Read the online version | ISSN 2811-8073
  April 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). 

Transparency in CTIS

Welcome to the April 2024 issue of Clinical Trials Highlights.

The revised CTIS transparency rules will become applicable on 18 June 2024, following their adoption by the EMA Management Board in October 2023. 

The updated rules strike a balance between transparency of information and protection of commercially confidential information. They benefit patients, ensuring key clinical trial information, that patients flagged as being most relevant for them, is published early. They also introduce process simplifications that benefit clinical trial sponsors who have to protect commercially confidential information and personal data.

Sponsors are advised to adapt their business processes to align with the revised rules. More information and resources are available on the ACT EU website.

The European Medicines Regulatory Network (EMRN) continues to work to support sponsors and ensure the successful implementation of the CTR, aiming to improve the EU environment for clinical trials.

-       EMA Clinical Trials Team

ACT EU

Multi-stakeholder platform Advisory Group established

The first meeting of the MSP Advisory Group on 20 March 2024 officially launched the ACT EU Multi-stakeholder platform (MSP). The establishment of the MSP is a key milestone for the ACT EU initiative, as it provides a channel for stakeholders to exchange views and voice priorities on various aspects of clinical research.
 
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Consolidated advice pilots

In Q2 2024, ACT EU is launching two pilots offering: a) harmonised scientific advice to support the submission of marketing authorisation and clinical trial applications (CTAs) in the EU, and b) consolidated technical/regulatory advice on CTA dossiers prior to their submission in CTIS.
 
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Outcome of SNSA training webinar
The new pilots complement the existing pilot on National Scientific Advice (SNSA). On 19 April, over 1100 viewers followed a webinar hosted by ACT EU and the EU Innovation Network, providing information on the ongoing SNSA pilot and how it can be used, highlighting benefits for applicants, and answering their questions. A video recording will be available on the event page in due course.
 
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Report of clinical trial analytics workshop

The ACT EU workshop on 25-26 January 2024 highlighted a collective ambition to improve the use of data about clinical trials, with a multi-stakeholder approach to identify research priorities. This will speed up the development of an analytics ecosystem that maximises health benefits for EU citizens. A report summarising the discussion has been published on the ACT EU website.
 
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Report of methodology workshop

The ACT EU multi-stakeholder workshop on methodology guidance facilitated discussions on key topics of clinical trial methodology in order to identify the challenges, propose ways for improving patient centricity and suggest possible solutions. An outcome report has been published, summarising the discussions in all the break-out sessions and identifying common themes.
 
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Summary gap analysis of assessor training needs
As part of the work to deliver a clinical trials training curriculum, ACT EU worked with stakeholders from the regulatory network to identify the training needs of assessors of clinical trials. A summary of the gap analysis has been published on the ACT EU website.
 
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CTIS development

Recent improvements in CTIS

The latest improvements include enhancements in the authorisation and supervision of trials; collaboration between Member States on ad-hoc/safety information; communication between sponsors and Member States; display of trial sites in saved/submitted applications. More details on recent improvements are available on the CTIS website.
 
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CTIS training

Updated guidance for sponsors transitioning trials to CTR

Sponsors transitioning their ongoing trials from EudraCT to CTIS may now consult the updated guidance documents from the European Commission and CTCG. All materials from the European Medicines Regulatory Network are available on the CTIS website, under the section “Transitioning Trials”.
 
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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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CTIS events

CTIS bitesize talk 24 April 2024
This CTIS bitesize talk aims to provide sponsors with information on alternate Investigational Medicinal Product Dossier – Quality (IMPD-Q) and new guidance on Auxiliary Medicinal Products (AxMP).
Date
date 24/04/2024
Venue
venue Online
 
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CTIS walk-in clinic 15 May 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 8 May, with the code #clinic245.
Date
date 15/05/2024
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 10/06/2024 - 13/06/2024
Venue
venue Online
 
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General Updates

Open consultation until 31 May 2024

Interested stakeholders are invited to provide their feedback until 31 May 2024 on the concept paper on the development of a guideline on non-inferiority and equivalence comparisons in clinical trials. Comments should be provided using this EU Survey form.

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ISSN: 2811-8073 | Catalogue Number: TC-AL-24-002-EN-Q