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Case study: New ways of supporting clinical studies in North West London to improve efficiency

The North West London Clinical Trials Alliance

After successfully recruiting 2,000 patients into eight COVID-19 vaccine studies during the pandemic, the newly formed North West London Clinical Trials Alliance is turning its attention to the future and how learning from the pandemic can be applied to non-COVID research.

As the COVID-19 pandemic began, Dr Suki Balendra, Industry Lead at the NIHR Clinical Research Network (CRN) North West London, realised that the NIHR and the region’s NHS Trusts needed to collaborate in new ways to deliver vital vaccine studies.

After Dr Balenda was made regional lead of the COVID vaccine portfolio in North West London, she set her mind to looking for ways to streamline the research process.

“We didn’t actually know exactly what was needed, of course — we were told that we would have to recruit hundreds of participants a week, but not the scale of the commercial element to come, or which companies the studies would come from.

“We did know that any site selected to take part in a vaccine study would be under more pressure than ever to recruit patients and complete the study at speed.”

The result was the North West London Clinical Trials Alliance, an innovative partnership between the CRN North West London, the Primary Care Network and three NIHR Clinical Research Facilities, hosted by the following NHS Trusts:

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

This collaboration streamlined the delivery of Urgent Public Health (UPH) studies in the region — research that required a ‘rapid response’ to better understand COVID-19.

“These extraordinary achievements were not just a product of brilliant science”, Dr Balendra said. “In North West London, we recognised the urgency we were faced with, and we knew the only way to deliver would be together.”

This new Alliance has proven so successful during the pandemic that it is here to stay, and will benefit future research in the region. A formal launch was held in September this year, with 100 people attending, including 19 different life sciences companies.

Dr Balenda and her team believe the benefits achieved by the Alliance could be replicated elsewhere, benefiting researchers and research participants.

What did the Alliance do?

Crucial to its success was pooling resources to support study sites.

A centralised and flexible team was created to help ease the pressures felt by study sites. The North West London team was able to offer additional support to:

  • Screen and identify participants — including many applying through the COVID-19 Vaccine Research Register and Be Part of Research
  • Provide centralised communications to patients across the region, including using text messaging through primary care/GP practices for pan-region recruitment of study participants; providing information sheets to participants; and answering email queries from participants
  • Deliver a whole new central out-of-hours service that patients could call
  • Provide support from the strategic workforce — a regional team of nurses and clinical trial practitioners that were able to deploy on site

“Setting up this support, much of it from scratch, was challenging. New relationships with research teams had to be formed quickly, to gain trust and get the message of what we were doing out there. But ultimately, we all worked hand-in-hand to deliver large scale vaccine trials safely, quickly and effectively”, Dr Balendra said.


How has the Alliance benefited North West London?

“In North West London we have a patient population of 2.6 million. We are surrounded by some of the best academic institutions and NHS Trusts. And importantly, we are ethnically diverse, with around 50% coming from a minority ethnic background.

“At a time when there is a move to shift funding away from the South East of England, I’m a passionate believer that this should not come at the expense of engaging with communities that have been underserved in the past. Although there is of course diversity in other parts of the country, London, as a whole, presents a valuable proposition for life sciences companies in the scale and complexity of diversity in our population.

“Another benefit that should not be overlooked, is our access to datasets. We’re very fortunate to have access to the WISC dataset — a longitudinal data set of primary and secondary care data, for 2.3 million people — in our patch. This data set from Discover-NOW, one of the health data research hubs, is unique in the whole of Europe, and enables us to carry out robust feasibility assessments before even starting a study.”


How the Alliance has worked in practice: The Novavax vaccine trial

Just one example of how this support came to life is the Novavax vaccine trial. It was one of the first commercial COVID vaccine trials in the UK and was hugely successful, with over 575 participants recruited in under five weeks.

“The trial was run at Chelsea and Westminster,” Dr Balendra said. “But it was a true regional effort.

“Clinicians from Imperial College Healthcare NHS Trust and London North West University Healthcare NHS Trust were involved, and of course we in the Clinical Research Network were behind the scenes working operationally to deliver the trial.

“The speed we were able to deliver the trial was unprecedented for Chelsea and Westminster, and the spirit of collaboration shown by everyone involved in this phenomenal effort was fundamental to the success of the trial. Clearly, this was something we didn’t want to lose.”


How will the Alliance benefit commercial research in particular?

Prof Marta Boffito, Consultant in Infectious Diseases and HIV, Clinical Lead at Chelsea and Westminster Clinical Research Facility, says the door is wide open for pharmaceutical companies to work with her team.

“The success of the Novavax vaccine trial is thanks to the incredible collaboration of the North West London Clinical Trials Alliance.

“It was a very positive experience. I would like to apply the model of this collaboration in the region to make sure we can deliver successful research outside of UPH studies and COVID-19 studies.

“We welcome pharmaceutical companies and other research institutions to come to us with their protocols, with their ideas, and we can work to make sure that all the regulatory and ethical approvals are in place.

“We run these studies in collaboration with the sponsors, and recruit people from the community."


What next for the Alliance?

Dr Balendra is enthusiastic about the future of the North West London Clinical Research Alliance.

“There is a real sense among us all that what we can deliver together in North West London is unique and important.”

“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 other disease areas.

The Alliance looks set to expand its relationships with life sciences companies and deliver on more commercial clinical studies, after completing the vaccine studies already being delivered.

Dr Balendra added: “90% of our studies come through direct contact with industry, our academics or our trusts, so we’re committed to spreading the word about what we’re doing in North West London far-and-wide. Commercial trials give patients access to treatments that may not be available through the NHS — often life-saving and life-prolonging treatments — and we feel that what we have built can be hugely valuable for this area of work.

“I’d like to take this opportunity to thank all the staff across the Alliance partners and the whole CRN North West London team for all their extraordinary efforts over the last 18 months. I’m looking forward to what we can achieve together in the future.”


Get in touch

If you’d like to find out more about the innovative work the North West London Clinical Trials Alliance is doing, contact Dr Suki Balendra: suki.balendra@nihr.ac.uk