Read the online version | ISSN 2811-8073

July 2023

Clinical Trials Highlights

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

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Introduction

A view from the EU Network

ACT EU

CTIS development

CTIS events

CTIS training

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).

A view from the EU Network

Welcome to the July 2023 issue of Clinical Trials Highlights.

We are now mid-way through the transition period of the Clinical Trials Regulation (CTR), 18 months after the launch of the Clinical Trials Information System (CTIS). In total, over 1700 initial clinical trial applications have been submitted in CTIS and over 700 clinical trials (CTs) authorised under the CTR are available in the system.

Building on the CTR, the vision of the ACT EU initiative is to make the EU more attractive for clinical research. ACT EU aims to enable more impactful, fit for purpose CTs, with seamless coordination among regulators and impacted stakeholders. The initiative envisions smart CTs through regulatory, technological and process innovation. The new clinical trial ecosystem will foster collaboration by empowering, engaging and supporting stakeholders to deliver better medicines to patients.

As part of the initiative, the kick-off meeting of the ACT EU multi-stakeholder platform took place in June, with broad participation from sponsors, regulators, including ethics committees, academia, patients and healthcare professionals. A series of workshops are planned in 2023 and 2024 to establish the platform and further discuss identified priorities.

Better clinical trials bring medicines to patients faster. We are strongly committed to working with stakeholders towards an excellent environment for CTs in Europe, with smarter, more impactful CTs that deliver high quality clinical evidence for better public health.

Bjorn Eriksson
Director General
Swedish Medical Product Agency

ACT EU

Feedback from kick-off meeting of the multi-stakeholder platform

With a view to understand different stakeholder perspectives on how to transform the EU environment for clinical trials, the kick-off meeting of the multi-stakeholder platform (MSP) took place on 22 and 23 June 2023.

Upcoming sponsor survey on CTR implementation

The follow-up sponsor survey on the CTR implementation is foreseen to be launched in September 2023.

Update on the ICH E6 R3 Workshop on 13-14 July 2023

Following the revision of the ICH E6 R2 guideline on Good Clinical Practice (GCP) that aims to address the application of GCP to the increasingly diverse range of clinical trial types and data sources, ACT EU Priority Action 4 on GCP Modernisation held a Workshop on the ICH E6 R3 Public Consultation (principles and Annex 1) on 13 and 14 July 2023.

Overarching methodologies workshop on 22-23 November 2023

With a view to progress the alignment process and ensure stakeholder needs are recognised and incorporated, an on-site multi-stakeholder Methodology Workshop will be held on 22-23 November 2023. The focus will be on discussing key topics related to Methodology guidance, with the aim to identify guidance needs and to propose scopes.

Open consultation on single-arm trials reflection paper

As previously announced, a reflection paper has been drafted to outline considerations on single-arm trials that are submitted as pivotal evidence for establishing efficacy in marketing authorisation applications. The reflection paper remains open for public consultation on the EMA website. Stakeholders are invited to send their comments by 30 September 2023.

CTIS development

CTIS now a registered WHO data provider

Data from authorised trials published on the CTIS website - excluding those with deferrals - is now included in the search portal of WHO’s International Clinical Trials Registry Platform (ICTRP). This applies to relevant clinical trial data, as required by WHO, which has been published on CTIS since the launch of the system on 31 January 2022.

Move of CTIS User Service to ServiceNow platform

In alignment with the EMA’s information security strategy, a new IT service management solution called ServiceNow will replace the current tool (JIRA) for CTIS User Support Service (USS) requests, starting on 31 July 2023.

Recent improvements in CTIS

Latest improvements include the implementation of multi-factor authentication to enhance security of user accounts; the migration to high availability infrastructure to enhance system performance; and the enhancement of the WHO API to improve the process of data extraction from the CTIS public portal. More details on recent improvements are available on the CTIS website.

Guidance on protection of personal data and CCI in CTIS – final document published

The final guidance document on the protection of personal data and commercially confidential information while using the current transparency rules for CTIS is now available on the EMA website, including chapter 4 on protection of CCI and chapter 5 on GCP inspection reports.

Review of CTIS transparency rules

The public consultation on the CTIS transparency rules, which was open from 3 May to 28 June 2023, is now concluded. EMA is currently reviewing the comments received, with the aim of publishing a concept paper with the proposed simplified transparency rules later this year.

Transitional Trials: dedicated workshop and updated CTCG guidance

In collaboration with the Member States and the European Commission, EMA held a Workshop on 5 July 2023 on the joint actions for transitioning ongoing trials to the Clinical Trials Regulation.

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.

CTIS training

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 a limited time period (6 months) to allow as many sponsors as possible to benefit from the training environment.

General Updates

ICH M11 Scientific guideline

The purpose of this draft ICH guideline is to introduce a clinical protocol template and a technical specification to ensure that protocols are prepared in a consistent fashion and enable an harmonised data exchange format acceptable to the regulatory authorities.

Following the end of the public consultation period on the ICH M11 scientific guideline in the EU, an overview of comments received has been published. More information is available on the ICH website.

Building on work products of ICH M11, project Vulcan by HL7 Vulcan and CDISC aims to create an accelerator dedicated to connecting clinical and transnational research to clinical care through Fast Healthcare Interoperability Resources.

Clinical Trials Raw Data Proof-of-Concept pilot continues

Are you interested in participating in a pilot assessing benefits of access to clinical trials raw data? The clinical trials raw data proof-of-concept pilot has now selected its third and fourth regulatory procedures to help assess the benefits and practicalities of access to raw data in the assessment of medicines.

The procedures will entail a type II variation application in the area of oncology and a variation application in the area of dermatology.

EMA welcomes expressions of interest from applicants or Marketing Authorisation Holders (MAHs) that are about to submit a marketing authorisation application or post-authorisation application, who can participate in the pilot by contacting rawdatapilot@ema.europa.eu.

Participation in the pilot offers a unique opportunity to applicants and MAHs to contribute to the pilot’s learnings which will, in turn, assist the EU medicines regulatory network to make an informed decision on the place of raw data in regulatory decision-making. Pilot related guidance for applicants and MAHs can be found on EMA’s Big Data webpage.

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ISSN: 2811-8073 | Catalogue Number: TC-AL-23-001-EN-Q