13 - Clinical Research

The government is investing £7 million into the launch of five new regional Patient Recruitment Centres (PRCs) across England, to help more patients access late-stage clinical research.

The centres – at NHS Trusts in Blackpool, Bradford, Exeter, Newcastle upon Tyne and Leicester – are distributed across the country to provide opportunities for patients in regions across England who may not previously have been able to take part in cutting-edge clinical studies.
They are also set to increase opportunities for patients to access trials assessing the latest potential treatments against COVID-19 amid the current pandemic, as well as for studies across all other healthcare specialties.
According to the government, the move forms part of its Life Sciences Industrial Strategy and Life Sciences Sector Deal 2, which strives to strengthen the UK environment for clinical research and enable growth within the sector, while ensuring the country ‘is at the forefront of medical science and the development of innovative new treatments for years to come’.
The centres will expand the NHS’ capacity to deliver research for patients, while accelerating the set-up of late phase commercial trials within the health service, thus providing opportunities for patients to benefit from early access to innovation while improving the UK’s competitiveness in the global market.
“These centres give us a further dimension and opportunity to offer large scale trials, for instance in treatments for COVID-19, and to help deliver those at pace and scale. Looking further, they will help us build on our position as a great country to support life sciences research,” noted Dr William van’t Hoff, chief executive of the NIHR Clinical Research Network.
“The investment in these new centres will also significantly increase the NHS’ capacity to deliver research – benefiting the UK economy by attracting more life science investment in the UK, while creating jobs and generating income and savings for the NHS Trusts who will deliver them – a welcome boost for our country’s health service.”
The sites will be managed by the National Institute for Health Research (NIHR) and run by NHS Trusts.

How has COVID-19 affected operations at O4 Research?
At O4 Research we are accustomed to continuously challenging the status quo in order to innovate, after all our mantra is ‘not to follow a prescribed past, rather to think laterally to achieve the most effective solutions’. The combination of quality leadership and impressive team commitment ensured that we quickly and successfully adopted remote working practices for our entire office based teams. In fact, the unwavering determination and collaboration of our expert cross-functional team has facilitated adaptive study designs and mitigated the risk of further disruption to ongoing and planned clinical trials. We are confident this will help future-proof us against similar circumstances that may arise.

What lessons can the CRO industry learn from the pandemic?
The need to re-evaluate the clinical research burden on both site resource and patients. Social distancing, fear and study deprioritisation have resulted in missed visits, study pause and treatment disruption leading to non-compliance and reduced data quality. Whilst the merits of evolving towards a more digitised clinical trials era are clear, we should not lose sight of the inherent need to maintain a strong, genuine focus on the human aspect. With COVID-19, we have witnessed a reawakening of community spirit, a renewed sense of purpose permeate across society and the Hippocratic Oath has never seemed so relevant and alive as it is today. We must harness this to effect meaningful industry wide change across all therapeutic areas by capitalising on recent COVID-19 initiatives such as accelerated start-up and improved direct to patient support to help fuel the development, at pace, of life-changing treatments.

Will the pandemic accelerate the use of virtual trials?
Virtual trials have been advancing for many years and we have been actively investing in new technologies and bespoke hybrid approaches to study design but equally this evolution must be carefully controlled to ensure compliance, protect data integrity and remain end user focused ensuring that participant interactions with HCPs are maintained.

What’s next for O4 Research?
As a UK/Ireland based CRO providing full and functional services to our global and regional clients, we look forward to continuing to engage with our clients and advocacy groups and implement bespoke targeted and quality focused solutions, while keeping our patients at the heart of our thinking.

Gov’t invests £7m in patient recruitment centres

PharmaTimes talks to...

Andrea Parke

O4 Research