, if you’re struggling to make the move to EU-CTR, please get in touch with the Conversis team as soon as possible. We can advise on the multilingual aspects of the process and help ensure a smooth changeover for existing trials and new submissions.