Clinical trials of the future – a blog by Dr Janet Messer, Director of Approvals

'The COVID-19 pandemic was a hugely challenging time for clinical research in the UK. However, it showed us what the NHS, and the UK’s research systems and infrastructure can achieve under the most difficult and urgent circumstances.

We learned that giving COVID-19 research full focus and prioritisation delivered significant results but had costs elsewhere. The numerous clinical studies on COVID-19 showed us all that people want to do research and that there is great willingness to participate in it, but that patient and public involvement was not sufficiently embedded and needed extra support.

We saw researchers actively exploring new ways of working, discovering the art of the possible, and making use of the UK’s regulatory flexibility and proportionality.

It helped everyone to see the importance of a systems approach – applying systems thinking, methods and practice to better understand clinical research challenges and identify collective actions. That’s an approach that the HRA has taken from its start: working with partners to coordinate and standardise practice in the regulation and management of clinical research.

We are now at a pivotal moment for clinical research in UK where we need to build on the positive while addressing the negative. The Government’s new vision for clinical research delivery sets out where we need to be, and how we will get there.

For the first time we have all interested partners and parties working together through the Recovery, Resilience and Growth Programme with one common purpose to drive improvements across the four nations of the UK. This is a real strength, which we believe will pay dividends. Through the Recovery, Resilience and Growth Programme we seek to better understand and remedy immediate system issues but also those underpinning systemic root causes that might be preventing quicker or more impactful progress.

So, what is the HRA doing through this programme for clinical trials of the future?

First, we need to address the negative consequences of the pandemic on clinical research in the UK by supporting the recovery of research in the NHS. We’re working with others to improve clinical research delivery to time and target by identifying and removing barriers caused by governance arrangements or policy. One example is our updated guidance with Medicines and Healthcare products Regulatory Agency (MHRA) on remote monitoring of electronic health records.

We’re also working on the long-standing issues that have hampered the reputation of the UK. Study set-up in the NHS is being streamlined through our expanding suite of model agreements and the reviving of the National Contract Value Review – transparent up-front prices from NHS organisations and a single negotiation. We’re sponsoring a project with the Experimental Cancer Medicine Centres to explore radical new ways to set-up early phase cancer studies in the NHS.

We have introduced a combined review service with the MHRA. This offers a single application, combined review and decision for a clinical trial and, from 1 January 2022, will be the way all new Clinical Trials of Investigational Medicinal Products (CTIMP) applications are submitted. A fast-track ethics review option is also available. From January, we’ll be automatically registering all these clinical trials as part of our Make it Public strategy.

We’ve drawing this streamlining together as part of a UK approval system supported by developments in IRAS (the Integrated Research Application System), where researchers and companies are guided along an ideal path to provide the right information to the right place at the right time.

We’re also addressing areas where there is untapped potential. With our expertise in information governance, we’re advising on the development of a Find, Recruit and Follow-up service, which will use a suite of data and digital technologies to place trials in the right location, to recruit patients from the full diversity of the UK population, and to obtain follow-up data efficiently – all in ways that protect and promote the interests of patients and the public.

And finally, and most importantly, we want to make sure that research is available and accessible to all who choose to take part. We’ve published guidance on new models for decentralised trials, so patients don’t need to travel to a distant hospital to take part in trials. This makes it easier for patients to participate in trials and makes best use of NHS resources.

We’re developing guidance to improve diversity and inclusion in research. And we’re working to achieve a cross-sector commitment to public involvement in research, so that research is designed, delivered and disseminated with and for patients and the public.

We have an unprecedented opportunity to recover and transform the way clinical research is carried out in the UK. With MHRA, we propose to enable and embed this flexible and proportionate approach to clinical trials through revisions to our UK legislation and accompanying guidance. Together, we can all achieve innovative, patient-centred research as standard. We are well-placed, but the whole research system must work cohesively and quickly to achieve what we need to do. The time to act is now.'