The National Institute for Health Research (NIHR) strongly welcomes the Life Sciences Sector Deal 2, and remains committed to achieving the ambition set out in the Life Sciences Industrial Strategy to make the UK a top tier global hub for biomedical and clinical research and medical innovation.
The NIHR funds, supports and delivers high quality research; engages and involves patients, carers and the public; attracts, trains and supports the best researchers; invests in world-class infrastructure and a skilled delivery workforce; and partners with other public funders, charities and industry. It is funded by the Department of Health and Social Care. Through the NIHR, Government have awarded more than £950 million investment in research infrastructure in the NHS to translate findings from basic science to patient and healthcare benefit.
At the core of NIHR is collaboration. The relationships forged between the NIHR, NHS and Universities, the pharmaceutical, biotechnology, medical device and diagnostic companies, and contract research organisations are critical to improving the health and wealth of the nation through research.
Together we have already made significant progress. Implementation of NHS England and the NIHR’s commitments to 12 Actions to support and apply research in the NHS has simplified processes for NHS research through a standard costing methodology and a model site agreement, and we are beginning to implement a single contract review to increase transparency and reduce variation. We have also removed the 70 day benchmark for clinical trials in favour of the publication of accurate performance data using a standard national framework, and changes to HRA Approval processes have improved timelines for research approvals.
However, we can do more. The Sector Deal announced a suite of measures to make our clinical research environment faster, more efficient, streamlined and innovative, including plans for the NIHR Clinical Research Network (CRN) to establish five purpose-designed centres dedicated to late-phase commercial research in 2019/20. These centres will offer rapid set-up of late phase commercial research, standardised contracting and delivery approaches where appropriate, and dedicated facilities and staff. By increasing the NHS’s capacity to deliver research, they will enable significant growth and provide more opportunities for patients to benefit from early access to innovation.
We are committed to improving the speed and efficiency of clinical research delivered across the NHS, exploring ways in which NHS workforce resource challenges can be addressed in commercial contract studies, and mechanisms which ensure more patients can be offered the opportunity to participate in clinical research of relevance to them, whether or not it is being delivered by their regular healthcare provider, to speed up recruitment and increase patient access.
The Life Sciences Industrial Strategy proposed that the UK should attempt to lead the innovation in clinical trial methodology. The Complex Innovative Design (CID) Trials report from the Clinical Research Working Group, a partnership between industry and government, highlights innovation in trial design in the UK and identifies where more progress can be made. The Sector Deal commits to making delivery of these studies ‘business as usual’ across the system, and supporting the life sciences industry, including SMEs, to access early advice to support the design of innovative trials.
Significant expertise in innovative trials exists across NIHR, in our early translational infrastructure (NIHR Biomedical Research Centres, Clinical Research Facilities, and Experimental Cancer Medicine Centres) as well as NIHR CRN supported research sites in the NHS. We will make available details of these expertise, making it easier for industry to identify opportunities for collaboration and select research sites. We are also committed to increasing expertise in innovative trials across the research community, and will work with partners to deliver a skills package to increase expertise in innovative designs and embed expert understanding of how innovative studies can be run across the NHS.
The Government is also investing in the infrastructure needed to support the expansion of digitally-enabled clinical research, including real-world studies. Our shared vision is to make the UK the home of scientific and technological advances in healthcare, delivering the very best treatments to UK patients and making the NHS more efficient. This is coupled with major new commitments to develop a first-of-its-kind, world-leading cohort of healthy participants, which will enable research into the hidden signs of disease and the development of tools to detect and diagnose diseases earlier, and a commitment to sequence 1 million whole genomes in the UK within the next 5 years.
NIHR is an enthusiastic partner in this developing infrastructure, able to work with Industry to design studies which utilise these data and infrastructure effectively. We are working closely with Health Data Research UK, NHS Digital and NHS England to ensure a joined-up UK data offer.
We welcome this exciting package of improvements and innovations and believe it will enable the UK to realise the potential of cutting-edge technological developments for the benefit of the UK population, patients, the NHS and the economy.