Regulatory Beyond
beta testing
With just one year left before all ongoing clinical trials in the EU must transition to the Clinical Trials Information Systems (CTIS), marking the end of the three-year transition period since Clinical Trials Regulation came into effect in the EU, Jim Banks speaks to Lene Grejs Petersen, senior advisor, Danish Medicines Agency and Inge Christoffer Olsen of the Department of Research Support for Clinical Trials, Oslo University Hospital about the most recent updates, challenges and benefits the new regime has brought about.
he number of clinical trials in Europe has been in sharp decline. By the time of the Covid-19 pandemic in 2020, Europe accounted for 19.3% of global clinical trials activity, according to GlobalData, a decrease of more than 6.3% over a 10-year period. That number slumped even further thanks to the pandemic.
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Costly and cumbersome processes under the 2001 Clinical Trials Directive were to blame, but the European Union (EU) has since made drastic changes. As of the start of 2023, all clinical trial
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applications in the EU must be submitted through the new Clinical Trials Information System (CTIS), created by the European Medicines Agency (EMA) as part of the shift towards the new Clinical Trials Regulation (CTR).
CTR and CTIS were expected to lower the administrative burden, providing an easier, more streamlined approach to trial registration. This was music to sponsors’ ears. “In my opinion, it really is a good change,” says Inge Christoffer Olsen, Department of Research Support for Clinical Trials,
Clinical Trials Insight /
www.worldpharmaceuticals.net
elenabsl; bearsky23/
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