ACT EU multi-stakeholder meeting on decentralised clinical trials
EventHumanClinical trials
Date
- Tuesday, 04 October 2022, 09:30 (CEST) - 13:30 (CEST)
Location
- OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
Event summary
The Accelerating Clinical Trials in the EU (ACT EU) programme is hosting a multi-stakeholder workshop on decentralised clinical trials (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.
DCTs introduce new approaches to the conduct of clinical trials that aim to make clinical trials more easily accessible and convenient for participants to take part in.
The DCT methodology is based on, for example, home health visits, direct to patient shipment of study drugs and electronic informed consent.
During the workshop, the EU DCT project group will present the work of the European medicines regulatory network on decentralised clinical trials collaboration, including the planned publication of a recommendation paper on the use of decentralised elements in clinical trials in the fourth quarter of 2022.
The workshop will include breakout sessions with an opportunity for shared discussion on topics of relevance to DCTs.
Core members of the EU DCT project team will facilitate these sessions. They include:
- clinical trial experts from the Clinical Trials Coordination Group (CTCG);
- ethical experts from the Commission Expert Group on Clinical Trials (CTEG);
- good clinical practice (GCP) inspectors from theGood Clinical Practice Inspectors Working Group (GCP IWG)
The workshop aims specifically to bring forward the perspective of patient representatives and investigator site experts.