Navigating EU clinical trials: Adapting to a new era of regulations

Abstract

In recent years, new healthcare regulations have been introduced in the aim of standardising implementation processes across European Union (EU) member states, while maintaining high ethical and scientific standards for healthcare innovation. In clinical research, the simultaneous application of multiple EU regulations to clinical trials poses significant challenges. The interplay between these regulations’ requirements is explored. These regulations often overlap in scope but differ in requirements, creating compliance complexities for healthcare stakeholders in general, and for sponsors of clinical trials in particular. Clinical research programs aimed at optimising treatment for patients may struggle under the new regulatory environment that poses additional administrative and financial burdens, despite their potential benefits for patients and healthcare systems. Addressing these challenges is crucial to ensuring that clinical trials can safely and effectively integrate technological advancements into healthcare systems, ultimately benefiting patients and healthcare providers alike. Coordinated efforts to navigate differing workflows for trials involving both drugs and devices are being addressed at a pan-European level. Today, the European Organisation for the Research and Treatment of Cancer (EORTC) is involved in two high-level initiatives led by the Commission aimed at tackling the challenges in cancer research.