North West London Clinical Trials Alliance - Impact report

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Foreword

Dr Suki Balendra

Life Sciences Lead
NIHR Clinical Research Network North West London

When scientists began seeking a vaccine for the SARS-CoV-2 coronavirus in early 2020, to hope for one even by the summer of 2021 seemed highly optimistic.

But by the start of December, the developers of several vaccines had announced excellent results in large trials. And on 2 December, a vaccine made by Pfizer with BioNTech became the first fully-tested immunisation to be approved for emergency use.

In North West London we made a significant contribution to the success of vaccine trials which ultimately led to a number of licensed vaccines. The spirit of collaboration shown by everyone involved in this phenomenal effort was fundamental to the successful outcome of these vaccine trials.

We understood the urgency, we were willing to take risks and we knew the only way to deliver would be together. The Alliance was a result of all the above.

The Alliance that was born out of necessity in the pandemic, is now a great opportunity for us to learn the lessons of our success – bottling the formula we have developed to tackle COVID and applying it to all other disease areas.

North West London is one of the most diverse and vibrant areas of our capital. The main aim of the Alliance now is to work in a completely regional approach with the life sciences industry and give patients the opportunity to take part in trials relevant to the population of North West London.

About Us

NIHR Clinical Research Network North West London

The National Institute for Health and Care Research (NIHR) funds, enables and delivers world-leading health and social care research that improves people's health and wellbeing, and promotes economic growth.

The NIHR Clinical Research Network (CRN) North West London is one of 15 Local Clinical Research Networks across England. We provide researchers with the practical support they need to make health and social care research happen in North West London, so that more research takes place and more people can take part.

We collaborate with our partners across the local primary care network and in the following NHS trusts:

• Central and North West London NHS Foundation Trust
• Central London Community Healthcare NHS Trust
• Chelsea and Westminster Hospital NHS Foundation Trust
• Imperial College Healthcare NHS Trust
• London Ambulance Service NHS Trust
• London North West University Healthcare NHS Trust
• The Hillingdon Hospitals NHS Trust
• West London NHS Trust

North West London Clinical Trials Alliance

The North West London Clinical Trials Alliance is a collaboration between the NIHR Clinical Research Network North West London, the local primary care network, Central London Community Healthcare NHS Trust, and the clinical research facilities (CRFs) hosted by:

• Chelsea and Westminster Hospital NHS Foundation Trust
• Imperial College Healthcare NHS Trust
• London North West University Healthcare NHS Trust

The Alliance is dedicated to delivering commercial and non-commercial sponsored clinical trials – utilising existing and purpose-designed facilities to successfully deliver both early and late-phase research.

It aims to increase regional capacity for delivering commercial clinical research, as well as to improve the ease and speed of research delivery, patient access to clinical research and patient opportunities for early access to cutting edge treatment and therapies that are not yet widely available through the NHS.

The Alliance works collaboratively to understand the needs and priorities of life science companies. Our strong regional team ethos allows us to work in a harmonised manner across centres.

We can identify world-renowned clinicians to work as principal investigators (PIs) for studies across a wide range of specialties, and provide support from highly-skilled research delivery staff at all sites.

North West London Clinical Trials Alliance - Impact during the first year

• Successfully delivered 8 COVID-19 vaccine trials, 100% time-to-target
• Recruited over 1,600 participants
• Across 3 Clinical Research Facilities and in primary care settings
• Resulting in 4 COVID-19 vaccines approved for use in the UK
• Brought in £16,000,000 in commercial income from the vaccine trials
• 4x faster set-up - Sites took on average 19 days to set up these studies, compared with 75 days for commercial setup generally in North West London.
• 8.5x faster between set-up and first patient recruited - sites took on average 11 days from finishing setup to recruiting their first participant. The average for commercial studies in the last 5 years in North West London is 94 days.
• 100% of studies in the Alliance benefited from using North West London GPs as Participant Identification Centres (PICs). Local average is 3.4% of commercial studies using primary care as PICs.
• Alliance studies contributed 5.6% of England's recruitment. This is higher than 4.8% we contribute on average to commercial recruitment in England.
  
  

CRN Support and Infrastructure

Alliance operations and the Study Support Service

Across the world people faced a variety of difficulties during the COVID-19 pandemic. One of the most pressing challenges that faced healthcare and academia was the need for an effective treatment and method of prevention.

Locally, the Study Support Service (SSS) were charged with the pre-screening of healthy volunteers for two vaccines approved for fast track clinical trials. The requirement was to introduce, discuss, screen and book appointments on behalf of the local study team.

One of the first challenges we encountered was the lack of up to date processes during a time of national emergency. The previous guidance related to the Bird Flu pandemic over a decade earlier, which meant that a revised set of protocols needed to be drawn up. These had to take in to account revised and updated governance processes within research, the capabilities and capacity at research sites and modern technology.

The new processes successfully provided the baseline for all screening used during the pandemic and included a script, appointments booking system and appointment tracking method to ensure maximum participation.

Members of the team were provided a daily list of volunteers to contact via phone, some of which had little or no experience with discussing clinical research with the general public in a delivery capacity. This process was supported by the whole of the CRN staff, including senior management and core administrative staff.

The team also coordinated the study email address which was used to provide the public with any study resources required and to answer any queries, alleviate any fears or dispel misinformation that the public brought to our attention.

A barrier that had to be considered was the team working from home, across a large geographic area. This meant that communication and organisation was paramount and we had several meetings during the start of the process to exchange ideas and best practice. Importantly, we needed to ensure a positive and open environment to ensure that the team felt supported and team moral wasn’t affected.

Numbers of appointments, phone calls and reasons for decline were all recorded to maintain oversight of the process and evaluate its success operationally and members of the study team, Study Support Service and Strategic Workforce were in constant communication giving us the ability to react to situations as they arose or new restriction introduced by the government.

Key support

The CRN North West London provided its partners with the support and infrastructure needed to successfully deliver research during the COVID-19 pandemic, finding new ways of working and collaborating to deliver studies in record times, which formed the starting point of the Alliance.

Leadership

Decisive leadership working with Trust R&D teams and Clinical Research Facilities and the Primary Care team to set-up and deliver studies. This resulted in a 'taxi-rank' style system of allotting trials to each partner and resulted in greater collaboration. Sharing feedback from the first vaccine trial to others.

Master Confidential Disclosure Agreement (CDA)

Allowing partners to quickly share clinical trials within the Alliance which enables a first-refusal process, quicker awareness and collaboration of trials.

Upfront CRN funding for COVID-19 delivery

Financial support for the creation of two new research facilities to deliver COVID-19 vaccine trials, at London North West University Healthcare NHS Trust and Imperial College Healthcare NHS Trust. There is a beneficial legacy with the continued use of this infrastructure for other clinical trials.

Participant Identification Centre (PIC) agreement

Well established relationship with the Primary Care Network and North West London trusts with harmonised model agreement process and costs to provide PIC activity.

Process of the Alliance operations

1. Check research sites are capable
2. Check referral process in place
3. Check staff skills and capabilities
4. Highlight to priority participant groups from the criteria

Collaboration with our partners was key to the achievement of setting up these priority studies in record times.

We streamlined processes to quickly check that research sites were capable of hosting studies, assessing facilities including toilets, car parks, security and the ability to adhere to social distancing.

We ensured an effective patient referral process was in place via the primary care network and PIC activity. As well as ensuring the appropriately qualified staff were on hand to deliver the studies.

Priority participant groups were also identified and additional work was carried out to engage with these groups, including ethnic minorities, people over the age of 65, care home staff and residents, and NHS staff.

Recruitment

CRN pre-screening and booking

Research quickly became a priority at the start of the COVID-19 pandemic. Priority studies, identified as Urgent Public Health studies, required support on an unprecedented scale.

Collaboration between the Alliance partners was crucial to the success of these studies, as demonstrated in the early phase of the pandemic on studies such as the COVID-19 vaccine studies from NOVAVAX and JANSSEN.

NOVAVAX COVID-19 vaccine study

• When: September 2020
• Where: St Stephen’s Centre, Chelsea and Westminster Hospital NHS Foundation Trust
• Recruitment target: 550
• Timescale: 5 weeks

JANSSEN COVID-19 vaccine study

• When: December 2020
• Where: Charing Cross Hospital, Imperial College Healthcare NHS Trust
• Recruitment target: 400
• Timescale: 8 weeks

New ways of working to support priority research

• Pre-screen members of the public
• Plan and provide pre-screening support strategy
• Implement pre-screening support
• Send Participant Information Sheet to registered interested participants
• Book eligible participants
• Answer public queries

Staff at the CRN North West London developed new ways of working to support these studies, directly working with delivery teams in the early stages of the research. The success of working in this way on the COVID-19 vaccine studies from NOVAVAX and JANSSEN led to expansion of this support to additional Urgent Public Health studies.

Utilising new and existing resources to promote and recruit

The Alliance could access local and national resources to raise the profile of the studies it supported and to aid recruitment.

Primary Care SMS

The local Primary Care Network utilises three models of recruitment: Patient Identification, Recruitment and Hybrid.

It has the infrastructure in place to rapidly undertake searches using their database and deliver a mass text messaging service.

This allows GP surgeries to directly contact potentially eligible patients in the area. The Alliance successfully used this resource to contact and recruit members of the community to the studies it supported.

Imperial Participant Database

The Alliance had access to a participant database developed by the NIHR Imperial CRF at Imperial College Healthcare NHS Trust. This is used to contact members of the community who have expressed an interest in taking part in research.

COVID-19 Vaccine Research Registry

This national registry - developed by the NHS and the NIHR - was set-up for anyone interested in taking part in COVID-19 vaccine research to register their interest.

People on the register could be contacted by research teams and offered the opportunity to take part. The Alliance were able to make use of the Registry to support recruitment.

Communications

The NIHR Clinical Research Network implemented a new way for Communications to support the promotion of Urgent Public Health studies.

In partnership with the Department of Health and Social Care, template press releases and other promotional materials - including social media assets and newsletter copy - were made available to local teams, all using ethically approved text.

The content could be localised and shared with our partner organisations to promote studies through multiple channels.

This support was available for the studies supported by the Alliance and resulted in a number of articles featured in local media titles.

Diverse population of North West London

Statistics showed that 33% of COVID-19 patients were from an ethnic minority background, despite forming only 14% of the UK population. However, early COVID-19 vaccine studies (Oxford/AZ and Novavax) had low recruitment from ethnic minorities - 5.72% of total recruits.

There was a concerted effort in North West London to monitor and recruit from a broader population group to reflect our local diverse population. As a result, the Janssen vaccine study recruited 15.3% from an ethnic minority background - a significant improvement. The data below shows the extent of diversity in North West London.

• Population of 2,376,813
• White population is 41.9%
• Other ethnic groups is 49%
• Not stated is 9.1%
• Top 5 non-English languages spoken as first languages are Arabic, Gujarati, Romanian, Punjabi, and Polish. Each of these languages are the first language of over 40,000 people.

Delivery

CRN delivery support

Symptomatic Patient Pathway

NIHR Clinical Research Network (CRN) funding and support for additional "red-zone" facilities (e.g. pods) and processes (e.g. couriers for samples and home-visits) dedicated to research participants who were symptomatic and require testing and support which were not suitable or able to access NHS standard of care.

Strategic Workforce

A team of experienced research nurses and clinical research practitioners, the Strategic Workforce, are available to support research teams for an agreed fixed time period to assist with meeting targets.

The team were able to support the Alliance with the delivery of the Urgent Public Health studies it supported.

CRN out-of-hours phone service

The unprecedented number of participants needed in a short period of time for COVID-19 vaccine trials meant that clinical research teams would likely receive more calls and queries from participants than they would be able to manage.

This led to the introduction of an out-of-hours phone service for participant queries and symptom reporting, created by the CRN North West London.

Objectives

• To triage all inbound calls during out of working hours
• To direct participants on study pathways depending on their query and symptoms
• To be available and supportive for participants on these trials and answer study related queries

Set up process

• Practical functions - phones, phone lines, establish hours, costs, staffing interest and contracts
• Appropriate training packages and resources for staff on call
• Policy – On Call Framework agreements, rostering system to reflect additional duties

Impact in numbers

• 3 - The number of trials supported with an out-of-hours phone service
• 8 - The approximate number of calls fielded per week
• 21 - The number of weeks the service operated for
• 113 - The total number of calls triaged

Studies in the spotlight

Studies supported by the Alliance have benefited from support offered by the NIHR Clinical Research Network (CRN) North West London, both in primary care settings and in clinical research facilities.

Sanofi

• The Good Practice in North West London was the only primary care site and the largest recruiter to this study.
• CRN staff worked with the site team to identify, consent and undertake all research activities over a period of 7 visits across 12 months.
• The Good Practice secured a centrifuge and -80C freezer, which put them in good stead to deliver this and other commercial studies.

Moderna - 4th booster trial

• Recruitment has become more challenging with the later vaccine trials
• Target for Chelsea and Westminster Hospital NHS Foundation Trust was 150. They recruited 162.
• Recruitment via GP surgeries, vaccine registry, Imperial registry
• Strategic Workforce supported at the CRF
• Pre-screening and booking support provided by the CRN, as well as support to distribute the Participant Information Sheet and manage inbox queries.

The Future

Better relationships with commercial companies

There was an official launch of the Alliance in September 2021, with broadcaster Adrian Chiles as the host.

Nineteen life science companies were represented at the event. Since then, we have met 21 different life science companies as an Alliance. These discussions have led to 25 new clinical research opportunities for our partners to consider in a variety of therapeutic areas.

We are in advanced discussions with contract research organisations (CROs) to become preferred partners with the Alliance.

Prof Marta Boffito, Consultant Physician/HIV Service Director at Chelsea and Westminster Hospital NHS Foundation Trust, said:

"The North West London Clinical Trials Alliance is a fantastic example of collaborative working.

"Traditionally life science companies approach individual clinicians for their clinical trials. In 2020, the UK's global share of clinical trial recruitment was 3% - this figure has not varied much between 2012-2020, averaging at 3% each year. In contrast, Spain's global share has increased from 2.6% to 4.2% in the same time period.

"In the UK if we don’t evolve and adapt the way we work with the life sciences we will continue to be static which means our patients will miss out on clinical trial opportunities and all the benefits that brings for our patients. I am hugely supportive of this work and welcome the opportunities regional working brings for the whole of North West London."

What's next for the Alliance?

We are looking forward to an extremely bright future for the Alliance. We have welcomed Central London Community Healthcare NHS Trust and London Ambulance Service NHS Trust as new partners, and in the months ahead we plan to structure the Alliance around the geography of the North West London Integrated Care System.

In North West London we have a population of 2.4 million, with around 50% from an ethnic minority background. We are discussing a number of projects with Industry around diversity and inclusion in trials and we look forward to sharing details of those projects over the next year.

Our work is already being recognised in the wider research community. We have been shortlisted in the NIHR CRN North West London Research Awards, in the Outstanding Collaborative Working category, and recognised in the Chelsea and Westminster Quality Improvement Awards.

We have been featured in national media including the Guardian and Radio 5 Live and media platforms including MedCity and IAOCR. Recently the Alliance has been shortlisted in the New Statesman’s inaugural Positive Impact Awards, in recognition of its contribution to healthcare research. We are planning more talks and blogs to continue to keep our profile high.

We have developed a shared communication strategy for promoting studies. Taking a joint approach across our partners to raise awareness of studies using a variety of approaches including social media, local press, radio, and text messages through primary care. We plan to expand this approach to all studies where appropriate through the Alliance.

The Alliance has demonstrated an excellent past record of delivering to time and target, over-performing on recruitment for population size. We also want to focus on set up times across the partners. We have standardised the contract review and CDA timelines and are looking at harmonising more of the costing and contract review process.

North West London has access to a unique depersonalised linked data set - initially across a population of 2.4 million and scaling to 8+ million over time. We plan to use these data assets in the future to ensure robust feasibility of our trials prior to starting the trial.

The Alliance is just about to start a clinical trial in sickle cell disease across two hospitals in North West London, which was made possible thanks to close working with the life sciences industry. There are a high number of people with this disease in the region and the team hopes it will ultimately give patients a wider choice of safe and effective treatments, which is important given there have only been three main treatment options in the past 50 years.

The Alliance demonstrates the power of collaboration, in this case between NHS trusts, universities, primary care services and industry. By bringing together our collective research expertise and resources, we’re much greater than the sum of our parts and can bring the latest innovations to patients more quickly.

The Alliance has achieved so much in such a short time and we're incredibly excited about the difference we can make to patients in North West London and across the world.

Thank you to everyone across North West London who contributed to this work.

Keep in touch

• Find out more about the North West London Clinical Trials Alliance.
• Email: industry.crnnwlondon@nihr.ac.uk
• Find us on LinkedIn and Twitter