In May 2021, the National Office and the Health Products Regulatory Authority (HPRA) will launch the CTR-National Collaboration Project. This jointly run project will test and appraise the national preparedness for a new piece of legislation due to be implemented at an EU-level in early 2022.
This new legislation, known as the EU Clinical Trial Regulation (CTR), will bring significant changes across Europe to how clinical trials of medicinal products are assessed and regulated.
This project lays the foundations for how both the National Office and the HPRA will work together to ensure an efficient and coordinated national transition.
As part of the project, we will work closely with a select group of volunteer industry and academic clinical trial sponsors. Cancer Trials Ireland is the first organisation to sign on to the project and we are working with other organisations to identify additional industry sponsors to get involved over the coming months.
EU legislation
The CTR will harmonise the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS). This in turn will harmonise submission and assessment processes, improve collaboration and information-sharing, increase transparency, and further improve standards of safety for research participants – collectively fostering an environment that is more favourable for conducting clinical trials across the EU.
The CTR will increase the efficiency of all trials in Europe with the greatest benefit for those conducted in multiple EU countries. It aims to foster innovation and research, while helping avoid unnecessary duplication of clinical trials or repetition of unsuccessful trials.
National Collaboration Project
Under the current structures, the HPRA and the research ethics committees (REC) system work independently of one another. This will change when the CTR is implemented, as one “single decision” per EU country will have to be provided through the CTIS.
Through the Collaboration Project, we will work through the CTR timelines and processes for review of a select number of clinical trials ahead of the application of the CTR in early 2022. The Collaboration Project provides an opportunity for learning for all stakeholders. It will facilitate the ongoing development of national procedures and may feed into national legislation.
The project will run for approximately 6 months.
For more information please see – https://www.nrecoffice.ie/nrec-ct/ctr-national-collaboration-project/