This includes considerations such as study validity, safety, capacity, and site readiness. At the same time, a balance needs to be struck between restarting paused studies and allowing urgent COVID-19 care and research to continue, meaning that the framework also stresses the importance of prioritisation.
A key objective of the framework was to ensure that regulators, the HRA, the MHRA, patients, the public, and research organisations all worked together to support the restart and ensure coordinated UK-wide working, while restart decisions had to be made in partnership between local sites, sponsors, and Trusts – and according to Professor Stephen Smye, speciality cluster lead at the NIHR CRN, better collaboration will clearly be of vital importance in the future.
Joint working has been hailed by healthcare and life sciences leaders across the world as perhaps the most important element in the industry’s response to COVID.
But Smye says that the UK’s collaborative culture is second to none, and with NIHR people, facilities and systems representing the most integrated clinical research system in the world, the country is a unique place to deliver clinical research.
This has allowed UK researchers to answer questions of global importance about COVID-19 treatment and management quickly and efficiently.
“I can’t think of any other health system in the world that has managed to deliver the number of urgent public health studies the UK has – and through that the UK has achieved several breakthroughs of global significance, such as with dexamethasone, tocilizumab, and sarilumab,” Smye says.
“The pandemic has brought us together with partners in a way that allows us to work much faster than we would have imagined before. It has been quite transformational.
“Now we want to make sure that is baked into the system for the future.”
One example of how healthcare systems have implemented the Restart Framework comes from Nottingham University Hospitals NHS Trust.
Professor Steve Ryder, clinical director of research and innovation at the Trust, says that they began by setting up a Restart Group to explore which studies it was possible to reopen.
“This featured a quick review against local criteria, including whether the clinical service linked to the study was up and running, if participants could take part safely, and if the clinical team and sponsor were happy for the study to resume.”
Ryder says that involving patients and participants in the process was an essential step to building confidence. “We knew that some people were still anxious about returning to a hospital, so we created a survey to find out more about people’s attitudes and approaches that we could take to reassure them.
“The changes that we’ve made to research and our commitment to embracing new ways of working mean that we wouldn’t have to pause studies in the same way for similar events in the future.”
For an example of how Restart initiatives are changing UK research now, and in the future, we can zoom in on issues in patient recruitment.
Although lockdowns made recruitment difficult in the early days of the pandemic, this area has also seen a strong recovery.
As of the latest Restart update, 60% of previously paused studies have recruited participants, 268 new studies have opened to recruitment and 174 have recruited patients.
And things are looking bright for recruitment post-COVID – not least because there is now much greater public awareness (and a more positive perception) of clinical research in general. Visits to the NIHR’s Be Part of Research website, where the public can find out about clinical research and search for studies to participate in, have increased by 216% between February and December 2020.
“Initiatives like the Vaccine Research Registry have also shown the willingness of people to volunteer and the value that can bring, and that will have wider applicability going forward,” says Smye.
Smye adds that the NIHR’s “strong principle” of taking into account patient concerns in order to boost recruitment has been a key part of the Framework.
For example, the CRN’s Participant in Research Experience Survey asked over 11,500 individuals about their experience of taking part in research during the pandemic and found that safety in healthcare settings was a prime concern, with participants wanting clear information about how the sites they visit will be made COVID-safe.
“This information needs to be as specific as possible to the place they are visiting,” says Laurie Oliva, national head of public engagement at NIHR CRN. “For instance, we have heard a number of stories where participants have attended sites and have to use a different entrance than they did previously but had received no clear directions.”
People still value the same things in the research experience as they do at other times, such as regular updates, adds Oliva.
“We have found in past surveys that a good relationship with the research staff contributes massively to a positive overall experience, so anything that can sustain this engagement is important – and during the pandemic, a positive experience is still associated with regular, clear information from the research team.”
Meanwhile, although embracing digital technology and remote engagement has been a huge boon for trials and recruitment, Oliva warns that researchers also have a responsibility to ensure this technology works as well as possible for participants.
“As more studies use remote delivery, we are seeing many issues with participant use of apps. It is vital that platforms to engage participants in trials are designed to be accessible and that when participants struggle to use them, there is help available.
“We have heard many reports of people leaving a trial because they couldn’t use the digital tool required.”
The efficiencies and improvements gained from COVID-19 research and the Restart Framework are now being embedded into the UK system for future research.
“COVID has had a significant impact on patients with other conditions, the care and research on which they depend,” says Smye. “There is an enormous appetite to help patients and the entire research system learn from and recover from the pandemic.
“We’ve seen the success of the Urgent Public Health initiatives. We now know that this is a system that can and will deliver amazing things.”
Smye says the NIHR is continuing to work together with the whole research system – citing examples from the pandemic such as the MHRA’s Innovative Licensing and Access Pathway as emblematic of the collaborations and innovations the entire industry wants to see more of.
“That’s not to say the post-COVID system will look like the Urgent Public Health system, but there are certainly elements of that approach we want to bake into the new system.
“Meanwhile, initiatives that predate the pandemic, such as the NIHR Patient Recruitment Centres, will come to the fore working with the rest of the Clinical Research Network.
“We are working very closely with partners to make sure that vision becomes a reality.”
He adds that this again shows the pivotal importance of joint working to the UK ecosystem.
“The UK has a National Health System, but, uniquely, it also has a National Research System.
“That means that all parts of the system can be joined up, and what we’ve learned in COVID is that when we do join them up – as we did for the Urgent Public Health portfolio – we can deliver research in a globally-leading way.
“If we can embed that into the system for the future, we will see enormous advantages for the industry, the public sector sponsors and, crucially, patients.”
Professor Stephen Smye is a specialty cluster lead for the NIHR Clinical Research Network based at King’s College London. He is also professor in the School of Medicine at the University of Leeds. He was research and innovation director at the Leeds Teaching Hospitals from 2004- 2017 and has been involved with the National Institute for Health Research since 2007, in a number of senior leadership roles.
Laurie Oliva is national head of public engagement for the NIHR’s Clinical Research Network. Laurie oversees the Network’s Participant in Research Experience survey which aims to promote improvements in research design and delivery through routine collection of participant feedback, as well as the Network’s digital public services, Be Part of Research and Join Dementia Research. Laurie is product lead for the NHS Vaccine Research Registry, which aims to support rapid recruitment to vaccine trials by enabling potential volunteers to register their interest in taking part in studies.
The National Institute for Health Research (NIHR) is the nation’s largest funder of health and care research. The NIHR:
The NIHR was established in 2006 to improve the health and wealth of the nation through research and is funded by the Department of Health and Social Care. In addition to its national role, the NIHR supports applied health research for the direct and primary benefit of people in low- and middle-income countries, using UK aid from the UK government.
George Underwood is the editor for pharmaphorum’s Deep Dive digital magazine. He has been reporting on the pharma industry for seven years and has worked at a number of leading publications in the UK.