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). 

Welcome to the December 2024 issue of Clinical Trials Highlights.

We are now seven weeks away from the end of the transition period to the Clinical Trials Regulation (CTR). By the end of October 2024, sponsors have transitioned over 4,590 trials from the previous legal framework, the Clinical Trials Directive (CTD), to the CTR. We have seen a significant increase in the last few months, with over 860 trials transitioned in October alone.

Some trials have still not been transitioned. We strongly advise sponsors to act now to ensure that any trials that are expected to continue after 30 January 2025 are submitted to the Clinical Trials Information System (CTIS) as soon as possible, in compliance with the CTR. Sponsors can find guidance and instructions on how to transition trials on the CTIS website. Academic sponsors can request additional support via the helpdesk for non-commercial sponsors.  

Ongoing clinical trials that have not transitioned to the CTR by 30 January 2025 will be considered non-compliant with the Regulation, as highlighted in the European Commission’s guidance on transition.

The European Medicines Regulatory Network is working together to support sponsors in the final months of the transition period. Under ACT EU we are also looking to the future to ensure further harmonisation of processes in line with stakeholders’ needs, aiming to improve the clinical trials landscape in the EU. 

- Marianne Lunzer
CTCG chair, Austrian Medicines and Medical Devices Agency

An interim report is available on the European medicines regulatory network's experience with analysing patient-level clinical study data submitted voluntarily by marketing authorisation applicants and holders as part of a pilot. This report offers preliminary insights into the regulatory benefits of including clinical study data in the marketing authorisation application dossier, potentially leading to earlier opinion and authorisation of medicines.

Based on the initial findings, the pilot has been extended until further notice. Interested stakeholders can request to participate by writing to rawdatapilot@ema.europa.eu.

Use of clinical study data in medicine evaluation (EMA website)

Partners and stakeholders can provide their input on the draft data strategy for the European Medicines Regulatory Network (EMRN) by 31 December 2024, through an online questionnaire.

The strategy aims to enable maximising the use of data hosted by the regulatory network. It ensures that data is appropriately organised, standardised, of high-quality and easily shareable among regulators and stakeholders to facilitate collaboration and informed decision-making on medicines.  

For more information, see Big data (EMA website)

EMA in collaboration with BfArM and the EMA Methodology Working Party is organising a webinar to provide an introduction to the estimand framework (ICH E9 addendum), with break-out sessions on the application of the framework in different disease areas (oncology, central nervous system, dermatology).

Clinical and statistical assessors from national competent authorities can register to participate on their preferred date, 22 January or 17 February 2025. Participants can also register to the break-out session of their choice via the survey linked in the course description. Registration is open until 8 January 2025.

The EMA is moving towards Bring Your Own Identity (BYOI) authentication capabilities, to improve security and usability of EMA applications. BYOI allows email address authentication for EMA applications, removing the need for users to remember their EMA username and password. From 30 September 2024 all new users will be automatically set to authentication using email address and all existing users will be prompted to opt in. 

More information can be found in the recordings of the EMA public system demo, the EMA Account Management, What’s new webinar and the EMA Account Management dedicated page.