In a report published by the European Medicines Agency in July 2023 the lessons from the COVID-19 and mpox PHEICs are explored, considering the need to improve clinical trial (CT) processes during “crisis times”. This was the result of a workshop organised by the EMA’s Emergency Task Force and the European Commission. The report aims to “holistically address” the “barriers and challenges” from the pandemic and mpox outbreaks in setting up “adequately sized clinical trials’ across Member States to enable swift and sufficient gathering of evidence to inform “robust decision-making” across the EU.
Challenges and barriers
The report states that the COVID-19 pandemic illustrated “structural challenges” and barriers that hamper the set up and start of large, multinational CTs.
“The fragmented clinical research landscape across the EU/EEA and competition for the same resources and patient populations was detrimental to early patient access and rapid generation of conclusive evidence on safety and efficacy of promising vaccines and treatments.”
It suggests that coordinated studies were impaired by the difficulty of “activating networks of clinical trial sites” and ensuring “timely funding”. Furthermore, the time taken to secure authorisation to begin CTs was “slow and burdensome”, a concern highlighted by a recent report from MPs in the UK.
Key focus
The report sets out actions within two key areas:
- The processing and regulatory approval of large, multinational clinical trials in the EU during public health emergencies.
- The framework for funding and efficient allocation of resources for clinical trials during emergencies in the EU.
EMA’s Emergency Task Force’s role is expanded through the recommendations to include concerned ethics committees alongside the provision of scientific advice, reviews, and support. The focus was on making Europe a “better place for research”.
After hearing the concerns of MPs about the clinical trial environment within the UK, it is interesting to see Europe accelerating out of these public health emergencies with vigour; can the UK keep up? Don’t forget to subscribe for more like this.
