Starting from 31st January 2023, all new clinical studies with sites in one or more EU countries must be submitted under the European Union Clinical Trial Regulation (EU CTR) utilizing the Clinical Trial Information Systems (CTIS). Additionally, existing trials submitted under the Clinical Trial Directive will need to transition to CTR before adding any new countries/member states.
These evolving regulatory changes require clinical teams to establish new practices to ensure their submissions in the region move forward smoothly and without delays. EU CTR experts Sherry Merrifield, Senior Director, Enterprise Operations, Strategy and Delivery and Charlie Bergqvist, Director, Research and Development (R&D) Advisory at Syneos Health have highlighted some key considerations for teams starting – or evolving – their EU CTR and CTIS transition practices:
- Train teams to react to tight(er) timelines. The new regulation provides only 12 calendar days to complete the required authoring, translation and redaction of responses to requests for information (RFI). From our experience, this timeline crunch has had a very high impact on many teams. How can clinical teams respond to this shortened timeline? “Focus should be directed towards improving the quality of original submissions to mitigate against future responses for information queries," highlights Bergqvist. In addition, teams need to look into high quality training for current CTIS users to avoid portal uncertainties and technical issues delaying response timelines.
- Prepare for an increased amount of published clinical trial information. How teams identify and address protected personal data (PPD) and company confidential information (CCI) are an important part of the new disclosure requirements. “PPD and CCI definitions should be identified and shared with submission authors during strategic development in order to avoid delaying timelines further downstream. All document authors need proper guidance on transparency requirements,” says Merrifield.
- Review clinical research organization (CRO) oversight mechanisms. While EU CTR requirements are unlikely to result in sponsors updating their outsourcing models, the introduction of new and updated roles and responsibilities are likely to result in a review of oversight approaches and updates to outsourcing agreements and contracts. With regards to outsourcing CTIS portal-related activities, teams need to define the workflow between sponsor and CRO oversight and responsibility for trial operational activities. “We have found that successful partnerships leverage customized, multi-stakeholder approaches and are defined by sponsor readiness, the program complexity and the submission delivery strategy,” says Merrifield.
It is important to note that flexibility will be essential to adjust to the changing global regulatory landscape and CTIS variability. As the number of EU CTR submissions and resulting experience increases, teams should expect to adapt in response to these learnings.
Does your team require support to ensure compliance with regional specific regulations? Explore how the R&D Advisory team at Syneos Health can help your team navigate these and other regional regulations.
Director, R&D Advisory, Consulting
Senior Director, Senior Director, Clinical PMO
Senior Consultant, R&D Advisory, Consulting