A clearer harmony and attractiveness for EU Clinical Trials Regulation
EU Clinical Trials Regulation (EU CTR) has been a hot topic for a little while now. An initiative launched by the European Commission, EMA, and national regulators within the EU in 2022 in order to change the way clinical trials are designed and run, so as to position Europe as an area of clinical trial excellence internationally, via a harmonised strategy between member states – the deadline for sponsors to transition ongoing trials to EU CTR comes into effect in January 2025.
So it was that for the latest episode of the pharmaphorum podcast web editor Nicole Raleigh sat down with Chris Bamford, director of clinical trial regulatory management at IQVIA, and Shirley Rutter, associate director and strategic quality lead of global quality management at IQVIA Biotech, to find out how industry is dealing with that transition.
Bamford notes that clinical trials within the EU have had a mixed history of positivity. Before 2004, indeed, every country in the EU had a totally different regulatory environment for clinical trial management. Then, 2006’s EU Clinical Trial Directive brought some harmony, but not with enough consistency.
A clearer harmony and attractiveness for sponsors are key considerations embedded in the current EU CTR. The new regulation permits a single submission through a central portal across the whole of the EU, but an extensive process of rethinking has been necessary to adapt to that. It has, Rutter admits, been a challenging and significant reset, with extensive planning – and more upfront planning – required alongside the usual agility.
Nonetheless, a considerable number of resources and guidance are available, including training and monthly drop-in calls, and webinars to answer questions. The EMA has been incredibly engaged, says Bamford.
Although in the third year of the transition window, for smaller biotech companies open collaboration with each functional stakeholder internally – especially regulatory and start-up teams and sponsors – is critical, as is alignment.
You can listen to episode 117a of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series - in iTunes, Spotify, acast, Stitcher, and Podbean.