Interesse for on-site deltagelse i ACT EU-workshop om Vejledning i Decentraliserede Kliniske Forsøg d. 4. oktober 2022 – Deadline for anmodning om deltagelse er 6. september 2022.

25. august 2022

Som led i det europæiske arbejde for at sikre bedre rammer om innovativ klinisk forskning, er der igangsat et europæisk projekt for decentraliserede elementer i kliniske lægemiddelforsøg (EU DCT). Projektet er en del af et europæisk initiativ der skal styrke det kliniske forskningsmiljø i EU (Accelerating Clinical Trials in the EU – ACT EU), der blev startet samtidig med implementeringen af Forordningen for Kliniske Forsøg med Lægemidler (EU) No 536/2014 (CTR).

Lægemiddelstyrelsen (DKMA) står for projektledelse af EU DCT projektet, og viderebringer her invitation til anmodning om deltagelse i ACT EU’s on-site workshop d. 4. oktober 2022. On-site workshoppen bliver holdt hos EMA i Amsterdam og selve anmodningen om deltagelse sker via spørgeskema (fristen for anmodning er d. 6. september 2022). I kan også læse om workshoppen på EMAs egen hjemmeside.

New and innovative clinical trial designs and methodologies provide opportunities and challenges for the EU clinical trials environment. The EU decentralised clinical trials (EU DCT) project aims to address some of these challenges, in line with the European Medicines Agencies Network Strategy to 2025 and European Commission’s Pharmaceutical Strategy for Europe.

In order to facilitate innovation and at the same time ensure safety, dignity and well-being of the trial participant, a cross-disciplinary project group consisting of amongst others clinical trial authorisation experts, ethical experts and Good Clinical Practice (GCP) inspectors across Member States are coming together to develop a harmonised decentralised clinical trial approach from the European Medicines Regulatory Network including ethics committee representatives.

Since March 2022, the Clinical Trials Coordination Group (CTCG) under the Heads of Medicines Agencies (HMA) have been responsible for the project management of the EU Decentralised Clinical Trials (EU DCT) project, with Ditte Zerlang Christensen of the Danish Medicines Agency (DKMA) as the project manager.

The EU DCT project is part of the priority actions conducted in the context of the Accelerating Clinical Trials in the EU (ACT EU), which started at the same time as the launch of the Clinical Trials Information System (CTIS) and the implementation of the Clinical Trials Regulation (EU) No 536/2014 (CTR).

The ACT EU Programme will host a multi-stakeholder workshop on DCTs on behalf of the EU DCT project, bringing together participants from all areas of the research community to share perspectives on this type of clinical trials. The multi-stakeholder workshop will be an onsite meeting hosted by EMA on October 4th 2022. A live broadcast of the workshop’s plenary session will be provided, open to all interested parties.

During the workshop, the EU DCT project group will present the current state of their work targeting the publication of a recommendation paper on the use of decentralised elements in clinical trials at the end of Q4 2022. The workshop will include breakout sessions facilitated by the EU DCT project group providing an opportunity to engage in discussion on specific topics to shape the regulatory frameworks for DCT in the EU, including challenges within different subject areas with the purpose of identifying appropriate risk mitigations and risk-based approaches.

The cross-disciplinary EU DCT project group consists mainly of clinical trial authorisation experts, ethical experts and GCP inspectors across Member States, thus representing the perspectives of the Clinical Trials Coordination Group (CTCG), the Clinical Trial Expert Group CTEG) and the GCP Inspectors Working Group (GCP IWG). However, the project represents a broad collaboration across the European Medicines Regulatory Network and additional contributions are provided by volunteering members of the Scientific Advice Working Party (SAWP), the Methodology Working Party (MWP), the Paediatric Committee (PDCO), the European Network of Paediatric Research at the EMA (Enpr-EMA), the Patients' and Consumers' Working Party (PCWP), and the Healthcare Professionals' Working Party (HCPWP).

Onsite participants at EMA will be able to attend the plenary sessions and breakout sessions. As onsite participation is limited, however, each organisation is requested to limit the number of nominated participants to two at the most and prioritise staff with knowledge of the DCT area. The final decision on participants will be based on creating a diverse audience to facilitate discussion.

It is our pleasure to invite you to express your interest for onsite participation by completing this survey. The deadline for responses is 06 September 2022 at midnight CET. Decision on participation will be provided shortly after this deadline.

Please note that this event will be recorded. The recording, or parts thereof, may be used/published on the EMA website after the event for training and communication purposes. By participating in this event, you consent to this recording and the processing of your personal data by EMA in accordance with Regulation (EU) 2018/1725.

For information on the processing of personal data, please refer to the General EMA Privacy Statement and the EMA Privacy Statements on the organisation of meetings and events.

The agenda of the workshop will be as follows (all times are in CET):

Time

Topic

09:30 – 10:00h

Welcome

10:00 – 11:15h

Sponsor and authority perspective

11:15 – 11:30h

Break

11:30 – 13:00h

Patient and investigator site perspective

13:00 – 14:00h

Lunch Break

14:00 – 16:00h

Break-out sessions

16:00 – 16:30h

Break

16:30 – 16:50h

Feedback break-out sessions

16:50 – 17:00h

Closing remarks

Times are indicative.

 

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