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

Brussels, 18 March 2025 – EORTC shares its experience in implementing new EU healthcare regulations that often have overlapping scopes but distinct requirements, posing challenges for sponsors in advancing cancer treatment.

Addressing these challenges is crucial to ensuring that cancer clinical trials can safely and effectively integrate technological advancements into healthcare systems, ultimately benefiting patients and healthcare providers alike.

In recent years, new healthcare regulations have been introduced with the aim of standardising implementation processes across 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 the CTR, MDR, IVDR, GDPR and the AIA 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. Studies focusing on quality of life, safety, and important questions like treatment optimisation or organ preservation strategies may struggle under the new regulatory environment that poses additional administrative and financial burdens, despite their potential benefits for patients and healthcare systems.

Moreover, the current normative framework in the EU is notably restrictive for AI-based innovations, particularly in healthcare and clinical trial contexts, creating hurdles that may stifle EU innovation and competitiveness, as well as delay the deployment of life-saving systems.

Today, EORTC is involved in two high-level initiatives led by the European Commission aimed at tackling the challenges in cancer research:

• the COMBINE project which aims to analyse the root causes of the challenges encountered by sponsors in conducting combined studies and identify possible solutions to these challenges,
• and ACT EU, which aims to transform how clinical trials are initiated, designed and run to further promote the development of high-quality, safe and effective medicines, and to better integrate clinical research in the European health system.

Denis Lacombe, EORTC CEO, emphasises: “We trust that sharing experiences is critical for collectively improving our ecosystems for clinical research. European initiatives such as ACT EU are central to such improvement. Working together can ensure optimal regulatory frameworks for clinical research in Europe”.

Europe’s appeal as a hub for clinical research can be strengthened by building on existing regulations and fostering an environment that supports both early and late-stage clinical research, encompassing commercial and non-commercial studies, as well as drug-focused and patient-centred research.

*The Regulation (EU) 536/2014 on clinical trials on medicinal products for human use (CTR), the Medical Device Regulation (EU) 2017/745 (MDR), the In Vitro Medical Devices Regulation (EU) 2017/746 (IVDR), the General Data Protection Regulation (EU) 2016/679 (GDPR), and the Artificial Intelligence Act of the EU (AIA).

The European Organisation for Research and Treatment of Cancer (EORTC) is a non-governmental, non-profit organisation, which unites clinical cancer research experts, throughout Europe, to define better treatments for cancer patients to prolong survival and improve quality of life. Spanning from translational to large, prospective, multi-centre, phase III clinical trials that evaluate new therapies and treatment strategies as well as patient quality of life, its activities are coordinated from EORTC Headquarters, a unique international clinical research infrastructure, based in Brussels, Belgium.

EORTC staff

Stéphanie Kromar
Head of Regulatory Affairs
stephanie.kromar@eortc.org

Rana Kassas
Legal Expert in Clinical Research
rana.kassas@eortc.org