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Impact of Brexit on Quality Assurance and Innovation in Clinical Research

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Supporting Inclusion in UK Research

One of the most popular arguments for a “remain” vote amongst the scientific community was the damage that EU funding cuts might do to innovative late-stage biomedical research. Phase 1 trials make up a large share of UK projects, but moving these to clinical research that advances drug discovery in key target populations is a slow process.

However, funding is not much of a problem. The UK could replicate the level of funding of EU programs internally. The bigger issue is collaboration and inclusion—or lack thereof—of UK science. The country is missing out on a sizeable piece of the European research pie: opportunities like Horizon Europe and the capacity to lead them as freely as before.

The uncertainty around investment in flagship life sciences projects, and short-term measures to ensure the UK remains a scientific powerhouse, has shifted decisions about inclusion since the vote—negatively affecting the dynamic environment needed for drug development.

Fast forward to today, and Prime Minister Boris Johnson has renewed his commitment to fuelling UK life sciences innovation. He told global investors at the 2022 JPM Healthcare Conference during his keynote address to “choose the UK as the place to discover, innovate and find the solutions for the future in partnering for precision medicine and population health studies”—two research priorities for strengthening drug development.

brexit-series-impact-of-vote-on-uk-research-quality-assurance-and-innovation

New Research Vision

The UK’s new research direction will involve much cross-disciplinary research mobilising the national expertise, especially in T-cell research, artificial intelligence (AI) technology, antivirals and genomics (RNAi).

Johnson’s government committed to reaching overall research spend of 2.4% of UK GDP by 2027. Spending on science is set to increase, and further alliances are made to deliver solutions for the world. However, the UK is yet to get close to the spending of hubs across the Atlantic.

In 2015, the Bioindustry Association (BIA) outlined a 10-year strategy to rival Massachusetts and the San Francisco Bay Area biotech hubs, which raised more than all of Europe in the first quarter of 2019 or eight times as much as the UK.

Data from the Association of the British Pharmaceutical Industry (ABPI) on the numbers of patients enrolled across all clinical research phases in each country shows that the UK is fifth in the list of countries with the most phase 3 trials in 2017, behind Germany and Spain.

More liberal development of phase 3 trials is desperately needed to advance innovation in rare diseases like Duchenne muscular dystrophy, which is at risk from non-inclusion into European research initiatives. These diseases require cross-border collaboration because of their very nature: there are only small patient numbers in each country.

A bill to create a new research agency and expand the UK’s research portfolio was introduced to Parliament in December 2021. The Advanced Research & Invention Agency (ARIA) will complement the work of UK Research and Innovation (UKRI) in supporting high-risk, high-reward science.

The new independent research body is backed by £800 million and inspired by the influential US Advanced Research Projects Agency (ARPA) model. ARPA’s successor, DARPA, was a pre-pandemic funder of mRNA vaccines and antibody therapies.

ARIA will deliver funding to the UK’s most pioneering researchers through program grants, seed grants and prize incentives. It is said to have a “higher tolerance for failure than is normal, recognising that in research the freedom to fail is often also the freedom to succeed.”

DARPA's new headquarters in Ballston, VA.

DARPA's new headquarters in Ballston, VA.

New Trials Legislation

UK clinical trials rely heavily on the EU Clinical Trials Directive; an EU regulation considered a beacon of safety standards. The UK has domestic laws, but it doesn’t have an entire codification of health research on drugs like the EU does.

Under the EU Withdrawal Agreement Bill, existing provisions of the EU law are carried over and still apply. “While it is not inconceivable the UK will have its own human research act, we won’t be ‘scrapping’ the trials directive,” Carl Heneghan, a professor of evidence-based medicine at the University of Oxford, wrote in The British Medical Journal (BMJ).

“Largely, because the directive follows Good Clinical Practice (GCP), something many countries endorse, to protect patients and volunteers and define the different roles for those involved in trials.”

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The UK research suppliers and major players still need to consider how they will be aligned as a state with further international GCP standards over the medium term. The EU withdrawal did not lead to regulatory consistency regarding how entry into trials is regulated, for example.

ABPI called for the UK’s regulatory and research environment to remain aligned to the EU, as too much divergence can render the inclusion of the UK in multi-country clinical trials more complex for sponsors.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is considering adopting measures to speed up low-risk trials, lighten the bureaucracy load at the front end of trials, and add some legislation to the back end of trials, following the EU’s lead.

As of 31 January 2022, ongoing and upcoming EU trials with UK buy-in benefit from a new reform: The Clinical Trials Regulation (CTR), which modernises the current framework for clinical trials and ensures a greater level of harmonisation.

brexit-series-impact-of-vote-on-uk-research-quality-assurance-and-innovation

The new regulation also provides, amongst other things, a new information system and access to an associated EU-wide database. It is intended to reduce administrative burdens on applicants and simplify the process for companies wishing to conduct multi-centre clinical trials in the EU and the UK, with different authorisation procedures.

Previously, UK clinical trials could not go ahead without the Research Ethics Committee (REC) and MHRA approval. Under the MHRA’s ‘risk-based regulation’ proposals, trial sponsors can initiate “low-intervention trials” without extensive regulatory review.

Low-intervention trials are defined as trials where the risk is like that of standard medical care and includes trials of medicines approved for human use elsewhere in the world where the trials seek to explore indications, dosage and form, or their ‘off-label’ use. The requirement for an ethics review would, however, be retained.

The MHRA also set out plans to boost patient engagement in clinical trials. Patient-centricity is at the core of the pandemic-born decentralised and hybrid trial design norm. Contract research organisations (CROs) have developed better patient communications portals.

The idea is to work in partnership with people and communities to design trials that fit into patients’ lives more seamlessly and to capture important trial information while reducing the burden on patients and investigators alike.

Ensuring all trial data, whether commercial or academic, are made available for public consumption is another goal that MHRA is working towards. This and the full set of MHRA proposals were open to consultation until 14 March 2022 and inform final policy decisions for a more efficient and effective research environment.

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Access to Clinical Talent

Every year, the UK's 'para-Ivy League' of ancient universities like Oxford or Cambridge attracts many top scientists from elsewhere in Europe with the help of EU grants. Brexit threatened to jeopardize their status at the forefront of science and the wide nets that pharmaceutical sponsors and the rest of the UK drug development sector could cast.

It was essential during UK's transition arrangements to maintain a welcoming environment for scientific and clinical talent from around the world. The rights of EU and European Economic Area (EEA) citizens and those of Swiss nationals in the UK, who are heavily represented in areas like R&D, have been protected.

EU citizens who had moved to the UK by 31 December 2020 could apply to the EU Settlement Scheme until 30 June 2021, granting them either a pre-settled status or indefinite leave to remain—if they had lived in the UK for five years or more. And EU students and researchers involved in EU research programmes can stay.

Further options are available to help top talent pursue their research ambitions in the UK. For example, those holding a PhD in science, technology, engineering, and mathematics (STEM) can apply for a visa through the skilled worker's route, with a job offer from an approved sponsor. The government also created an alternative, unsponsored way for 'leaders' in academia, open to EU citizens.

Taken together, the end of the Brexit transition period affords the UK a once-in-a-generation opportunity to review and update its legislation for clinical trials. A chance to reposition it as the go-to place to develop innovative healthcare products whilst always protecting patients and trial participants.

This article is accurate and true to the best of the author’s knowledge. Content is for informational or entertainment purposes only and does not substitute for personal counsel or professional advice in business, financial, legal, or technical matters.

© 2022 Camille Bienvenu

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