Read the online version | ISSN 2811-8073
  June 2024  

Clinical Trials Highlights

Updates on the ACT EU initiative, CTIS and the clinical trials landscape in the EU
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Introduction

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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). 

Final months of transition to CTR

We are now only 7 months away from the end of the 3-year transition period to the Clinical Trials Regulation (CTR). Sponsors are reminded to transition any trials that are expected to continue after 30 January 2025 from the Clinical Trials Directive to the CTR.

Sponsors should take into account the time necessary for completion of the Member State(s) evaluation procedure, which can take up to 3 months. Members States have agreed on an expedited procedure for transitioning trials to the CTR which will be applied whenever possible, as described in the CTCG Best practice guide.

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

Further resources to support sponsors transitioning trials are available on the CTIS website.

-       EMA Clinical Trials Team

ACT EU

Two new advice pilots

ACT EU launched two complementary advice pilots aimed at improving the quality of applications for clinical trials or marketing authorisation. Stakeholders can consult the guidance for applicants on the ACT EU website.
 
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Webinar for applicants to advice pilots on 17 July 2024

The webinar will provide information on the newly launched advice pilots, outlining their scope and benefits. Participants can submit questions between 24 June to 10 July 2024 via Slido, using the code #pilotsCA.
 
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Journal article describing ACT EU
An overview of the mission and benefits of the ACT EU initiative for public health is available in a new scientific article published by Nature Reviews Drug Discovery.
 
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Support for non-commercial sponsors

With input from the Clinical Trials Coordination Group (CTCG), ACT EU has identified initiatives available in each EU Member State to support non-commercial sponsors, at national, EU or global level. An interactive map of this information is available on the ACT EU website.
 
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Transparency in CTIS

Revised CTIS transparency rules

The revised rules became applicable on 18 June 2024 with the launch of a new version of the CTIS public portal. This ensures earlier and more efficient access to information about clinical trials in the EU for patients, healthcare professionals and other stakeholders. Under the new rules, over 4000 clinical trials with issued decisions are now publicly accessible through the CTIS search and going forward, approximately 500 more trials will be made public every month.
 
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Resources for sponsors on revised transparency rules
Updated materials are available to support sponsors in the implementation of the revised CTIS transparency rules, including a quick guide for users which provides a summary of what will be published when. All supporting documents can be found under the “Transparency in CTIS” section of the ACT EU website.
 
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Updated training modules

To reflect the changes introduced by the revised CTIS transparency rules and the new version of the public portal, several modules of the CTIS online training programme have been updated: Modules 02, 07, 10 and 11. The programme covers all clinical trial lifecycle stages, from submission through authorisation to supervision.
 
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CTIS events

CTIS walk-in clinic 10 July 2024
CTIS walk-in clinics allow sponsors to raise questions about any CTIS functionality and receive advice from CTIS experts. CTIS users can submit and upvote questions in advance via Slido until 3 July, with the code #clinic246.
Date
date 10/07/2024
Venue
venue Online
 
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CTIS training for sponsor users
EMA offers a virtual training programme, organised by DIA, to support sponsor user preparedness for CTIS. A hands-on approach is taken to explain and demonstrate the functionalities of the system, such as user management, how to submit an initial application as well as modifications, both substantial and non-substantial.
Date
date 23/09/2024 - 26/09/2024
Venue
venue Online
 
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CTIS development

Recent improvements in CTIS

The latest improvements include the option to update sponsor information via a non-substantial modification, changes to the publication of Notifications and the addition of a mandatory field on ‘individual participant data’ as required in the WHO Trial Registration Data Set. More details are available on the CTIS website.
 
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CTIS training

Access to CTIS training environment
Sponsors can express their interest in gaining access to the CTIS Training Environment by filling in the open survey. The training environment is a simulation of CTIS used in production and allows users to get familiar with system functionalities.
 
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ISSN: 2811-8073 | Catalogue Number: TC-AL-24-003-EN-Q