Coordinating and delivering research in the pandemic: The UK approach

The acute phase of the COVID-19 pandemic tested the UK’s capacity and capability to rapidly deliver crucial clinical research at a time of immense pressure and stress on personnel and resources.

It triggered a system-wide response which took the UK’s collaborative culture to new levels. This multi-agency approach enabled unprecedented speed and efficiency in trial approvals, set-up and recruitment. By eliminating delays and duplication, and optimising all available resources throughout our NHS, the UK was able to answer questions of global importance about COVID-19, including treatment and management.

Having successfully demonstrated our ability to coordinate, expedite and accelerate research delivery there is now an opportunity to reflect on what the UK did well and what this means for the future.

 

This pharmaphorum webinar, held in association with the National Institute for Health Research (NIHR), will take place on Thursday 25th February 13:00 GMT / 14:00 CET and discuss the UK’s approach to delivering research during the COVID-19 pandemic. It will examine lessons learnt from implementing complex design trials on a national scale and question what the UK could have done differently.

Focus

The webinar will also cover:

  • How research was prioritised
  • Processes for streamlining approvals
  • Learnings on site selection and set-up
  • Strategies for successful and rapid recruitment

View the webinar* by clicking on the link in the window above or by clicking here.

Our Panel

Kirsty WydenbachDr Kirsty Wydenbach is an expert medical assessor and the deputy unit manager in the Clinical Trials Unit at MHRA, having joined in 2009. She has been involved in the UK regulation of clinical trials across all therapy areas and all phases of development, including ATMPs and numerous first-in-human studies. She has also been involved in European discussions aiming to establish an EU harmonised approach to clinical trials, particularly for Developmental Safety Update Reports (DSURs) and Reference Safety Information (RSI). She was also an EMA expert for the update of the First-in-Human guideline. Other recent work has included collaboration with external industry groups and regulators regarding adaptive and novel trial designs: she is leading on this aspect for the MHRA in order to implement that aspect of the Life Sciences Industrial Strategy and was a contributor to the EU CTFG Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials. More recently Kirsty has overseen the clinical trial work for COVID-19 and provided regulatory expertise on vaccines both within MHRA but also as part of the government Vaccine Taskforce.

Sir Terence Stephenson, Nuffield Professor, Child Health, UCLSir Terence Stephenson is an eminent clinical academic and took up the position of chair at the Health Research Agency on 1 September 2019. He is Nuffield Professor of Child Health at the University College London Great Ormond Street Institute of Child Health and Honorary Consultant Paediatrician at UCL Hospitals NHS Foundation Trust & Great Ormond Street Hospital for Children NHS Foundation Trust. Sir Terence is also a former Dean of the University of Nottingham’s Medical School, President of the Royal College of Paediatrics and Child Health, Chair of the Academy of Medical Royal Colleges, and most recently of the General Medical Council.

Professor Nick Lemoine, Medical Director, NIHR Clinical Research NetworkProfessor Nick Lemoine is medical director of the National Institute for Health Research Clinical Research Network for England. Nick has recently been appointed chair of the COVID-19 urgent public health studies group for the UK. The group’s remit is to consider all clinical studies relating to COVID-19 and to fast-track those with the greatest promise. Nick also chairs the NIHR Invention for Innovation Challenge Panel. Nick is director of the Barts Cancer Institute, Queen Mary University of London, and director of research & development for Cancer at Barts Health NHS Trust, the largest NHS Trust in the country. Among other commitments, he is the chair of Trustees of the Medical Research Foundation (the MRC’s independent charity), and executive dean of the Academy of Medical Sciences, Zhengzhou University, People’s Republic of China. He was elected as a Fellow of the Academy of Medical Sciences in 2006, and as a Foreign Academician of the Chinese Academy of Engineers in 2017.

Dominic-TyerDominic Tyer, interim managing editor, pharmaphorum [moderator] Dominic Tyer is a trained journalist and editor with 19 years of pharmaceutical and healthcare publishing experience. He serves as interim managing editor at pharmaphorum media, which facilitates productive engagement for pharma, bringing healthcare together to drive medical innovation. He is also creative and editorial director at the company’s specialist healthcare content consultancy, pharmaphorum connect.

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2020 in review: COVID-19 and patient centric clinical trials

The trials and tribulations of 2020 have brought the vital role of research, pharma, and biotech into sharp focus. But how has the push to develop treatments and vaccines for SARS-CoV-2 affected the industry’s commitment to patient centricity?

This time last year, researchers and industry players were working hard to embed patient centricity and engagement into their everyday work.

Then COVID-19 hit, and organisations big and small were forced to pivot operations to tackle the real and present danger of the pandemic. Since then, we have seen some mind-boggling scientific achievements, with innovations in vaccine development being just such one example.

But how has this global push for SARS-CoV-2 vaccines and treatments affected the research community’s commitment to patient centricity? We take a look back over the last 12 months to find out.

Green shoots of engagement

At the start of the year, the industry was busy incorporating the patient voice into trials in a bid to overcome the recruitment and retention problem – the figures showed that fewer than 5% of all those eligible to take part in research signed up, and the global average dropout rate was around 30%.

“The pandemic also accelerated the adoption of many patient centric study practices. Remote monitoring, for example, went from a nice to have to a necessity overnight.”

While the research community was aware of the benefits of patient centric trials, however, they were still unclear on how to put that into practice, said patient engagement agency, Couch, back in February.

Said the team: “In the Annual Patient Centricity Benchmark Survey, when asked about training or preparing people to behave in patient-focused ways, over half of employees from biopharmaceutical and medical device companies said: ‘We are actively looking at how to teach this to our people’.

“Only 22% selected: ‘We know exactly what and how to teach this to our people’.”

That said, the community was going in the right direction. In March, we reported on how researchers were increasingly using methods such as patient-reported outcomes, remote reporting, and lay summaries to boost engagement.

Widespread interest

But then the pandemic piqued people’s interest in medical research at previously unimaginable scale.

The RECOVERY Trial, a multi-arm RCT studying the efficacy of several repurposed treatments in COVID-19, recruited a staggering 2,000-plus people across 16 NHS sites in little more than three weeks. At the same time, thousands more signed up to report their health status to the King’s College London COVID Symptom tracker app every day.

Speaking to pharmaphorum in May, Dr Sheuli Porkess, Executive Director of Research, Medical and Innovation at the Association of the British Pharmaceutical Industry (ABPI) said, if harnessed correctly, such changes could benefit research efforts for years to come.

“The studies are being covered on the news and that’s great for letting people know how they can get involved in research right now. What’s more, that ongoing exposure to discussions around trials and what people do when they are in a trial will, in the future, help people to say ‘yes, I want to be involved’.  I think we really need to look into what it was that enabled people to sign up so quickly.”

The pandemic also accelerated the adoption of many patient centric study practices. Remote monitoring, for example, went from a nice to have to a necessity overnight. In doing so, it proved it could provide robust data at the same time as reducing participant burden.

Casualty of speed?

But while the pandemic certainly created a collaborative discovery atmosphere, it also introduced an element of intense urgency – and this has, arguably, had a detrimental effect on engagement in research.

In November, pharmaphorum reported from the Pioneering Partnerships conference, organised by the ABPI, the National Institute for Health Research (NIHR), and the Association of Medical Research Charities (AMRC). We asked if rapid progress and patient engagement were mutually exclusive.

NIHR director, Jeremy Taylor, said: “One of the consequences of the system commissioning lots of urgent COVID-19 research was that, to a certain extent, patient and public involvement got bypassed. For various reasons it was too difficult or too time consuming to do when everybody was in a frightful rush.

“Patient and public involvement turned out to be less embedded than we thought, so I think COVID has been a bit of a shock to the system. It’s made us think that maybe we have been a little too complacent.”

Lessons to learn

The last 12 months have been something of a whirlwind for everyone, but the healthcare and research community have been in the eye of the storm.

In 2021, the research community can build on the widescale adoption of remote monitoring and huge increases in study recruitment rates, but it must also put what it has learned about “doing” engagement at speed and at scale into practice.

  • Want to read more about how COVID-19 has impacted in patient centricity? Check out the latest edition of pharmaphorum’s Deep Dive magazine, which is dedicated to the topic.

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Does a lack of diversity in clinical trials reflect a lack of diversity among researchers?

Embedding diversity into clinical research does not start and end at trial recruitment – the community needs processes and institutions that reflect society and provide representation.

Greater representation among study designers, research teams, and funding committees would lead to greater diversity among research participants and help to tackle health inequalities.

Speakers at the virtual National Institute for Health Research (NIHR) Academy Members’ Conference said the inclusivity conversation had moved from “why” to “how”, and that it was time to look at wider structures.

Professor Sandra Eldridge, equality, diversity, and inclusion lead for Bart’s and the London School of Medicine and Dentistry, said:  “I would suggest that the reasons our trials are not as inclusive as researchers would like are related to wider societal issues.

“Clinical trials are part of research, and research is part of society. While we may be able to improve things through trial design, we certainly can’t solve all the issues just by doing that.”

The barriers are multiple, she went on, citing a lack of trust in experts, institutions, and authority among some groups, which can be seen in current concerns over COVID-19 vaccines, and in the research process as a whole.

“The literature shows that people who feel this lack of trust acutely use words like ‘discrimination’, ‘deception’, and ‘exploitation’. They also talk about the idea of researchers being parachuted in to do research, without really involving or getting to know the group,” said Prof Eldridge, adding that there were a number of reasons for this mistrust.

“Clinical trials are part of research, and research is part of society. While we may be able to improve things through trial design, we certainly can’t solve all the issues just by doing that.”

“The first is historic racism in research, such as the infamous Tuskegee experiments, and the racism that people experience within the health service and wider society.

“Also, I think there is a lack of knowledge about research processes and safeguards among the general population and, coupled with that, a suspicion of large rich organisations such as drug companies.” Importantly, she went on, there is a “lack of visible role models within established research”.

Equality versus equity

Representation among research teams and funding committees is crucial to building processes, institutions, and interventions that work for the whole of society.

Achieving this means actively seeking out people in previously marginalised groups and making sure their voices are heard, said Professor Lucy Chappell, NIHR research professor in obstetrics at King’s College London.

Prof Chappell said: “We talk a lot about equality and that’s important. But perhaps even more important is equity – how are we genuinely ensuring everyone has an equitable opportunity to apply for research, lead research, and be on decision making bodies?

“If we put out adverts for funding committee members, for example, and are surprised when we don’t get a balanced representation of applicants, we need to ask ourselves what we are doing within that process that systematically prevents or discourages certain groups from applying.”

Gender and ethnicity are not the only considerations, she went on, adding that cognitive diversity, or the meeting of multiple – even conflicting – representative perspectives, was also crucially important.

“If I have a lot of intelligent people together in a room but they all have the same view, I’m not going to get diversity. It’s not about having clones or a tick box exercise, it’s about having diversity in the way people approach problems.”

In the same vein, research institutions should be looking for passion, ahead of the usual accomplishments and awards in their staff, said Prof Jill Manthorpe, director of the NIHR Health and Social Care Workforce Research Unit.

“Passion is the prod that makes people say: ‘but what about patient views, what about the views of the people we’re not hearing?’ Passion enables people, and spurs them to go the extra mile,” she said, using examples of community work and volunteering.

“It’s about long-term relationships, not just parachuting in for a project. It’s about what we as researchers can bring to communities, and how enriching that is for us over the years.”

The 7%

Policies and tools to help organisations build ethnic diversity into processes, such as Trial Forge’s INCLUDE Ethnicity Framework, have been launched in recent years. What is less easy to pin down, though, is socioeconomic background, said Prof Manthorpe.

She pointed to the “7% problem”, referring to the 7% of people attending fee-paying schools who also hold most of the UK’s top jobs.

“How do we find and encourage people who didn’t have those educational opportunities? How do we differentiate between people who have had a very privileged education, from those who haven’t had the ability to build up robust networks early on in life?”

Older methods of establishing background, such as the age at which someone left school or whether they had an outdoor toilet growing up, are increasingly outdated and irrelevant, she said.

“We don’t know the answer as to how do you work out people’s socioeconomic status in a respectful and easily accomplished way.

“But I hope that we will get more people engaging with this, helping to answer some of those questions on how we reach people who are perhaps the hardest to hear,” she said, adding that all researchers wanted to “extend the ladder” to those who follow them.

Representation

There is lots of discussion about making research more diverse, and various initiatives have sought to alleviate the problem that can lead to devastating health inequalities in recent years.

But by making processes and infrastructure more inclusive, researchers will no longer need to worry about reaching underserved communities to make sure their interests are represented – because they will be part of them.

About the author

Amanda Barrell is a health and medical education journalist, editor and copywriter. She has worked on projects for pharma, charities and agencies, and has written extensively for patients, healthcare professionals and the general public.

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An introduction to the new NIHR National Patient Recruitment Centres

A new network of patient recruitment centres is set to shape the future of commercial clinical trials in the UK by offering new approaches to conduct late-phase, large-scale research projects. In a recent pharmaphorum webinar leaders from the NIHR’s five National Patient Recruitment Centres (NPRCs) outlined how they could bring cutting-edge therapies to greater numbers of UK patients.

The NPRCs are one of the Sector Deal 2 commitments from the government’s Life Sciences Industrial Strategy and are the first centres to be funded by the NIHR that are 100% dedicated to delivering commercial research.

The regional centres have been distributed across the country to provide opportunities for patients in areas of England who may not previously have been able to take part in the latest clinical studies.

They have also been designed to improve the speed and consistency through which commercial research is delivered in the NHS.

The goal is to attract life sciences R&D projects by making it easier and quicker to deliver commercial research, in turn improving the UK’s competitiveness in the global market.

pharmaphorum’s webinar, held in association with the NIHR, featured contributions from the directors of the NPRCs, the medical leaders who are leading the programme.

Dr William van’t Hoff, chief executive officer of the NIHR’s Clinical Research Network, began proceedings by highlighting some of the successes that have already been achieved.

“Our aim is to establish a relationship and build trust with our local community, to develop understanding, reduce the fear of research and increase engagement in that way”
Yan Yiannakou

These include the delivery of COVID-19 vaccine trials and one of the UK’s first fully virtual interventional commercial clinical trials.

These studies have been made possible by the franchise-like operating model underpinning the network, which allows them to work in a harmonised manner, he said.

Franchise like operating model and collaborative working

The NIHR has provided £1.3 million in funding to each centre over three years to support their activities. Their collaborative model means the NPRCs will operate in an identical manner, offering a number of advantages to study sponsors.

As pointed out by Dr van’t Hoff, there will be a consistency of approach that could boost the UK’s competitiveness in a global market for late-stage clinical trial research.

The centres will benefit from shared standard operating procedures and will collaborate with each other as they host trials, the webinar heard.

Van’t Hoff said: “Each centre will provide a dedicated space and facilities for commercial clinical research, guaranteed access to NHS services to support research delivery, access to NHS clinicians to work as investigators, and a team of dedicated and highly-skilled research delivery staff to conduct the trials.”

Helen Quinn, director of the Joint Office for Clinical Research (University of Exeter and Royal Devon and Exeter NHS Foundation Trust), added that the centre in Exeter has been able to work with others across the country, costing and contracting for commercial research studies in a swift way.

“We can set trials up quickly for our patients, which is the most important consideration for us,” she said.

Speed, ease and volume

Using a franchise like operating model with standard operating procedures can speed up patient recruitment because of improved efficiency.

This was demonstrated by the swift set-up of a phase 3 COVID-19 vaccine study, which took just two weeks to set up and launch with over 1,900 patients recruited across the three NPRCs involved when it closed.

Dr Gavin Galasko is a consultant interventional cardiologist and director of research, development and innovation at Blackpool Teaching Hospitals NHS Foundation Trust, home to the Blackpool Patient Recruitment Centre.

He said: “We were the first in the world to recruit to this phase 3 study. We want to be there for pharma to show that the UK is a place to offer these latest state of the art late phase commercial studies that we can get to the patients quickly, efficiently, and in high numbers.”

Dinesh Saralaya, director of the NIHR Patient Recruitment Centre in Bradford, added that another factor that can allow trials to be quickly set up is the unified approach to costing across all the centres.

Each centre is also supported by research nurses, pharmacists and other research support staff who are dedicated resources available to the commercial trials run at the sites.

NPRCs are entirely focused on commercial research, further reducing the time to set up trials, the webinar heard.

The ‘recruitment engine’

Each centre is also driven by a ‘recruitment engine’ that uses several proactive strategies to reach out into the local community to empower patients to take part in, and to volunteer for, research.

As well as being linked to large hospitals, each centre will also collaborate with other healthcare organisations across primary, community and social care.

They can interact with primary care networks and integrated care partnerships (ICPs) for example to recruit from the local population.

This can help them find trial participants who are not hospitalised but who live with common chronic conditions and are not presenting in secondary care.

At the same time they benefit from links to large hospitals and their experience and expertise.

The centres can easily link with a wide network of GP surgeries and other local healthcare organisations, using linked NHS data sets to help identify patients to take part in research.

Yan Yiannakou, clinical director of the Newcastle NPRC, said that rather than going to a single GP surgery with 5,000 patients on its books, the centre works with federations of surgeries with 250,000 patients.

He said: “By working with a single point of contact in that federation and by working with the core federations around Newcastle, we can cover a population of 650,000 with a single search.”

Driving innovation

Other innovative strategies employed at the NPRCs include virtual consultations, something that many other organisations have tried to implement but not succeeded.

Recruitment is further aided by digital consent, data capture and online eligibility checks, with the model already leading to a ground-breaking virtual trial, possibly the first in Europe.

Yiannakou said that the model has already been used to conduct a virtual trial in irritable bowel syndrome with diarrhoea (Relieve IBS-D).

The trial is currently recruiting 10 patients a week, which is twice as many as was being recruited by 28 sites before the study went virtual.

It’s just one of several innovative approaches to patient recruitment that are being explored at the NPRCs.

NIHR

Yiannakou said:Our aim is to establish a relationship with our local community, to build trust with the local community, to develop understanding, reduce the fear of research and just increase engagement in that way.”

Other approaches to recruitment will be explored, aiming to put patients and their needs at the centre of the process.

Melanie Davies, professor of diabetes medicine at the University of Leicester and director of the NPRC in Leicester, said: “This is all about bringing research closer to patients across the patch, across the NHS, but to provide it in a way that is attractive and accessible to patients.”

The cutting-edge of global life sciences research

A theme running all the way through the webinar was the sense of collaboration that each centre will bring to research projects.

The NPRC clinical directors all highlighted the centres’ ability to work together and with the wider healthcare ecosystem, such as primary, community and social care to enable access to a wider cohort of patients.

Yiannakou said: “The key is a willingness to develop and a willingness to change, and we have both the drivers and the substrates for that. The drivers are the fact that we are a novel concept centre, that we specialise in a particular area.

“We want to be the best in that area, we are focused in that area, and we have a remit and an intent to refine process and improve recruitment.”

According to Saralaya, the centres are sending a “strong message” to industry about the UK’s intent to be at the cutting edge of global life sciences research.

He said that the work already under way at the five centres shows they can deliver trials at speed, with quality and with very unified costing.

He concluded: “What better advocate can it be for a sponsor wanting to come to the UK?”

About the interviewees

Helen Quinn is the director of the Joint Office for Clinical Research, a collaboration between the University of Exeter and the Royal Devon and Exeter NHS Foundation Trust.

 

Dinesh Saralaya is a consultant respiratory physician and honorary senior lecturer at Bradford Teaching Hospitals NHS Foundation Trust. He has served as Director of the National NIHR Patient Recruitment Centre, Bradford since June 2020.

 

Yan Yiannakou is a consultant gastroenterologist and Clinical Director of the NIHR Patient Recruitment Centre (Newcastle).

 

 

Melanie J Davies is Professor of Diabetes Medicine at the University of Leicester and an honorary consultant diabetologist at the University Hospitals of Leicester NHS Trust.

 

Dr Gavin Galasko is a consultant interventional cardiologist and the director of research, development and innovation at Blackpool Teaching Hospitals NHS Foundation Trust.

 

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Increasing patient engagement with UK clinical trials

Pharmaceutical companies often struggle to actively involve patients in the design phase of clinical trials but doing so can have huge benefits for the sustainability and success of research.

It can help address well established issues with studies, such as patient recruitment and retention, as well as reducing the need for additional trial protocol amendments. Now, patient engagement is becoming even more relevant, with the COVID-19 pandemic heralding a major shift towards remote, virtual and hybrid clinical trial models.

The regulatory issues of how to engage with patient organisations and involve patients in clinical trial design are covered by publications such as the ABPI’s Code of Practice. However, the implementation of these while maintaining compliance with internal company guidelines can prove challenging and can be difficult to navigate without support and guidance.

So, working together with patients, research clinicians and Pfizer, the NIHR has collectively agreed a way in which it can facilitate patient engagement, remain aligned with ABPI and AMRC Codes and help to manage the burden faced by life sciences companies.

 

This pharmaphorum webinar, held in association with the National Institute for Health Research (NIHR), takes place on Wednesday 16th December, 11:00 GMT / 12:00 CET and will look at how to navigate the compliance pathway to increase patient engagement with clinical trials.

Focus

The webinar will also cover:

  • Building better relationships between pharma/CROs and patient advocates
  • Improving the design of commercial research by listening to the patient voice
  • Gaining patient input on marketing and recruitment materials
  • How the NIHR’s Patient Engagement in Clinical Development service can help

View the webinar* by clicking on the link in the window above or by clicking here.

Our Panel

Sophie Evett is the feasibility lead within the Pfizer Study Optimisation group. She holds a Bachelor’s degree in Biological Sciences and a PhD in Molecular Biochemistry from the University of Reading, UK. Having worked for CROs since graduating, Sophie joined Pfizer in 2011 and has had various roles within the UK and now global groups.

Richard Stephens has survived two cancers, a heart emergency, and continued co-morbidities and late effects. He has participated in four interventional studies and nine others. A patient advocate for two decades, Richard has been involved in the design and delivery of over 30 clinical trials and studies, and has sat on many UK and European strategic bodies, including several roles within NIHR. He works with patient groups and advocates globally, with academics and industry, and with researchers and clinicians. An international key opinion former, Richard is the founding co-editor of the Journal of Research Involvement and Engagement, chairs BBMRI-ERIC’s Stakeholder Forum, and chaired the NCRI Consumer Forum 2012-2019.

Keith Wilson Patient AdvocateKeith Wilson is a former heart patient who has worked on a voluntary basis, over many years with various organisations and researchers, promoting Public and Patient involvement to enhance the clarity of documentation and participation in Research. In 2014 Keith was fortunate to become a full-time salaried patient research ambassador at Liverpool Heart and Chest Hospital Trust. Embedding the patient voice not only in research, but everything they do.

Gareth Powell, Business Development Officer for NIHR Clinical Research NetworkGareth Powell is a business development officer for the NIHR Clinical Research Network (CRN). Gareth facilitates key discussions between industry and the Clinical Research Network, and is a point of contact for life sciences companies engaging with the Clinical Research Network’s Study Support Service to ensure clinical studies are set up efficiently, and recruit to time and target. Gareth has been with the Clinical Research Network since 2009. Before joining the Business Development and Marketing Team, Gareth previously worked within the Research Delivery Directorate. He was responsible for supporting interactions between the life sciences industry and the NIHR National Speciality Groups across seven therapeutic areas, providing operational support through feasibility, set-up and patient recruitment.

Dominic Tyer, Creative and Editorial Director, pharmaphorumDominic Tyer, interim managing editor, pharmaphorum [moderator] Dominic Tyer is a trained journalist and editor with 19 years of pharmaceutical and healthcare publishing experience. He serves as interim managing editor at pharmaphorum media, which facilitates productive engagement for pharma, bringing healthcare together to drive medical innovation. He is also creative and editorial director at the company’s specialist healthcare content consultancy, pharmaphorum connect.

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Government needs strategy to kick-start R&D after COVID, says pharma body

The UK has been leading research into the COVID-19 outbreak, according to the country’s pharma trade body, but there needs to be a strategy to restart trials into other diseases.

The Association of the British Pharmaceutical Industry (ABPI) said that restarting research into diseases such as cancer would be the first step in the journey to recovery following the pandemic.

As part of its response to the pandemic the government has set up a process for nationally prioritising and approving urgent public health research studies – but this has meant that research into other diseases has paused.

In its second annual report on the state of UK clinical trials, the ABPI compared how the UK performed against other countries in Europe and other influential countries around the world.

Latest data shows that non-COVID studies are restarting after being put on hold while many companies turned their attention to developing vaccines or therapies to counter the pandemic.

As of 9th September, data from the NIHR Clinical Research Network has shown that 45% of non-COVID studies are open to recruitment and 36% of those have been recruiting since June.

Chief Executive of the ABPI Richard Torbett said: “The UK performs very well on the world stage in clinical trials, but COVID-19 is presenting us with many challenges.

“It is crucial that the government has a plan for the safe and sustainable restart of non-COVID trials, recognising the extra pressures the NHS is facing.”

Cancer remains the top area for UK clinical trials with 226 trials taking place in 2018, with research on the immune system coming next with 94 trials.

The UK led the rest of Europe in the number of early phase 1 and phase 2 clinical trials.

In phase 3, the UK ranked third in Europe behind Germany and Spain and was fourth globally behind the US.

The ABPI noted that this is an improvement over the previous report, where the UK was ranked fifth – but this will need to improve further if the UK is to become the science superpower envisioned by the government.

Overall the US continued to lead globally in all phases of research and the ABPI pointed out that improving the number of phase 3 trials conducted in the country could have benefits for patients.

More of them would have early access to the latest and potentially life-saving therapies as a result, the trade body argued.

The NHS also benefited from £355 million in income from trials and saved £26.6 million from where trial drugs were used in place of standard.

The total amount invested by pharma in UK R&D was £4.5 billion and the life sciences industry employed over 240,000 people across 5,870 businesses, generating a turnover of £73.8 billion.

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Introducing the new NIHR National Patient Recruitment Centres

The five new NIHR National Patient Recruitment Centres (NPRCs) are set to shape the future of commercial clinical trials in the UK by offering new ways to conduct late-phase, large-scale research projects.

One of the Sector Deal 2 commitments within the Government’s Life Sciences Industrial Strategy, the NPRCs are the first NIHR-funded research infrastructure that is 100% dedicated to delivering commercial research.

The regional NPRCs have been 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 have also been designed to improve the speed and consistency with which commercial research is delivered in the NHS and, by making it easier and quicker to deliver commercial research, the NPRCs will improve the UK’s competitiveness in the global market.

This pharmaphorum webinar, held in association with the National Institute for Health Research (NIHR), takes place on Thursday 12th November, 14:00 GMT / 16:00 CET and will introduce the new NIHR National Patient Recruitment Centres and look at how the NPRCs will take a patient-centric approach to pharmaceutical research.

The expert panel will also discuss how the NPRCs will help patients benefit from early access to innovation and assist industry with new approaches to research, including virtual, hybrid and decentralised trials.

Focus

The webinar will also cover:

  • What the NPRCs’ franchise model means for research delivery
  • How the centres will provide quicker and easier clinical studies
  • How they will engage non-hospitalised patients with common chronic conditions
  • How they can serve as a test bed for pharmaceutical innovation
  • How they could facilitate clinical engagement with late-phase research

View the webinar* by clicking on the link in the window above or by clicking here.

Our Panel

Helen Quinn, Director, Joint Office for Clinical ResearchHelen Quinn is the Director of the Joint Office for Clinical Research, a collaboration between the University of Exeter and the Royal Devon and Exeter NHS Foundation Trust. Helen has previously held senior positions within the National Institute for Health Research (NIHR) Clinical Research Networks including chief operating officer and lead for nursing for the NIHR Clinical Research Network in the South West Peninsula. She has also held two national roles including director of delivery and business change director overseeing the amalgamation of the topic and comprehensive research networks.

Professor Dinesh Saralaya, Director, NIHR PRC, Bradford

Dinesh Saralaya has been a consultant respiratory physician and honorary senior lecturer at Bradford Teaching Hospitals NHS Foundation Trust since 2014. He has served as Director of the National NIHR Patient Recruitment Centre, Bradford since June 2020 and is also a visiting professor at the Faculty of Life Sciences at the University of Bradford. He leads the severe asthma service at Bradford Teaching Hospitals NHS Foundation Trust and the Respiratory Clinical Trials unit at the Bradford Institute for Health Research (BIHR). Dinesh set up the severe asthma service in Bradford Teaching Hospitals NHS Foundation Trust in 2006 and has published several of his research projects on severe asthma since then.

Yan Yiannkou, Clinical Director, PRC, Newcastle

Yan Yiannkou is a consultant gastroenterologist and Clinical Director of the NIHR Patient Recruitment Centre (Newcastle). He has been a director of R&D and has also served as regional clinical lead for commercial research for the NIHR Local Clinical Research Network (NENC). His main interest is in improving access to clinical trials through community-based participation, consent for contact registries and a digital media platform. He has used innovative and collaborative strategies to develop and refine a multi-modality ‘recruitment engine’ and led one of the UK’s first ‘virtual’ interventional trials.

Melanie Davies, Professor of Diabetes Medicine, University of LeicesterMelanie J Davies is Professor of Diabetes Medicine at the University of Leicester and an honorary consultant diabetologist at the University Hospitals of Leicester NHS Trust. She is based in the Diabetes Research Centre, University of Leicester and is also the Co-Director of the Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust. She is a National Institute for Health Research senior investigator emeritus, director of the NIHR Leicester Biomedical Research Centre and director of the Leicester Patient Recruitment Centre.

Dr Gavin Galasko, Cardiologist, Blackpool Teaching Hospitals NHS Foundation TrustDr Gavin Galasko BM BCh MA DM (Oxon) FRCP is a consultant interventional cardiologist and the Director of Research, Development and Innovation at Blackpool Teaching Hospitals NHS Foundation Trust. In 2017 he became the director of research, development and innovation for his Trust and in 2020 the Cardiology Research Team at Blackpool Teaching Hospitals won the research team of the year in the North West Coast annual research awards. He is an honorary senior lecturer at Liverpool University; an honorary senior research fellow at the University of Salford, and an honorary clinical senior lecturer at the University of Buckingham.

Dominic Tyer, Creative and Editorial Director, pharmaphorumDominic Tyer, Interim Managing Editor, pharmaphorum [moderator] Dominic Tyer is a trained journalist and editor with 19 years of pharmaceutical and healthcare publishing experience. He serves as interim managing editor at pharmaphorum media, which facilitates productive engagement for pharma, bringing healthcare together to drive medical innovation. He is also creative and editorial director at the company’s specialist healthcare content consultancy, pharmaphorum connect.

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