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The Accelerating Clinical Trials in the EU initiative formally kicks off, with many stakeholders weighing in on what should be the top priorities and goals.
Despite 20 years of progressive alignment of clinical trials regulation in Europe, the continuing split in responsibilities across multiple jurisdictions and practices means that not many impactful multi-state trials take place there. The result is that the EU is seen as less friendly for clinical research, according to Monique Al of the Heads of Medicines Agencies (HMA) in Europe, introducing a workshop in late June on how the problems might be fixed.
Among the various official responses to the deficiencies in the European environment, the recent Accelerating Clinical Trials in the EU (ACT EU) initiative is now starting to take shape. ACT EU is the product of the European Medicines Agency (EMA) and the HMA, along with the European Commission. They describe it as “a business change initiative to transform the EU clinical research environment” with top-quality scientific advice and optimized regulatory oversight conducive to conducting large trials that deliver decisional evidence. The declared aim is to use new tools and methods such as decentralized and complex trials—on both of which guidance was published during 2022—combined with digitization and future-proof guidance. It builds on the Clinical Trials Regulation (CTR) and the related Clinical Trials Information System (CTIS), on the EMA/HMA Network Strategy to 2025, and the EU’s pharmaceutical strategy—now being given more concrete form in the ongoing revision of the rules on marketing autorization.
For 2023, the main objectives of ACT EU are to ensure effective implementation of CTR and CTIS, to launch a support scheme for academic sponsors conducting large multinational clinical trials, and the creation of a multistakeholder platform to promote collaboration for better clinical trials. The concept of this platform—a longstanding request from patients, professionals, and product developers (although each for their own reasons)—is to promote regular dialogue among everyone involved in designing, regulating, performing, and participating in trials so as to advance identification of scientific, methodological, and technological advances that will develop the European clinical trials environment. In theory at least, it will incorporate the views, needs, and concerns of all parties involved in the process—and “engage all stakeholders to proactively deliver inclusive patient-oriented medicines development and delivery across populations.”
The kick-off meeting for this ambitious venture took place at the end of June, and indicated the broad range of priorities from the different stakeholders attending. Patient organizations said they wanted to be part of “a continuous feedback loop by partnering with regulatory bodies and clinical trial sponsors” and for greater access to data, while also ensuring greater prominence for patient-reported outcome (PRO) measurements in the processes. For the research-based drug industry, the key issue is the need to ensure greater alignment between the rules on clinical trials and on medical devices and in vitro diagnostics. Medical societies wanted to see more streamlined regulation and reductions in “excessive” safety reporting. University researchers shared the desire for simplified regulation so as to ease the burden on participants and trial staff and promoteefficient resourceutilization. The focus of contract research organizations (CROs) is greaterreal harmonization and consistency for submission requirements. Ethics committees, defiantly proud of their record and role, urged the creation of an EU ethics forum with representatives from each member state, and suggested that the provision of scientific advice by regulators may need ethics committee participation and even ethical assessment. And regulatory authorities in the EU member states are concentrating on promoting collaboration among ethicscommitteesin pursuit of singledecisions.
In short, as even this brief summary reveals, it’s a wide variety of asks from a wide variety of perspectives. It was perhaps the issue of transparency of data, however, that prompted the most intense discussions. The dilemma was posed by a group of Spanish investigators, who said the ACT EU platform should promote transparency “and at the same time” advocate the protection of sponsors’ rights. But the European Public Health Alliance is less ambiguous: it wants enhanced transparency with the maximum of information being made available and in full and on an ongoing basis “for greater accountability and compliance.” CROs, on the other hand, felt that “information in some documents may not add value to research community or participants,” and there should be more “focus” by “reducing lists of publishable documentation.”
That is going to be a challenge that all the skills and goodwill of platform participants will be needed to meet.
Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium