Guest blog: A radically different way of supporting clinical studies in North West London
Suki Balendra completed her PhD in BioChemistry at the University of Warwick and has held roles in industry, NHS, government and academia for almost 20 years. As the Life Sciences lead at the North West London NIHR Clinical Research Network, she was responsible for setting up the North West London Clinical Trials Alliance, which held its official launch this month. We asked Suki to tell us a bit more about this in this blog…
A radically different way of supporting clinical studies in North West London
Since the start of the COVID-19 pandemic, in North West London we’ve recruited over 80,000 participants into 65 COVID-related studies. This includes over 2,000 participants recruited into 8 vaccine studies. These extraordinary achievements were not just a product of brilliant science (although that was certainly a part of it). They also needed a radically different way of supporting studies.
In North West London, we recognised the urgency we were faced with, and we knew the only way to deliver would be together.
The Alliance this led us to form – the North West London Clinical Trials Alliance – is a collaboration between the clinical research facilities, primary care network and the clinical research network (CRN). We’re dedicated to delivering commercial and non-commercial clinical trials, using both existing and purpose-designed facilities to deliver both early and late phase trials. Our partners are Imperial College Healthcare NHS Trust, Chelsea and Westminster Hospital NHS Foundation Trust, London North West University Healthcare NHS Trust (LNWH) and NIHR CRN North West London, including primary care.
https://player.vimeo.com/video/595872510?badge=0&autopause=0&player_id=0&app_id=58479&h=3dd8957c91
How the Alliance came about
To explain how the Alliance came about, I should explain that, from my background in industry, I have a strong interest in process improvement. It was in a manufacturing environment that I was introduced to the Lean Six Sigma Methodology, and I’ve carried that with me throughout my journey through clinical trials. When I made the move from industry to academia and clinical research, I became more and more passionate about working with life sciences companies, and what we could achieve by working together, across boundaries, sharing information and resources.
When the COVID-19 pandemic emerged, and I became the regional lead for the COVID vaccine portfolio across North West London, we quickly recognised that working in institutional silos would not deliver what was needed.
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 they 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.
Process improvement by centralised support
The opportunity we saw was to take the pressure off study sites by taking some of the processes off their hands, so they could focus on the core work of the study. By pooling resources and using a centralised, flexible team, we were able to offer packages of support to sites. A few of the services we developed included:
- Screening and identifying participants, including the many thousands applying through bepartofresearch.nihr.ac.uk
- 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
- A whole new central out-of-hours service that patients could call
- Support from our strategic workforce – a regional team of nurses and clinical trial practitioners that we’re able to deploy on site.
Setting up this support, much of it from scratch, was challenging of course. During a time where trust workforces were being redeployed to front line work, we were fortunate to be able to repurpose some of existing CRN staff who usually work in the Study Support Service team. 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.
Novavax
The Novavax trial is just one example of how this came to life. Novavax was one of the first commercial COVID vaccine trials in the UK and it was hugely successful. Over 575 participants were recruited to the trial in under five weeks. The trial was run at Chelsea and Westminster, but it was a true regional effort.
https://player.vimeo.com/video/604807517?badge=0&autopause=0&player_id=0&app_id=58479&h=f5e498bb02
Clinicians from Imperial and LNWH 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…
A new era of collaboration in North West London
Fast-forward to our launch event this month for the North West London Clinical Trials Alliance, and it is so encouraging to see the enthusiasm for this type of collaborative effort. We had over 100 people attend our launch event, including 19 different life sciences companies, and 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 develop to tackle COVID and applying it to other disease areas.
In North West London we have a patient population of 2.6 million. We are surrounded by the best academic institutions and NHS Trusts. And very importantly, we are ethnically diverse, with around 50% coming from a BME 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. It’s not to say that there is no diversity in other parts of the country, but 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 feasibilities before even starting a study.
The future of our Alliance
Now that our Alliance is officially launched, we look forward to completing the vaccine studies we’re already delivering, and to building on what we have to expand our relationships with life sciences companies and deliver on more commercial clinical studies. 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’m also delighted to be representing the Alliance as part of MedCity’s Diagnostics Growth Hub, bringing the clinical research perspective to the Hub, and being part of a cohesive group working to support diagnostics companies. That spirit of working together in collaboration and cohesion is something we haven’t seen enough of in the past, but that I hope we will see more of in the future, as exemplified by our work in the North West London Clinical Trial Alliance, and much of the work MedCity does across London.
Finally, I’d like to take this opportunity to thank all the staff across the alliance partners and the whole North West London CRN 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 suki.balendra@nihr.ac.uk