What will the upcoming Clinical Trial Regulation mean for the conduct of trials in the EU?
The long-awaited European Union (EU) Clinical Trial Regulation (Regulation (EU) No 536/2014) (CTR) will come into effect in early 2022. The CTR is intended to improve the submission and review processes for clinical trials via a centralized portal. In recent weeks, the European Medicines Agency (EMA) has confirmed that the clinical trial EU Portal and Database, the key component of the Clinical Trial Information System (CTIS), is complete and proposed a go-live date of the 31 January 2022. In this article Cromos Pharma looks forward to the full implementation of the CTR and explores how it will affect the conduct of clinical trials in the EU.
What’s new about the EU CTR?
The implementation of the CTR will bring about significant changes to the way clinical trials are conducted in the EU. It will replace the European Clinical Trials Directive (2001/20/EC) and is intended to harmonize the registration, assessment and supervision of clinical trials across all member states via the CTIS. The CTIS, set up and maintained by the EMA, will host the EU Portal and Database for all EU clinical trials. Under the current Clinical Trials Directive, rules about the conduct and assessment of clinical trials vary from member state to member state.
The CTR aims to bring about a cohesive and favorable environment across the entire EU for the conduct of clinical trials. It will promote the highest standards of patient safety while creating greater transparency of trial information. It requires consistent rules for conducting clinical trials and that information about authorization, conduct and the results of trials will be made publicly available. It aims to increase efficiency of clinical trials and will harmonize the rules for conduct across the EU.
- Boost research and innovation in the EU
- Increase efficiency, particularly for multi-country trials within the EU, by reducing duplication
- Improved collaboration and information sharing
- Greater transparency in how clinical trials are conducted
- Promotes the highest standards of safety for patient participants
- Boost patient recruitment by allowing sponsors to easily expand trials across member states
Single point of entry
The CTIS will be the single point of entry for the submission of all information about clinical trials in the EU. The clinical trial application form will contain all necessary regulatory and ethics approvals as well as updates on clinical trials. The EMA will make all information publicly available in line with pre-agreed transparency rules.
According to the EMA:
“The system will support the day-to-day business processes of member states and sponsors throughout the life-cycle of a clinical trial in a user-friendly way. It will provide regulatory oversight of clinical trials and tools for supervision and monitoring, and will contain collaboration tools, workflow and document management capabilities, accessible via individual workspaces”.
Cromos Pharma and the EU CTR
It is likely that adaption to the CTR will be a learning curve for all involved in clinical research but once successfully in operation will deliver many advantages to sponsors and assessors.
Cromos Pharma’s team can assist in smoothing your transition to the EU CTR by advising on protocol language and necessary new processes.