The programme aims to establish a Multi-stakeholder platform (MSP), which will function as a vehicle for clinical trials stakeholders and regulators to come together, voice their views and collaborate to improve the clinical trials environment for European patients and citizens.
The MSP will provide the opportunity for stakeholders to exchange views and enable dialogue with regulators through:
1. the creation of a MSP Advisory Group;
2. multi-stakeholder events;
3. consultations, surveys, and other tools to gather stakeholders' feedback.
MSP Advisory Group
The MSP Advisory Group (MSP AG) is composed of representatives from key stakeholders who provide:
- strategic advice regarding the ACT EU workplan, identifying stakeholder priorities;
- operational advice for ACT EU initiatives, identifying experts and engagement methodology.
The full composition is available on the page MSP AG members
This document outlines the MSP Advisory Group’s mandate and rules of procedures.
MSP Advisory Group meetings
For information on upcoming and past meetings of the MSP AG, including meeting materials, see below.
- Agenda
- Presentation - MSP AG report on the most frequently reported and major issues -D.Lacombe (EORTC), A. Zanoletty (EMA), T. El-Galaly (EMA)
- Presentation - Report from CTR Collaborate stakeholder meeting held on 11 September - M.Lunzer (CTCG)
- Presentation - Discussion on stakeholder priorities to advise ACT EU Steering Group - A.Zanoletty (EMA), L.Pioppo (EMA)
- Presentation - Approach to consulting academic stakeholders - A.Zanoletty (EMA)
- Presentation - New CTIS Public Portal functionality -F.Scotti (EMA)
- Presentation - Short, medium, long term actions proposed by Industry trade associations
- Agenda
- Meeting highlights
- Presentation - ACT EU workplan and deliverables - A. Zanoletty (EMA), L. Pioppo (EMA)
- Presentation - Paediatric patients involvement in the drug development - B. Nafria (eYPAGnet)
- Presentation - Low-intervention clinical trials - S. Kromar (EORTC)
- Presentation - Limited Scientific advice for academic developers - D. Coppens (KWF)
- Presentation - Innovative Study Designs in Paediatrics - D. Bonifazi (TEDDY)
- Presentation - Enhancing and harmonizing Regulatory process for clinical trials- M. Heath (Vaccines Europe)
- Presentation - Enabling CTIS Public Data Use - F. Sweeney (CDDF)
- Presentation - CTA review process and CTR implementation - L. Leyens (EFPIA)
- Presentation - Challenges in performing mult-country Investigator Initiated Trials in EU - M. Zuidgeest (UMC Utrecht)
- Presentation - Challenges and possible options when designing a Platform Trial - F. Houyez (EURORDIS)
- Minutes
- Presentation - ACT EU workplan and key priorities: expected contribution from MSP AG - A. Zanoletty (EMA)
- Presentation - Mandate and rules of procedure of the MSP Advisory Group - O. Ademi (EMA)
- Presentation - Conclusions and next steps – forward planning of the meetings - O. Ademi (EMA)
- Agenda
- Minutes
- Table of Actions
- Presentation - ACT EU workplan and key priorities: expected contribution from MSP AG - P. Arlett (EMA)
- Presentation - Mandate and rules of procedure of the MSP Advisory Group - A. Zanoletty (EMA)
- Presentation - Launch of call for expression of interest for stakeholder co-chair - M. Carr (EMA)
- Presentation - Conclusions and next steps – forward planning of the meetings - O. Ademi (EMA)
Meeting dates
This document outlines the 2024-2026 meeting dates for the MSP Advisory group and the MSP annual meetings.
News
The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform (MSP) aimed at improving the environment for clinical trials across the European Union (EU).
The summary report has been published as an outcome of the first ACT EU MSP workshop held in June 2023.
MSP documents
This document outlines the MSP Advisory Group’s mandate and rules of procedures.
The summary report of the first ACT EU MSP workshop held in June 2023, to understand different stakeholder perspectives on how to transform the EU environment for clinical trials, discuss the feedback from the MSP public consultation and agree on a model for the establishment of the MSP.
The report on the outcome of a public consultation where the European Medicines Agency invited stakeholders to provide input on the ACT EU MSP concept paper, priority topics for the MSP and to express their interest in participating.
A concept paper is available on the importance of engaging stakeholders in all phases of a clinical trial, including trial design, and the objectives, composition, governance and transparency rules for the multi-stakeholder platform.
