EFPIA statement on EMA's "Accelerating Clinical Trials in the EU (ACT EU)" initiative

EFPIA welcomes the European Commission, the Heads of Medicines Agencies and the European Medicines Agency's initiative Accelerating Clinical Trials in the EU (ACT EU). The project aims to transform how clinical trials are initiated, designed and run in Europe bringing together regulators and other stakeholders (patients, academia, Health Technology Assessment bodies and payers). With the implementation of EU Clinical Trials Regulation (CTR) and Clinical Trials Information System (CTIS) going live by 31 January 2022, it represents the beginning of an exciting new phase for clinical research in Europe.
Clinical trial designs are becoming more innovative, leading to greater efficiencies, and allowing a more patient-centric approach encompassing patient diversity. Many traditional processes are taking on new formats to increase clinical development efficiencies, such as innovative complex clinical trial designs(1), Artificial Intelligence and machine learning impacted clinical trials (CTs), decentralised CTs and In Vitro Diagnostic Medical Devices Regulation (IVDR)/CTR interface (to strengthen links between innovation and scientific advice fora) and digitalisation offering greater potential for patient monitoring and data generation.

EFPIA calls upon all stakeholders to embrace the ACT EU initiative and changes needed to strengthen clinical research in Europe.

(1) For more information see the outcome of the multi-stakeholder workshops Accelerating Adoption of Complex Clinical Trials in Europe and beyond, October 2021.