The European Union (EU) Clinical Trials Regulation (CTR) harmonizes the processes for assessment and supervision of clinical trials throughout the EU. Effective from January 2022, it means to foster innovation and research in the region.
Prior to the CTR, clinical trial sponsors had to submit clinical trial applications separately to national competent authorities and ethics committees in each country to gain regulatory approval to run a clinical trial. With the new CTR, sponsors need only submit one application for approval to run a clinical trial in several European countries, making it more efficient to carry out multinational trials. Moreover, legally being a regulation rather than a directive like its predecessor means that the new CTR is binding in all EU member states immediately without any national legislation being required, ensuring the desired consistency across the region.
A transition period applied to clinical trial submissions under the CTR but since January 2023, clinical trial applications must be submitted via the new online platform, the Clinical Trials Information System (CTIS). Additionally, from January 2025, any trials approved under the prior directive that are still ongoing must comply with the CTR and must have trial information captured in CTIS.
Three Impacts of CTR
While the new EU CTR is hailed as a positive change and enabler in the region, it will undoubtedly place stress on sponsors to file more data and submit in a different way. Here are three things that stand out as benefits from this revised, enhanced regulation:
Increased Trial Master File (TMF) Retention Period
There are new requirements and more documentation to be filed generally under the new CTR. However, the current TMF Reference Model artifacts seem adequate overall, perhaps with some extra sub-artifacts. The greatest impact on the TMF is regarding its long-term storage. Henceforth, the CTR mandates data to be available in a readable and usable state for 25 years from the end of the clinical trial, which could be a costly endeavor.
Personal and Company Data Protection
Redacted, “for publication” document versions are now to be created and uploaded to CTIS along with the full document versions. This will prevent publication of personal protected data, needed for patient privacy and safety. It will prevent the publication of confidential company information, which should help appease pharma’s competition concerns. Regardless, the effort in producing those redacted documents will be a significant new burden.
Health Literacy Empowerment
The CTR – for the first time ever – mandates lay persons’ versions of the protocol synopsis and clinical trial summary report. These lay summaries are aimed at both study participants and the public. This will go a long way to reducing complexity of clinical trial information and increasing transparency. A much-needed step toward greater patient empowerment and health literacy, though typically extra work for sponsors.
As you can see, the CTR touches and evolves various areas of clinical trials. The European medicines regulatory network publishes monthly figures on clinical trial applications and approvals to share progress on the implementation of the CTR. Data for the first quarter since the CTIS milestone is now available, and while we do not have enough data yet to hail major successes, the figures thus far show an upward trend both in applications and positive decisions.
It also shows which EU member states are more active in clinical trials, commercial/non-commercial trial splits, mono-national vs multinational trials, amongst other data. An interesting monthly read to keep abreast of progress and follow trends that are sure to surface over time.
Regulation Updates Require Agile Technology Solutions
The reality is that regulations will continue to change. Technology can enable organizations to speed up data gathering and compliance, but it must be agile enough to maintain compliance. For example, having a next-generation eTMF system is an essential step for any organization, whether sponsor or CRO. By having a solution that supports not only the clinical documentation you need but also aligns to global standards, organizations can always keep up with the latest recommendations like the EU CTR without issue.
Learn more about how LifeSphere eTMF provides the next-generation solution for your organization, keeping your TMF compliant and inspection-ready via this checklist or contact us for a demo today to learn more.