Accelerating Clinical Trials in the EU (ACT EU) was launched a few days ago, with the aim of transforming the way in which clinical trials are designed and conducted, thus increasing the attractiveness of the EU as a focal point for clinical innovation and R&D. For our clients, this initiative could pave the way for speedier marketing authorisations and lower trial costs.
ACT EU builds on the Clinical Trials Regulation (CTR) and the imminent launch of the Clinical Trials Information System (CTIS) on 31st Jan. Please see our post from October last year and our report published in European Pharmaceutical Law Review, providing an overview of the implications of the CTR and CTIS for pharmaceutical companies.
Amongst the ten priority actions set out in the ACT EU strategy paper, there is one focused on developing guidance on artificial intelligence (AI)/machine learning (ML)-impacted clinical trials, complex trials, decentralised clinical trials (DCTs) and the interface between the CTR and the In Vitro Diagnostic Medical Devices Regulation (IVDR). It’s great to see this push for innovation in European clinical trials, alongside the defragmentation efforts of the CTR and CTIS.