Clinical research is the most expensive and often most time-consuming phase of drug development. This fact puts huge commercial pressures on businesses and, in turn, can be a barrier to promising new drugs reaching patients. These increasing costs and ever narrowing commercialisation windows can quite easily ground new drugs early on in development.
The current pandemic has added an additional layer of pressure on businesses developing new drugs. Large numbers of trials around the world have been placed on hold, with clinicians focusing their time on front-line care and urgent COVID-19 research. Access to non-COVID-19 patients for research has also been affected, with national lockdowns and near-capacity hospitals resulting in patients staying at home. What lessons can be learnt from the prioritisation, set-up and delivery of COVID-19 research going forward?
On the face of it, the picture looks bleak. However, clinical research is advancing and, in fact, the pandemic has meant that many advancements have been accelerated. Over the last 10 months the United Kingdom’s (UK) research system has shown what is possible; a single, collective system-wide approach was set up, bringing together the National Institute for Health Research (NIHR), Public Health England, UK Research & Innovation, Health Research Authority, Medicines and Healthcare products Regulatory Agency (MHRA) and others, to facilitate the rapid prioritisation, set-up and delivery of COVID-19 research. This has enabled some studies to progress from prioritisation, regulatory and ethical approval, to first patient recruited within days, rather than the many months it took before. The use of platform trials, adaptive trial design and virtual trials have also been essential during this period, enabling the system to evaluate innovations rapidly.
The UK is recognised worldwide as a leading destination for clinical research. However, the country knows it must continue to evolve to keep up with the competitive market and changing research needs of new medicines. Through the UK’s Life Sciences Industrial Strategy, Sector Deals and R&D Roadmap, the UK Government has committed to enhancing its clinical research system, addressing many of the challenges industry faces.
“Clinical research is advancing, and, in fact, the pandemic has meant that many advancements have been accelerated”
One such mechanism of achieving this change is through the NIHR. The UK Department of Health and Social Care (DHSC) invests over £1.2 billion annually through the NIHR to fund translational, clinical and applied health research spanning the whole innovation pathway. This investment funds the people, research programmes, centres of excellence and systems, across the UK’s health and care system and leading universities, making it one of the most integrated health research systems in the world.
The system has already been focused on tackling many of the challenges around clinical re-search, accelerating its set-up and delivery. The NIHR Clinical Research Network, which has been a core part of the NIHR since its establishment in 2006, links sites across the UK’s National Health Service (NHS) into a network that allows set-up and delivery of research across the country’s entire health and care system. Working closely with industry, the NIHR has continued to embed improvements in research delivery year on year. Some of these include the national costing template, multi-site contracting templates, and pre-formed national collabo-rations allowing rapid access to the country’s leading expertise.
More recent advancements include the establishment of five NIHR National Patient Recruitment Centres, allowing for streamlined set-up and delivery of late phase commercial research.
As well as continuing to commit more funding to research infrastructure, the UK Government has also increased the amount of funding available to researchers through the various funding programmes it deploys. The NIHR, for example, now has eight different funding programmes that can support innovators to translate and evaluate their therapeutics within the NHS and social care.
Advancements at a glance
The Combined Ways of Working pilot:
Bringing together a single Clinical Trials or Medicinal Products application for Clinical Trials Authorisation and Research Ethics Committee opinion.
MHRA Scientific Advice service:
Allowing companies to gain early advice from the regulator.
National Institute For Health and Care Excellence’s (NICE) Office for Market Access:
Providing advice to innovators around evidence requirements.
The Accelerated Access Collaborative:
Hosted by NHS England, this will bring together industry, government, regulators, patients and the NHS to remove barriers and accelerate the introduction of ground-breaking new treat-ments into the system.
MHRA Licensing and Access Pathway:
Accessed via an ‘Innovation Passport’, development of new therapeutics will be sped up by as-signing a unique roadmap towards market access for that therapeutic, along with allowing the company access to support tools.
The UK research system knows it cannot stop there and is continually advancing the way research is conducted. Technologies such as wearables, remote monitoring, decentralised data repositories and digital diary cards enable some trials to move virtually, allowing patients to get involved in research without travelling to a clinical site. Embedding innovative trial designs more broadly across research allows trials to flex in real-time so endpoints can be achieved in the shortest length of time. Centres and systems are being put in place to enable rapid access to health and research data, access to large, highly-characterised and pre-consented patient cohorts, as well access to leading expertise from across the country to support and collaborate with businesses. Finally, funding programmes are adapting to become more attractive to businesses, including the use of rolling calls and speeding up the application process, busting bureaucracy.
This pandemic has shown what is possible, with lifesaving vaccines and therapeutics being accelerated through the clinical phases and approved by regulators within months, not years. We should be proud of what has been achieved within this time, but it is more important to ensure we take what we’ve learnt and developed from the pandemic and embed it into our future clinical research system for the benefit of patients.
Dr Peter Sargent is Head of Business Development at the NIHR. Go to www.nihr.ac.uk