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We’re transforming clinical trial recruitment

Andy Rees, Clinical Trials Operations Manager for NHS DigiTrials, explains how routine NHS data has supported the fastest ever recruitment to a large-scale randomised trial - and explores what the new service means for clinical research in the UK.

When we were approached 10 months ago to help recruit 140,000 people from across the UK population for the world’s largest trial of a new blood test for 50 types of cancer, it felt like a steep ask.

The NHS DigiTrials team had already made a mark during the pandemic with our support for vital COVID-19 research, but our recruitment service was still very much in its infancy.

Gloved hand holding a microtube in front of a computer screen showing Galleri trial data

We were really only at the service design stage, but the NHS-Galleri trial sent a shot of adrenaline into our development.

The NHS-Galleri researchers needed people aged 50 to 77 who had not been diagnosed with, or treated for, cancer in the past 3 years. We also needed to invite volunteers whose ethnicity, locality, gender and socio-economic circumstances aligned with the risk factors associated with developing cancer.

Data-led recruitment

We worked with colleagues in the National Disease Registration Service (NDRS) to identify the most relevant data sets.

GP data wasn’t a route we could use to find people more at risk of developing cancer (for example, smokers), because the GP Data for Planning and Research (GPDPR) data collection was paused. We could, however, make full use of the deprivation index to recruit in areas with poorer health outcomes.

Simultaneously, we were working alongside partners from the Health Research Authority (HRA) and the Confidentiality Advisory Group (CAG) to obtain Section 251 approval to legally access the data we needed. We knew we had to use patient information safely and securely.

This streamlined approach eases the pressure on frontline staff.

We sent letters directly to eligible participants to see if they wanted to take part in the trial. This meant that no patient data left NHS Digital or was shared with the trial organisation. Anyone who had taken a National Data Opt-Out did not receive an invitation.

If the eligible participant wanted to take part, they signed up with the trial directly, and were then asked to provide further information about themselves.

This streamlined approach eases the pressure on frontline staff. Until now, trials have heavily relied on the support of primary and secondary care professionals, requiring them to spend time identifying and enrolling potential trial participants.

Instead, we are using routinely collected, national NHS data sets to identify the right people and taking the burden of contacting people off the local staff.

Faster and more accurate

By May 2022, we’d already found more than 100,000 suitable people who were willing to attend one of the mobile testing sites at 8 locations across the UK.

At this stage, we had learned a lot about making our recruitment methods flexible and adaptable, based on where the testing vans were located and how many participants were needed and that helped us keep up the momentum.

Thanks to the dedication of the recruitment service team, and our great working relationship with our partners, we reached 140,000 people in July 2022 - just over 10 months after we started.

We can work with researchers who are looking for a needle in a haystack.

Our recruitment methods achieved a 12% success rate, compared to the industry standard of 5% (based on this type of trial). We reached out to over one million people and 140,000 of them agreed to participate in NHS-Galleri.

Now that NHS-Galleri is fully recruited, the next stage of support is for our communication and outcomes services to assist the trial with keeping participants informed of progress, follow-up appointments and with analysing trial findings. We’ll be continuing to support the researchers with their end-to-end data requirements. This includes using our communication service to keep participants, who have consented to receive information, updated about the progress of the trial.

Transforming trials

I believe the recruitment service is going to be a jewel in the crown of NHS DigiTrials. We are in a unique position not only to support large-scale and fast recruitment into trials, but to do that with a precision that has not been possible before.

We can work with researchers who are looking for a needle in a haystack – very specific characteristics in a large population—and we can be the engine room for those sorts of trials.

One aspect of that is looking across the population and achieving much more diverse and representative trial recruitment than has ever been achieved through traditional methods. That is a crucial aspect of our next big project. We are working with Our Future Health, the UK’s largest ever health research programme, to secure 175,000 volunteers from all backgrounds to provide information about their health and lifestyles with the aim of building a really comprehensive understanding of what makes people more likely to develop diseases.

We were getting feedback all the time on what worked and what did not.

Looking back on NHS-Galleri, getting our teeth into such a big project right from the design stage of the recruitment service really helped speed everything up. We are in a far better position that we would have been. We had to push ourselves, but working with the NHS-Galleri team meant we needed to think big and that we were getting feedback all the time on what worked and what did not.

We are getting a lot of contacts now and we want to prove over the next 6 months that NHS-Galleri was not a one hit wonder and that this is going to work as business as usual.

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Last edited: 10 October 2022 11:05 am