EMA wants participants to serve on clinical trial multistakeholder forum

Regulatory NewsRegulatory News | 03 February 2023 |  By 

The European Medicines Evaluation Agency (EMA), the Heads of Medicines Agencies (HMA), and the European Commission are calling for representatives from the research community, pharmaceutical sponsors, academics and regulators to participate in a new multistakeholder platform (MSP) or forum to share and implement ideas for improving clinical trials in the EU.
The call for participation is being launched under last year’s EC-HMA-EMA initiative Accelerating Clinical Trials initiative (ACT EU), to transform how clinical trials are initiated and run and to promote clinical research in the region. The initiative is also meant to address a “relative absence of EU impactful multi-state trials” prompted by the COVID-19 pandemic (RELATED: EU launches clinical trials transformation initiative, Regulatory Focus, 18 January 2022).
“For the clinical trial environment to evolve with advances in regulation, methodologies, technology and science, there is a need for multi-stakeholder discussions to drive and support change,” said an EU announcement.
Regulators released a concept paper which discussed the framework of the MSP, including its scope and objectives, MSP composition, organizational aspects, governance structure and meeting frequency.
The forum will explore all aspects of clinical trials; including trial design, conduct, statistical analysis; as well as address whether regulations should be revised. It will also address data transparency and patient engagement.
The composition of the MSP will be depend on the feedback received, yet regulators would like the forum to consist of representatives from patient organizations, healthcare professionals, academics, users of clinical trial data, clinical trial investigators, clinical research organizations (CROs), sponsors, and inspectorates.
Once established, the MSP will meet with the ACT EU Steering Group every quarter through a virtual or hybrid format. The MSP will conduct its work through plenary meetings and ad hoc topic groups; this work will be supported by an established secretariat. The MSP secretariat will also liaise with ACT EU Steering Group and MSP, and set the meeting agendas, draft a workplan, manage MSP composition, and disseminate meeting minutes.
The concept paper calls for a kick-off meeting to be held during the second quarter of 2023, and for a stakeholder consultation on MSP governance during the first quarter and second quarter of 2023.
During the latter part of 2023 and 2024, the MSP will work on topics deemed a priority by its members and finalize its operating model. From 2025 and onwards, the MSP will transition to a “more sustainable resourcing model.”
According to the concept paper, plenary meetings will be held two to four times a year while ad hoc meetings will be held on an as needed basis.
The deadline for responding is 3 March 2022.
Public consultation announcement
Concept paper


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Tags: ACT, clinical, EMA, EU, trials

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