The EMA has also announced a plan to expedite study set-up on the back of the Clinical Trials Regulation, coming into force at the end of this month. But beneath the rhetoric of Brexit deregulation, the UK does not want to diverge from international peers
The UK has opened the final consultation on its plans to revise the rules regulating clinical trials, the country’s latest post-Brexit act of scientific deregulation that has seen it take a more laissez-faire attitude in other areas like gene editing and artificial intelligence.
Creating a “world-class sovereign regulatory environment for clinical trials”, includes plans to scrap duplicate reporting requirements when patients have adverse reactions to experimental drugs and to set a guideline maximum timeframe of 30 days to get approval for a new study.
To “reflect that we have left the EU”, the UK wants “more proportionate regulatory requirements” in order to gain a “competitive advantage, encouraging sponsors to run trials in the UK,” according to the final consultation document published by the Medicines and Healthcare products Regulatory Agency, on 17 January.
During the pandemic, the UK was particularly fleet-footed, rapidly setting up national trials of COVID-19 drugs and vaccines. The Recovery trial, which has to date recruited 46,491 patients at 190 hospitals across the country, provided evidence within months of the outbreak that the low-cost steroid, dexamethasone, cut the risk of death by up to a third.
Recovery has also been important in showing some treatments and drugs are not effective, with the most notable example being the demonstration that despite all the hype, there was no clinical benefit from the malaria drug hydroxychloroquine.
How COVID-19 hit clinical research
Initially, the pandemic led to many non-COVID-19 studies being suspended and the number of people recruited to trials across Europe fell sharply, according to a recent report by the Association of the British Pharmaceutical Industry.
The UK took the biggest hit, with enrolment falling by 82% in May 2020, compared to May 2019. In France, Germany and Spain enrolment was down between 66 - 70% in May 2020 compared to a year earlier. In Italy, the first country in Europe to be hit by the pandemic, enrolment in April 2020 was 60% lower than in April 2019.
But the ABPI report shows that mainland Europe bounced back. Italy and Spain recovered fastest, with enrolment in June 2021 37% and 34% higher respectively, than in June 2019. In the UK enrolment in June 2021 was still 15% below June 2019.
“The UK continues to lag behind international comparators in recovering enrolment in commercial studies,” the ABPI said when the report was published in September 2021.
The overhaul of clinical trials regulation in the UK will replace the existing legislation, which is based on EU rules. The consultation proposes “removing obstacles to innovation”, for example allowing trial sponsors to submit a single application that covers both ethics and regulatory review.
In another move to reduce red tape, it is proposed that trial investigators will no longer have to submit duplicate reports to MHRA and ethics committees when patients suffer serious adverse reactions to drugs. Rather a single report will go to MHRA, which will decide if the ethics committee should be involved. If the MHRA has to step in, it will be able to halt just one arm of a trial, not the whole thing.
Zoe Martin, a policy manager at the research charity Cancer Research UK, said she is “broadly positive” about the changes. “There’s nothing that’s caused alarm bells,” she said.
As a result of Brexit, the UK no longer has access to the EU’s central database of clinical trials, meaning the set up a cross-border trial with the EU requires complying with two sets of regulations, said Martin. Now, she hopes that the UK does not diverge too far from Brussels.
Despite the UK’s rhetoric about Brexit allowing it cut trial red tape, many of the changes it proposes reflect similar shifts underway in the EU, observers say.
“A lot of these reforms are based on EU reforms that the UK fed into” when as an EU member it played a large part in framing the Clinical Trials Regulation, said Martin.
The long awaited Clinical Trials Regulation coming into force at the end of this month, aims to cut down on paperwork and weed out duplicate trials between member states. It replaces the much-criticised 2004 Clinical Trials Directive, which is widely viewed as making it hard to set up multi-site studies with a single protocol and powered to deliver the data needed for regulatory decision-making.
On the back of the new regulation, the European Medicines Agency last week launched its own initiative to accelerate clinical studies, saying that the pandemic had exposed a “relative absence of EU impactful multi-state trials”, with a patchwork of national regulatory systems hindering pan-European projects.
With clinical trials becoming more complex, decentralised, and involving tools like machine learning, the system needs reform, said Silvia Garcia, a science policy expert at the European Federation of Pharmaceutical Industries and Associations. The introduction of the regulation at the end of January “starts the beginning of an exciting new phase for clinical research in Europe,” she said.
Under the new system, pan-EU trials only need a single set of documents, which during the first part of the clinical trial assessment would be judged jointly by all member states taking part, explained Garcia.
Bureaucracy will be cut in other areas too. More streamlined safety reporting will cut down on the need to submit identical reports to multiple authorities. Timelines by which national ethics committees have to respond will be harmonised.
The UK’s proposed overhaul, and the EU’s new regulation, both mandate that results must be made public within 12 months, said Till Bruckner, a UK-based campaigner for trial openness.
“The only divergence in this area is that while the EU only requires the results of drug trials to be made public, the UK will extend this requirement to cover all clinical trials,” he said.
This would make the UK the first country in the world to adopt openness standards recommended by the World Health Organisation, Bruckner said.
This article has been amended to better explain the impact of the Clinical Trials Regulation.