Read the online version | ISSN 2811-8073

September 2023

Clinical Trials Highlights

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

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Introduction

Update from ACT EU team

ACT EU

CTIS development

CTIS training

CTIS events

General Updates

Introduction

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).

Update from ACT EU team

Welcome to the September 2023 issue of the Clinical Trials Highlights.

The ACT EU website is now live, providing information on the ongoing activities for smarter clinical trials through regulatory, technological and process innovation. The website will be a key resource on clinical trials in the EU for patients, sponsors and regulators. We would be happy to receive any feedback on the website via the available contact form.

One of the priorities of ACT EU is to monitor the implementation of the Clinical Trials Regulation (CTR) and the operation of the related Clinical Trials Information System (CTIS). Since the launch of CTIS on 31 January 2022, over 2100 initial clinical trial applications have been submitted and over 1000 clinical trials have been authorised under the CTR.

Sponsors are already preparing for the next phase of implementation of the CTR. By 30 January 2025, any ongoing trials approved under the previous legal framework, the Clinical Trials Directive, will fall under the CTR. Therefore, any trials will need to be transferred to CTIS and approved by 30 January 2025 if they are ongoing. Sponsors have already submitted over 300 transitional trials to CTIS.

The European Medicines Regulatory Network continues to support sponsors in the transition of their ongoing trials via dedicated events, training material and guidance documents. Key information and relevant materials are available in a new section of the CTIS website.

ACT EU

Launch of the ACT EU website

A dedicated website has been launched on the ACT EU initiative, co-led by the European Commission, HMA and EMA. The website contains key resources, latest news and upcoming events, including updates on the Multi-stakeholder platform, the implementation of the CTR, and information on scientific advice procedures such as the Simultaneous national scientific advice (SNSA) pilot.

Multi-stakeholder platform: kick-off meeting report

A first multi-stakeholder platform workshop was held in June 2023, to understand different stakeholder perspectives on how to transform the EU environment for clinical trials and agree on a model for the establishment of the platform. The summary report of the workshop is now available on the ACT EU website.

Clinical trial methodology workshop 23 November 2023

ACT EU is hosting a multi-stakeholder methodology workshop on 23 November 2023. The focus will be on key topics proposed by stakeholders, to discuss the status of methodology guidance documents and assess the need for new or revised guidance. A call to register and propose discussion topics concluded on 17 September 2023. A detailed agenda will be published in due course.

Outcome of the ICH E6 R3 workshop on 13-14 July 2023

The virtual workshop was attended by around 1000 relevant stakeholders, including patients, healthcare professionals, assessors, inspectors, industry and academia. A summary report of the outcomes is available on the event page.

CTR implementation: Revised KPI report

A revised monthly report on the implementation of the CTR will soon be available on the ACT EU website, with Key Performance Indicators on clinical trials (CTs) transitioned from the Clinical Trials Directive to CTR. Data on the EudraCT database, which is no longer in use for submitting new CT applications (while still in use for ongoing CTs and posting of results), will no longer be reported.

CTR implementation: Survey of sponsor users

Following the survey led by the European Commission's Directorate-General for Health and Food Safety (DG SANTE) in 2022, sponsor users with clinical trials with a decision in CTIS have now been invited to fill in a follow-up survey to monitor the implementation of the CTR and CTIS use. The feedback will be analysed to identify solutions that will further support sponsors in implementing the CTR.

Clinical trials in public health emergencies

The scope of ACT EU has been expanded to include activities enabling multinational clinical trials in the EU during public health emergencies. This will tackle different aspects of the regulatory approval process to enable large trials by increasing collaboration across regulators and ethics committees, and the role of the EMA Emergency Task Force in fostering alignment across Member States.

CTIS development

Recent improvements in CTIS

Latest improvements include a faster, more reliable search for organisations in the Organisation Management Service (OMS) via CTIS and other enhancements in the preparation of documents, authorisation and supervision of trials. More details on recent improvements are available on the CTIS website.

Transparency rules in CTIS

The public consultation on the CTIS transparency rules, which was launched on 3 May 2023, concluded on 28 June 2023. Over 200 responses were received from CTIS users and stakeholders. The feedback reflects diverse views on the use of deferrals and redaction functionalities, with agreement on the need for simplification.

CTIS training

Revised guidance on transitioning trials

The CTCG has published revised versions of the Best Practice Guide and cover letter template for sponsors transitioning multi-national clinical trials to the Clinical Trials Regulation / CTIS, available under news and events on the group's webpage.

Updated CTR Quick guide for sponsors

The European Commission has published a new version of the CTR Quick Guide for sponsors. This revised version includes clarifications on how to submit the IMPD-Q on the manufacturing of the Investigational Medicinal Product in case this is done at a decentral point of care, at one of the clinical trial sites in the additional Member State.

Access to CTIS Training Environment

Sponsors may express their interest in accessing the CTIS training environment via an open survey, which collects information to identify the needs and intention for use of CTIS and support decisions on granting access to the CTIS Training Environment. Access will expire after 6 months to allow as many sponsors as possible to benefit from the training environment.

CTIS events

Recent and upcoming CTIS events

EMA and the EMRN continue to provide training events and information sessions to support CTIS users. All EMA-run events are live broadcast and a video recording is made available after each session on the respective event pages.

General Updates

Open consultations

Interested stakeholders are invited to provide their feedback in the following open consultations:

On the ICH reflection paper on proposed international harmonisation of real-world evidence (RWE) terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of medicines, until 30 September 2023.
On the draft reflection paper outlining considerations on single-arm trials that are submitted as pivotal evidence for establishing efficacy in marketing authorisation applications, until 30 September 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, until 31 December 2023.

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ISSN: 2811-8073 | Catalogue Number: TC-AL-23-002-EN-Q