The European Medicines Agency (EMA) says a new platform will improve collaboration between regulators, sponsors and CROs working in the clinical trial space.
The regulator rolled out the “multi-stakeholder platform” (MSP) last month as part of the Accelerating Clinical Trials in the EU (ACT EU) initiative – a joint effort with the Heads of Medicines Agencies (HMA) and the EC aiming to transform how studies are initiated, designed, and run.
At the launch meeting María Jesús Lamas, director of the Spanish agency of medicines and medical products, who is regulatory co-chair of the group, predicted the platform would make drug research more straightforward.
“The establishment of the multi-stakeholder platform is an important milestone for ACT EU. Our collaborative efforts will drive progress towards more streamlined and efficient clinical trials and allow patients and citizens to benefit from clinical research in Europe,” Lamas said.
The idea is to foster collaboration and promote open dialogue around the challenges and opportunities represented by advances in clinical trials regulation, methodologies, and technology for the benefit of EU citizens.
The EMA added that organisations which engage with the platform will be encouraged to discuss clinical trial design, conduct, statistical analysis, proposals for regulation optimization, transparency of data, and patient engagement.
Integration
The ACT EU initiative was launched in January 2022 to further develop the EU as a focal point for clinical research, to promote the development of high-quality, safe and effective medicines, and to better integrate clinical research in the European health system.
Initiative members have identified 11 “priority action” areas ranging from the modernization of good clinical practice guidelines, analytics, trial methodologies and patient safety.
In January last year the ACT EU team published recommendations on the use of remote and decentralized trial models to streamline the drug testing process – particularly in terms of patient recruitment.
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