Clinical Trials Highlights

This newsletter provides the latest news on clinical trials from the European Medicines Regulatory Network (EMRN), including news on the joint Accelerating Clinical Trials in the EU (ACT EU) initiative and on the Clinical Trials Information System (CTIS). 

The Clinical Trials Coordination Group (CTCG) is a key actor in achieving ACT EU’s vision of seamless coordination between regulators, ethics committees and impacted stakeholders, to deliver more impactful clinical trials for the benefit of EU public health.

As vice-chair of the CTCG since May 2023,  I have had the opportunity to contribute to key CTCG activities aiming to improve the clinical trial landscape in Europe:  

• Clarifying and simplifying the rules for transition of clinical trials from the Directive to the Clinical Trials Regulation (CTR);
• Establishing the CTR COLLABORATE project to develop effective assessment and supervision procedures for clinical trials, with close collaboration between and within Member States involving national competent authorities and Ethics Committees;
• Many ACT EU activities including training and supporting Member State preparedness in public health emergencies.

I have also been driving the initiative for an EU Forum for ethics committees involved in the assessment of clinical trials under the CTR, in collaboration with colleagues from ethics bodies in Denmark and Germany and the European Commission. Our goal is to strengthen the cooperation between EU Ethics committees in the EU, facilitate the exchange of experience, align best practices and provide training.

- Monique Al, CTCG vice-chair

Member State’s competent authorities for clinical trials and medical devices and the European Commission have published information on the "COMBINE" project, which addresses the challenges at the interface between the Regulations on clinical trials of medicinal products, medical devices and in vitro diagnostics.

Interested stakeholders are invited to provide their feedback until 31 December 2023 on the draft reflection paper on the use of artificial intelligence (AI) to support the safe and effective development, use and regulation of human and veterinary medicines.

Applicants or marketing authorisation holders (MAHs) that are planning to submit an initial or post-authorisation marketing authorisation application to EMA during the first quarter of 2024 are still welcome to express their interest to participate in the proof-of-concept pilot by writing to rawdatapilot@ema.europa.eu.

The pilot collects practical learnings on operational, resource and technological aspects from all stakeholders involved in the pilot including CHMP. Initial insights will be gathered into an interim pilot report, a summary of which is expected to be published in early 2024.

The pilot recently selected its fifth regulatory procedure and reached the halfway point in its journey to test the role of analysis of clinical trials ‘raw data’ submitted to EMA in electronic structured format. The last selected procedure relates to an initial marketing authorisation application in gastroenterology.

Further information is available on EMA’s Big Data webpage.