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EMA opens public discussion on envisioned platform to encourage multi-stakeholder interactions and shared understanding.
The ambitions of many for a greater degree of collaboration in clinical trials in European regulation look as if they are to be fulfilled—at least in part. The European Medicines Agency has just opened a public consultation on setting up a multi-stakeholder platform "to improve the clinical trials landscape" in the European Union.
Formally recognizing what has been obvious for years—that "successful clinical trials require the collaboration of a wide range of stakeholders"—the consultation document sees the envisioned creation of this platform as a way of encouraging interactions at EU level and promoting shared understanding. The announcement stresses the importance of "a neutral forum for balanced discussions," and of "building trust through a better understanding of the perspectives and roles of different stakeholders."
The list of the "different stakeholders" is becoming a familiar pattern in international consultations of this sort—as seen in the World Health Organization (WHO) call discussed in this column in January—and ranges from patients, healthcare professionals (HCPs), academics, and investigators, to contract research organizations (CROs), sponsors, ethics committees, research funders, regulators, and payers.
The declared aim is to drive the evolution of clinical trial methods and approaches, identify areas for progress, and find practical solutions for the clinical trial environment to evolve in regulation, methodologies, technology, and science. It wants to embrace how innovation may come through the use of shifts toward emerging methods, including novel trial designs, endpoints, techniques for gathering data, use of “omics” to stratify populations, or real-world data to generate comparator groups or follow-up. Its scope will include statistical analysis, revision of regulation, transparency of data, and patient engagement. It will also serve as a place to discuss and address challenges linked to the implementation of new legislation, guidance, and methodologies.
The spur for this initiative—as for many other recent regulatory developments in Europe—has been the experience with the COVID-19 pandemic, and its demonstration of how patient access to treatments can be accelerated by innovation in the way that clinical trials are designed, regulated, and conducted. Needless to say, the platform will also involve representatives of the European Commission, the EMA management board, the EU's clinical trials coordination group, EMA's committee for medicinal products for human use, the network portfolio advisory group, and heads of medicines agencies
The platform is expected to start work in the second quarter of this year, and will meet regularly to set priorities that will be followed up by technical topic groups. A first workshop in the spring will present the detailed proposal and agree on a preliminary workplan. Across 2023-2024, it will work on the priority topics initially identified, and finalize its operating model, with full implementation anticipated from 2025 onward backed by a "sustainable resourcing model."
Underlying it all is a broader policy goal of developing the EU as a focal point for clinical research and medicines development, as well as integrating clinical research more effectively in the European health system. It is "crucial to ensure that the perspective of all stakeholders is included in the platform," says EMA, and anyone wishing to offer their views on how this it should function—or even to volunteer to participate—is invited to comment until March 3.1