The Medicines and Healthcare products Regulatory Agency (MHRA) has announced proposals to "streamline" clinical trial approvals, in what it called "the biggest overhaul of trial regulation in 20 years"
This followed the news reported last week that the Agency had been awarded an extra £10 million in additional funding over the next 2 years, specifically to fast-track drug approvals.
The forthcoming legislative changes required to expedite trials would help to make the UK "one of the best countries in the world [in which] to conduct clinical research", the MHRA said. The trials approval process will in future adopt a "more proportionate, streamlined and flexible" framework without, of course, compromising on safety. It will help to cement the UK as an attractive destination for trials, including global 'multi-site' trials.
For example, in a pilot phase it was found that integrating the regulatory and ethics reviews of clinical trial applications halved the approval times for studies and cut the time from application to recruiting a first patient by 40 days, and this will be "embedded" into the new regulation. The MHRA will also implement a timeline for completion of an application review within a maximum 30 days in general, with a maximum 10 calendar days for a decision to be granted once the regulator has received any final information.
In addition, to enable "transparency", the new framework will introduce a legal mandate to register the trial in a World Health Organisation (WHO) public register, along with a requirement to publish a summary of results within 12 months of the end of the trial. "Sharing trial findings with participants in a timely manner and suitable format will also be required by law," the MHRA said.
New Regulatory Framework to be as Future-proof as Possible
These changes follow a public consultation in partnership with the Health Research Authority (HRA) and the Department of Health in Northern Ireland. They "will result in a regulatory framework that is as future-proof as possible, responsive to different types of trials and innovative designs, and supportive of new ways of carrying out trials such as decentralised trials", the MHRA avouched.
The Agency said that it will produce "comprehensive new guidance", co-designed with stakeholder groups, to accompany the new legislative measures, including outlining how patients can be "meaningfully" included in the design and conduct of trials, and "how to achieve diversity in trials in a way that is proportionate and achieves the best results".
The end result "will ensure that UK clinical trials truly work in partnership with patients and the public, and are representative of the diversity of people who may benefit from the medicine if the data generated ultimately lead to regulatory approval", the Agency said.
Accelerating Routes to Market for Innovative Products
Last week's funding announcement, said the Government, would aim "to accelerate routes for bringing innovative medical products developed in the UK onto the market, as well as those made and approved by other trusted regulatory partners globally". This would be achieved through "a thorough but shortened process to speed up the approval process for cutting-edge treatments developed in the UK with the greatest opportunity to meet the UK's healthcare priorities".
The additional funding would also support an international recognition framework, allowing the MHRA to capitalise on the decisions of "trusted regulatory partners" such as the FDA in the US and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.
Announcing the funding last week, Steve Barclay, Secretary of State for Health and Social Care, said: "Technology is transforming our care for patients, delivering faster and more accurate diagnoses. This new funding will accelerate the delivery of cutting-edge treatments like cancer vaccines and new artificial intelligence technology that will make therapy more accessible to those who suffer from mental health conditions."
In support of the latest announcement, Mr Barclay said: "The UK continues to lead the way in ground-breaking clinical trials and these reforms – the biggest in 20 years – will make this country an even more attractive place for scientists and researchers to work.
"These changes will help speed up clinical trials, without compromising on safety, and encourage the development of new and better medicines for patients. They come after the government announced additional funding of £10 million for the MHRA to accelerate the delivery of cutting-edge treatments including cancer vaccines."
Changes to be Implemented 'as Quickly as Possible'
MHRA's Chief Science and Innovation Officer, Marc Bailey, stressed the importance of ensuring that regulation was "flexible and agile", and said the new legislation would do just that: "It will move us away from a one-size-fits-all approach to the regulation of clinical trials, and help to streamline approvals by removing granular and duplicative regulatory requirements.
"This will make the UK one of the best countries in the world to conduct clinical research and, get innovative medicines to the people who need them faster." He promised that the changes would be implemented "as quickly as possible".
Welcoming the commitment to "co-develop" new regulatory guidance along with industry, and the MHRA's "pragmatic approach to patient and public involvement", Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: "It's great to see the MHRA taking forward these important changes to UK clinical trials regulation centred on patient safety and the benefits of participating in research. "The reforms are a significant step forward for UK clinical trials and come at a crucial time for industry clinical research in the UK."
