Suki Balendra PhD has a long and distinguished background in healthcare and research, spanning academia, industry, central government and the NHS. Her current roles include Life Sciences Lead for North West London National Institute for Health Research (NIHR) Clinical Research Network (CRN), Director of the North West London Clinical Trials Alliance, and she also acts as an advisor to the IgniteData Board.
In this guest blog, Suki talks through the current clinical trial landscape in the UK, from the viewpoint and priorities of four of the key players: the UK government, the NIHR, clinical trial sites and industry.
The influence of government
Life sciences is a dynamic, collaborative and forward-thinking sector, fusing science, innovation and technology to help solve the global healthcare challenges of our time.
The government’s 2021 publication of the Life Sciences Vision recognised the importance of the sector and the opportunity to capitalise on the UK’s reputation. It highlighted how clinical research is fundamental to healthcare innovation – it is the single most important way we turn cutting-edge science into more effective diagnosis, treatment and prevention.
However, as reported by the ABPI, the number of clinical trials started in the UK each year dropped by 41% between 2017 and 2021, posing a very serious threat to the UK’s reputation as a place to conduct clinical trials. The report by the ABPI said the drop in clinical trial activity painted a concerning picture.
It’s clear that industry is finding it challenging to conduct clinical trials in the UK. One of the issues that seems to be feeding into this trend, is the time it takes to set up a clinical trial. While the UK did very well quickly setting up Covid research and vaccine trials, since then recovery overall has been slow.
To help combat this, there is a real focus from the UK government on the Research Reset Programme. The programme is led by DHSC with representation from across the research community. The programme aims to free up capacity across the research system, by working with funders and sponsors to support the review of studies that have already completed, or that are unlikely to deliver their end points in the current environment.
As well as these efforts to reset the UK clinical trial landscape, the government has made it clear that it has a more ambitious vision for a digitally enabled, pro-innovation and people-centred clinical research environment.
So, there is plenty being offered to encourage innovation, specifically digital innovation. In March 2022, we saw commitments that up to £200 million will be invested to provide research with better access to NHS data. This was quickly followed up in June with a 3-year implementation plan that promised an extra £175 million. In particular, funding streams and grants are being offered to smaller companies looking to offer their innovations to the NHS. Those ready to deploy emerging technologies are seen as critical to achieving the vision for faster, higher quality clinical trials.
The final remaining piece of the government’s vision is the person-centred aspect. Ensuring diversity in clinical trials, so that our clinical trials reflect the makeup of our population, is something we’re increasingly hearing very strongly from the government. I’ll talk more about this later!
The NIHR’s role
At the NIHR, our role is to support the research infrastructure side of the NHS. The ultimate goal is to maximise the opportunities for patients to get involved in clinical research. The priority areas align with those set by the government, for example, supporting the government’s Research Reset Programme and increasing diversity in the clinical trial landscape are both key areas of focus. The NIHR are also responsible for distributing an additional £150 million of the £175 million funding announced in June 2022 (mentioned above), including via investment to support NHS R&D transformation.
The view from trial sites
For clinical trial sites in the NHS, the challenges aren’t just about being able to take risks, however. Staffing is a major issue, as we’re seeing staff leave the NHS. From conversations with colleagues, this seems to be a nationwide issue that is being acutely felt in London.
In my current role with the NIHR Clinical Research Network, I’m involved in recruiting staff to support the clinical trials landscape. In the past, we would have to put a cap on the number of applicants we could accept. This is no longer the case!
While this is affecting all trial stages (an example being research nurses, who are critical to the whole delivery of clinical trials), the pressure is being felt most keenly at the early stages of setting up trials. The lack of bodies on the ground to work through the approvals and governance stages means that there are real challenges with getting new trials up and running.
Yet, there’s no lack of willingness from NHS sites to conduct clinical research. In my patch in North West London, for example, I see real interest in working with the life sciences industry to build their portfolio of commercial trials. The desire is there, so I have hope that the current staffing issues are a temporary blip in the grand scheme. In the meantime, I believe that these challenges may force sites into some changes that should have a positive long-term effect.
One clear example is using technology to help speed up processes and reduce manual labour that often slows progress down. Using IgniteData’s EHR-to-EDC software as an example, technology such as this could be used to greatly reduce the time researchers spend on manually transcribing clinical data, both while setting up a trial and during it. This would free up time for staff to be redeployed to support setting up new trials. That’s just one way that technology might help with being able to shift the workforce to where they’re most needed at any given time.
The role industry is playing
The relationship between the UK life sciences industry and NHS trial sites is something that gives me a great deal of hope for the future of clinical trials in the UK. I’ve never seen this level of support from industry towards the NHS, and that is hugely refreshing. From strategic partnerships, down to supplying boots on the ground, there’s a real desire to work together to address any blockages.
I also see the next year being one where we’ll begin to reap some of the benefits of the way the industry has facilitated the use of new, innovative technologies, for instance those being introduced to support more decentralised trials.
Finally, another positive shift that we’re seeing from the industry, is in an area I mentioned is an increasing priority for the UK government…
Patient diversity in clinical trials has long been a topic of discussion within the research community. Disease and illness of course do not discriminate, but our age, race and ethnicity do play a part in determining how conditions affect us. Lack of diversity in trials is a real obstacle to understanding the safety and efficacy of novel therapies across different populations, which is vital to advancing equity.
Within the last few years, there has been a real movement for change in terms of diversity and equality. Black Lives Matter protests fuelled conversations around discrimination and diversity, both within the workplace and at home. More diversification and better representation of those from traditionally marginalised communities is not now a nice-to-have, but an absolute must.
A long-standing blocker to increased diversity has been that many in the NHS, academia, community-serving organisations, and the life sciences industry struggle to establish long lasting meaningful partnerships. The North West London Clinical Trials Alliance has sought to change that paradigm. We have established a regional collaborative working model in partnership with the life sciences industry. Engagement and collaborative working between stakeholders, including community, NHS and pharmaceutical industry partners enables trust and gives an ecosystem to co-create strategies and solutions together. Leveraging partnerships between NHS, community, and industry now presents a tremendous opportunity to cultivate and sustain clinical trial diversity.
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IgniteData is the company shaping the future of clinical trials. Through our innovative eClinical platform, Archer, we are enhancing interoperability between Electronic Health Records (EHR) and key research applications such as Electronic Data Capture (EDC).
With this technology, clinical trial sites across the UK and beyond are streamlining their clinical trial processes, reducing manual labour, and freeing up resources for valuable research work.
Suki Balendra PhD
Suki is Life Sciences Lead for North West London National Institute for Health Research (NIHR) Clinical Research Network (CRN), Director of the North West London Clinical Trials Alliance, and she also acts as an advisor to the IgniteData Board.
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