From rigid to rapid: rethinking clinical trial processes for emergency-ready clinical trials

Abstract

In July 2025, the European Commission (EC) set a goal to make Europe the most attractive place for life sciences by 2030 [1]. Important initiatives like Accelerating Clinical Trials in the European Union (ACT-EU), a joint initiative by the European Medicines Agency (EMA), the EC and the Heads of Medicines Agencies (HMA), aim to achieve that ambition by creating a harmonized and attractive environment for multinational clinical research [2]. Yet in practice, investigators still face high regulatory, ethical and administrative burdens [3], and Europe does not appear to keep up with the growth in clinical trial starts seen in other regions globally [4]. Even when hurdles in trial initiation are overcome, challenges remain: up to one-third of clinical trials are terminated prematurely, primarily due to operational issues such as poor enrolment [5]. It is a serious issue when valuable public resources are used for well-designed trials addressing important research questions, only for those to fail to deliver results. This is an even larger problem during infectious disease outbreaks, as epidemiology evolves rapidly and timeliness is an important determinant of the impact of interventions. This speed dependency sharply contrasts with the widely recognized rigid and time-consuming clinical trial processes, making it difficult to steer effective public health responses in real time.