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Grading the government’s formal response to reform efforts hopeful of boosting UK’s sagging global standing in drug development.
It is no surprise that the UK government recognizes the merits of clinical trials. Part of the country's prosperity has been built on the research and development of new medicines. But the uncomfortable recognition has now dawned at official level, too, of the long-predicted errors of Brexit, which has split the country off from the research, trade, and regulatory solidarity that flowed from its half-a-century of European cooperation. For clinical trials as for so many other areas of British activity, Brexit is having serious consequences. As the government acknowledges in its recent evaluation1, the country's status is taking a hit, and it is now clear that "the UK’s position in the global clinical trial landscape has shifted, as other countries recover their delivery performance post-pandemic, providing attractive alternatives in what is a highly competitive field."
However, the harsh reality is still a truth that dare not speak its name, and the refusal to admit the role of Brexit in these deteriorated circumstances is driving contortions of language and logic to find alternative culprits, and to paint any losses as a good thing. The current problems derive from "delivery performance post-pandemic," and "our departure from the European Union provides an unparalleled opportunity to build on this foundation to advance how clinical trials are regulated across the UK." Resigned (certainly for the foreseeable future) to going it alone, the UK is promising, in this latest document, to "take forward new legislation to update, improve, and strengthen the UK clinical trials legislation"—to "capitalize on the opportunity." So, in turn, will "deliver a world-class sovereign regulatory environment for clinical trials." And to ensure no crack in the rhetoric might allow for any doubt, it will make the UK "world-leading in efficient and cutting-edge clinical research."
So, what is in the government's mind for seizing this questionable stroke of luck of the UK's weakened international competitiveness and its reduced attractiveness for trials? The goal is "a stable and streamlined framework" and "a robust, progressive baseline from which the UK can develop innovative regulatory approaches to rapidly emerging science and technologies." Just in case that wasn't enough, "these reforms are just the beginning of the UK’s journey to becoming a transformational, global regulatory leader."
The mechanisms that will effect this transformation include "streamlining regulatory approval and the assessment of trial applications" using "risk-appropriate approaches," "providing a more flexible and enabling regulatory regime to support greater innovations in clinical trials and be more adaptable to different types of trials" with "internationally competitive approval timelines " They will include "the use of real-world evidence, novel analytics, and data tools."
The perennial questions arise of introducing reform while ensuring safety amid: "Patient safety is of paramount importance and trials must be conducted to the appropriate standards to assure the safety of those who participate in trials," the plans note. Reassuringly, but unremarkably, "the measures proposed to streamline application processes are intended to facilitate good, safe research while ensuring appropriate regulatory scrutiny of trials."
All very meritorious, but all rather obvious—and very much the sort of mechanisms that are already being employed or planned in many of the geographies that the UK admits it is in competition with. Indeed, some of them mirror almost word for word those already in force in the EU through its 2016 clinical trials regulation, such as the requirements to register a trial, to publish a summary of results within 12 months of the end of the trial, and to share trial findings with participants in a suitable format.
In fact, the government does briefly acknowledge stakeholders' concerns over alignment with the EU. "A key aspect that responders (to a consultation) highlighted needed further consideration was ensuring alignment with the EU clinical trials process (and also the US in some cases), with many responders expressing that they would like as close an alignment to EU legislation as possible, so that duplication of work is minimized."
Its answer to these concerns is careful, and carefully avoids any mention of the EU. "We have heard the concerns around ensuring alignment with other international processes, and those concerns are addressed," it says. "We are clear that international standards for clinical trials will be maintained, and while legislative changes may streamline how clinical trials are approved in the UK, the core documentation and evidence to support a clinical trial application will remain aligned with international expectations."
Hence, the plans also explicitly include "working in partnership with likeminded regulators globally, in "collaborations such as the FDA’s Project Orbis and the Access Consortium (Australia, Canada, Singapore and Switzerland)" and "in global standard setting forums such as the International Council for Harmonization of Technical Requirements for Pharmaceuticals of Human Use"—but not with the EU.