As Clinical Trials in Europe prepare for major changes, what next for the research process? Des McMahon, VP Regulatory Affairs and Quality Assurance, G&L Scientific, discusses the implications.
Clinical trials in Europe will undergo sweeping changes at the start of 2022 with the introduction of new regulations aimed at streamlining the research process.
When it goes live on January 31, the Clinical Trials Information System (CTIS) will centralize the submission, assessment and supervision procedures for clinical trials throughout the EU and the European Economic Area (EEA).
Currently, sponsors must submit separate applications for clinical trials to each national authority within the EU. These are then sanctioned by the relevant ethics committee in each country for approval before a trial can run.
Once live, CTIS will revolutionize the experience by allowing sponsors to apply for trial authorization in up to 30 countries with a single application.
The system is enhanced by its utilization of the European Medicines Agency’s (EMA) IT tools. This move will provide fully coordinated and harmonized safety reporting for trials across the EU and will be essential in the sharing of information relaying the benefits and risks of medicinal products throughout the region.
An additional benefit of the new streamlined arrangement will be its ability to easily facilitate the expansion of trials to other EEA countries through improved collaborations and knowledge-sharing across borders.
CTIS will also improve transparency and access to information through the implementation of a public website containing detailed information on the outcomes of all clinical trials conducted in the EU.
The changes are far-reaching and, by impacting positively on efficacy and safety rates, will make the EU an attractive region for pharmaceutical firms and their vital clinical research.
The move also has the potential to make Northern Ireland (NI) an attractive proposition for trials as it is covered by European Law through the NI Protocol as of January 2021.
Of course, as dramatic as these changes appear, they won’t happen overnight and will take time to come to fruition. In fact, there will be a three-year transition period before they become fully operational.
For the first twelve months, applicants can submit their application either via the current Clinical Trials Directive or the new Clinical Trials Regulation. As of January 2023, submission by Clinical Trials Regulation becomes mandatory with all ongoing trials transitioning to the new Regulation and CTIS by January 2025.
Although they may not seem quite as immediate as they first appear, there is no question that big changes are afoot across the EU regarding clinical trials. To help ensure the transition is as seamless as possible, the EMA has developed an extensive training programme to assist sponsors, authorities and ethics committees as they prepare for CTIS.
Changes are coming and will undoubtedly benefit efficacy rates across the EU. How the corresponding authorities like the MHRA and FDA respond and react to them will be hugely interesting, but we can be certain that clinical trials will never be the same again.
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