One year ago, a UK-wide vision for the country’s future research landscape promised streamlined processes, and a patient-centred, competitive environment. But how far have we come in achieving those aims? And what’s next on the system’s agenda?
From Brexit and COVID-19 to the wholescale shift in the way research is designed, conducted, and reported, the UK’s clinical trials sector has faced a raft of challenges in recent years.
With this in mind, all four nations signed up to Saving and improving lives: The future of UK clinical research delivery last year, setting out ambitious plans to create a “patient-centred, pro-innovation and digitally-enabled research environment”.
Twelve months on, we sat in on the Association of the British Pharmaceutical Industry’s (ABPI) update meeting to find out what has been achieved so far – and what more industry can expect.
Joined up thinking
Implementation of the first phase of the 10-year, UK-wide vision, which aims to “unlock the true potential of research” by putting “patients and NHS at its heart”, is underpinned by the Clinical Research Recovery, Resilience and Growth (RRG) programme.
Emma Lowe, Head of Research Policy for Clinical Research and Growth at the Department of Health and Social Care and RRG programme lead, said the plan, which launched in late 2020, was about using learnings of the pandemic as a “catalyst for change”.
“It’s not within any one single organisation’s gift to fix the problems we have. But by taking a unified approach across government, industry, charities, and the NHS, by all of us pulling in the same direction, we can create some fantastic change,” she said.
Cross-silo collaboration proved invaluable during the COVID-19 pandemic, but the period also heavily impacted other areas of research.
“The past two years have not been the easiest. We have had lots of challenges, particularly in the non-COVID space,” said Jennifer Harris, Director of Research Policy at the ABPI.
“We are not out of the woods yet, but we need to continue working together if we’re going to succeed in recovering the UK clinical research ecosystem, as well as growing our portfolio in the future.”
Creating a future-proof, globally competitive setting for research, the speakers said, relied on supporting the NHS to take part, streamlining processes, and strengthening patient and public involvement.
The biggest challenge to getting the UK’s research portfolio back on track after COVID-19 has been NHS capacity, Lowe explained. The UK’s Clinical Research Networks, she said, have been working in close partnership with trusts, R&D departments, and industry on a Managed Recovery Process, but progress has not always been easy.
“It has had a degree of success, but it’s not cleared the path for other (non-COVID) studies to return to the level of recruitment we would usually expect,” she said, adding that while average monthly recruitment activity is now higher than before the pandemic, a large backlog of studies on portfolio exists.
A plan to address this is currently with government health ministers for sign off, and is expected to be announced in the coming weeks, she said.
In the meantime, it’s important that sponsors do all they can to reduce burden on sites, said Health Research Authority (HRA) Director of Approvals Dr Janet Messer.
Using technical assurances, such as radiation or pharmacy assurances, or new model agreements, on confidentiality disclosure and non-interventional studies, for example, can expediate and smooth study setup from both ends.
“We need to make it as easy as possible for sites to take part,” said Dr Messer, pointing to the high demand the health service is currently facing as it continues to recover from the pandemic.
Streamlining regulatory processes is a central plank of the UK research vision. The prime example of this is the Combined Review service, which, as of January, has provided sponsors with a single point of application for Clinical Trial Authorisation and Research Ethics Committee (REC) opinion.
“We still have the relevant experts and committees doing their own reviews, but we have joined them up,” said Dr Messer. “It reduces problems we have had historically, where applicants have felt torn between one regulator asking one thing, and seemingly another regulator asking for something slightly different.”
This new approach also offers the option of a fast-track REC opinion, she went on, adding that this gave the UK a competitive edge as a research destination.
Strengthening patient involvement
High on the UK’s vision’s wish list was a stronger focus on patient and public involvement in research – and the last two years have shown just how much work there is to do in this area.
“We know that involving the public can help researchers do better studies, but public involvement was not resilient to the pandemic,” said Becky Purvis, Deputy Director of Policy and Partnerships at the HRA.
“Only 20% of COVID-19 research applications involved patients or the public in March 2020, a fall of around 80% when compared to normal times.”
The authority’s UK COVID-19 Public Involvement Matching Service, which helped researchers access patients for SARS-CoV-2 studies, was very successful. Yet the fact that it was needed demonstrated the element was still viewed as a “nice to have” in many quarters, said Purvis.
“We are now setting out to develop a UK-wide, all-sector commitment to public involvement in research, aiming to show that the meaningful involvement is important, expected and possible,” she said.
“We’re working with National Institute of Health Research (NIHR) to bring together regulators, sponsors, and funders to affirm and amplify the importance of public involvement throughout the research cycle.” Project outputs will include actions, guidance, and clear statements of intent.
Future research environment
We are just one year into the 10-year vision, which aims to make England, Ireland, Scotland, and Wales an attractive proposition for international sponsors.
While there’s still a lot of work to be done, one thing is clear from everything that has been achieved so far – partnership is key. Regulators, charities, industry players, academia, and the public all have a role to play in future-proofing the UK’s place at the cutting edge of clinical research.
About the author
Amanda Barrell is a freelance health and medical education journalist, editor and copywriter. She has worked on projects for pharma, charities and agencies, and has written extensively for patients, HCPs and the public
This post was originally published on Source Link