Published: 26 May 2023
The NIHR has welcomed Lord O’Shaughnessy’s independent review into the commercial clinical trials landscape. The review sets out the actions needed to address key challenges within the system and reflect the work well underway by NIHR to create a thriving clinical research system fit for the future.
The NIHR has been at the forefront of the UK’s vision to transform the future of research delivery and has already delivered real change across the clinical trial system to help build back a thriving competitive life science sector.
Professor Lucy Chappell, DHSC’s Chief Scientific Advisor and NIHR CEO, said:
"The UK has an excellent track record when it comes to clinical research. Lord O’Shaughnessy’s review highlights priorities where we can do even better. We delivered record amounts of research in the COVID-19 pandemic to enable treatments for patients at pace and scale. We are now rebuilding the research portfolio to enable an effective, efficient, and innovative health research system to improve outcomes for people across the NHS.
"Through acting on the key recommendations within the review, we can enable more clinical trials to be conducted in the UK, ultimately leading to more lives improved and saved through innovative interventions."
Sine Littlewood, NIHR Clinical Research Network’s Director of Business Development and Marketing, said:
"Lord O’Shaughnessy’s review sets out some clear focus areas for the improvement of commercial clinical trial delivery reflecting much of the work NIHR has been undertaking to meet these challenges.
"NIHR’s programme of work means we are moving more quickly towards a more innovative, more efficient and inclusive health research system that will improve lives for people all over the UK. Through this sustained focus and collaboration with partners across the research community, we look forward to making further progress through the UK Clinical Research Recovery, Resilience and Growth (RRG) programme."
Transformative change underway:
Making it easier for patients to take part in research
NIHR’s Be Part of Research service makes it easy for people across the UK to take part in research, and for the life sciences industry and health charities to find volunteers for studies quickly and effectively, with a free of charge match-making and information service. It is now available through the NHS App in England making it even easier for people to find and register their interest in research opportunities, as well as the NHS website home page, visited over 55 million times each month. 150,000 people have now signed up to the new registry service that researchers can use to find potential participants.
Be Part of Research has been developed to make it more people-centred and accessible for everyone, helping to improve inclusion and diversity in research participation. On the Be Part of Research website, people can search for what trials and studies are taking place for particular health conditions they are interested in, and at locations that are easy for them to get to, as well as search for virtual opportunities that can be carried out from home.
Improving efficiency of research set up
NIHR, together with NHS England and Devolved Administration partners, worked together to streamline contracting for commercially sponsored research through the UK National Contract Value Review (NCVR). NCVR enables NHS organisations and the life sciences industry to apply a UK-wide, standardised, approach to costing and contracting for commercial contract research, increasing the speed and efficiency of research set up and increasing capacity for more research in the NHS.
Data from the first six months of the National Contract Value Review process shows that, on average, commercial studies are achieving study set-up milestones 95 days quicker. Before this new process was introduced, it was taking an average of 7 months to complete costing and contracting as part of the 'set-up' activities for a clinical trial or study. For studies completing the new process that average figure is now 4 months.
Since the process became operational in October 2022, over 500 commercial studies have now entered into the National Contract Value Review process. This equates to approximately 83 studies per month. Over 220 studies have completed the Study Resource Review phase of the process and are now in the site contract negotiation phase. This involves over 2000 sites.
Strengthening the research workforce
A new UK-wide professional accreditation scheme for Clinical Research Practitioners (CRP) was launched as part of efforts to double the number of this important workforce over the next few years. In England, CRP-eligible roles make up around 25% of the NIHR Clinical Research Network’s funded workforce, working alongside 5,000 research nurses to deliver the safe, ethical and high quality clinical research care that is transforming patient care and treatment. The introduction of the register will improve professional identity, recognise the vital role CRPs play in research delivery, and provide a clear path for the career development of CRPs.
The NIHR Associate Principal Investigator Scheme was also launched to make research a routine part of clinical training, to develop health and care professionals to be the PIs of the future and to recognise and promote health professionals’ engagement in NIHR portfolio research in a consistent manner.