In the spring of 2020, it became evident that the Covid-19 pandemic would have a double impact on the clinical research sector. For business organizations with the resources and flexibility to scale research rapidly, the pandemic has provided an opportunity to lead potentially lucrative new markets for vaccines, treatments, and diagnostic tests. But for other areas of disease, Covid-19 has been a major disruptive force, halting trials in their tracks and exacerbating existing weaknesses within the sector.
This dynamic of feast and starvation was perhaps most evident in clinical trials in the UK. The country’s clinical research sector has been praised for its rapid response to the pandemic, which led to the development of the Oxford / AstraZeneca vaccine and the establishment of the NHS RECOVERY platform trial, but it has also seen one of the largest reductions in non-Covid-19 testing activity.
When Covid-19 first struck in the second quarter of 2020, the UK launched 55% fewer commercial clinical trials than in the second quarter of 2019, according to analysis of data from GlobalData. And although business testing activity has since returned to pre-pandemic levels in Australia and the United States, the UK remains lagging behind, starting 18% fewer commercial trials in the first three. quarters of 2021 compared to the same period in 2019.
The slow resumption of trials prompted the British Pharmaceutical Industry Association (ABPI) to call for the “revitalization” of the clinical research sector. The clinical research-focused group’s recent annual report argues that the UK needs to apply lessons from the successes of its own Covid-19 research more widely and learn from other countries that have weathered the pandemic with greater ease.
ABPI’s research policy manager Dr Jennifer Harris said the pandemic has increased pressure on already fragile areas of the research process.
“The only thing we were talking about before the pandemic which was then amplified by Covid-19 was the resources and the ability of the NHS to conduct research,” Harris said. “Before the pandemic we constantly mentioned that research needed to be more deeply rooted in the NHS, we needed protected time for research, we needed research to be part of everyone’s daily work rather than a separate thing. ”
Harris says that since clinical research was not a central focus within the NHS, once the pandemic strained health services, non-Covid-19 research had “fallen by the wayside.”
“Because clinical research in interventional studies is conducted in secondary care facilities and must have access to the same clinical facilities as primary care, this means that if you have a full transfer of resources to Covid-19 and the ‘wiping out waiting lists then means it’s hard to get clinical research on people’s agendas,’ says Harris.
The UK had fallen in the global ranking of clinical trial activity before the pandemic. The country has traditionally been regarded as a world leader in cancer research and in the first half of the decade one in seven oncology trials included participation in the UK. But by 2019, that number had fallen to just one in 12.
The UK has also seen a sharp drop in pre-Covid-19 phase I trials, with the share of commercial trials at this stage dropping from 8.4% in 2016 to 3.6% in 2019. In both cases, the Dramatic growth in testing activity in China explains some of the reduced share, but the country also compares unfavorably to other high-income economies. Australia and Spain, for example, have doubled their rate of new Phase I commercial trials since 2010, while the UK launched the same number of new trials in 2020 as a decade earlier.
Some countries have benefited from a lower prevalence of Covid-19 – Australia, for example, did not see the closure of test sites during the early stages of the pandemic as it pursued a zero strategy Covid. But many countries which, like the UK, have experienced prolonged shutdowns and pressure on health services have seen strong recoveries. The ABPI report focuses on Spain, saying that the commitment of the Spanish government to invest in research and development in the coming years and the streamlining of approvals and site installation processes had makes the country a destination of choice for clinical research.
There are signs the UK could follow in Spain’s footsteps. In March, the government said that deepening clinical research within the NHS was a key theme in its vision for the future of the sector, and the health and care bill, which is currently underway. review in parliament, could prove to be a useful legislative lever to make the objective a reality. In addition, in the autumn budget, Chancellor Rishi Sunak announced a commitment of £ 5 billion in health-related research and development spending by 2024/2025.
Meanwhile, Harris believes the successes of UK Covid-19 research following the MHRA’s pragmatic approach to regulating Covid-19 research and the urgent health badging process public to prioritize studies have demonstrated the potential impact of procedural reform for non-Covid-19 trials.
“During the pandemic we have shown what we can do when we work together more closely and are more pragmatic and now we have a UK wide vision for clinical research,” she said. “If we continue to work with the Department of Health on this vision, I see that we will be able to advance these new ways of working in other areas of the disease. But a caveat about this is that if the NHS can’t recover we’re going to be stuck in this rut of an NHS that can’t do much research for years to come.
Harris says streamlining regulatory processes would not only make the UK a more attractive destination for clinical research, but also allow the UK to improve enrollment levels – an area in which it is currently lagging behind by compared to other countries.
“One of the things we’ve seen in other countries is that they have incredibly streamlined processes for getting regulatory ethics approval up to a site ready for the patient’s first visit,” Harris said. “Right now we have pretty long lead times for this whole process, so for a multi-country international global study, if you spend a lot of your window on setup, you don’t have a lot of time to recruitment.”
Average enrollment levels in the UK were already relatively low before the pandemic and although Covid-19 had only a slight impact on enrollments in Australia, China and the US, enrollments in the UK -Uni have declined further. Since the start of the pandemic, the average number of UK participants in Phase I trials has been less than half of those in the US and China.
As a result, UK trials are more likely to be well below their target recruitment levels. Since 2018, the UK has had the highest proportion of trials below 50% of target recruitment across all major clinical research markets. In the UK, low participation was a particular challenge for Phase II and III trials, with 13.7% of these trials recruiting less than half of their target recruitment levels.
Harris believes the Covid-19 trials in the UK have demonstrated another opportunity to increase enrollment. During the pandemic, sophisticated data tracking, combined with a proactive approach within the NHS, combined to enable more effective identification of the ‘right patient at the right time to get involved in the right trial’.
“I think the attitude of the NHS was ‘we have to do this because it’s really important’, and that led to an approach where many sites basically spoke to every Covid patient who came in and asked questions on research participation, ”says Harris. “We don’t have that for other disease areas, so open that dialogue with patients and ask ‘do you want to get involved? Is really valuable.