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Recruitment success puts spotlight on what we can do better

Our data-driven clinical trials service, NHS DigiTrials, is changing what is possible for researchers but there’s more to do, says our Head of Clinical Trials.

We’re seeing numbers coming out of the NHS DigiTrials’ recruitment service that would not have seemed possible 2 years ago.

Crowd of people walking on London street

Last week, Our Future Health, the UK’s largest ever health research programme, announced that it had signed up its millionth participant, a year after launch.

The NHS-Galleri trial recently published its first analysis of recruitment (opens in PDF) across a range of ages, socioeconomic groups and ethnic groups. That trial reported the fastest ever recruitment to a large-scale randomised trial last year: 140,000 people in 10 months.

NHS DigiTrials has been far and away the most important channel for recruitment for Our Future Health

The new capabilities making this possible are really exciting.

The system we developed for Our Future Health, for example, can not only send out up to 100,000 invites a day to potential recruits but also allows the researchers to review participation in real time and change their approach dynamically to ensure representation across different parts of the population.

NHS DigiTrials has been far and away the most important channel for recruitment for Our Future Health, accounting for at least 770,000 (77%) of participants.

Improving representation

But the heart of any benefit offered by a clinical research recruitment service must be improving the quality of recruitment, and this is where we are starting to see NHS DigiTrials really come into its own. As we embark on the second phase of pilots, we have taken the opportunity to assess and evaluate what we’ve learnt from our first pilots. 

It is well documented that older, ethnically diverse and socio-economically deprived people are often under-represented in clinical trials.  This lack of diversity has significant impacts because the results cannot then be generalised to the wider population and that means we might miss important information about benefits and risks.  In turn, this does not allow patients to make the right decisions about their own health and care based on robust information about the side effects and efficacy of treatments for them as individuals. 

It was not successful in boosting numbers from ethnic minorities

Our direct-to-patient recruitment mechanism starts with the whole population in England and allows us to invite those that may be excluded by traditional recruitment methods such as trying to reach potential participants through their clinicians.

This, coupled with novel approaches like running trials from mobile or community locations or completely virtual trials that do not require any travel, has the potential to shift the dial in this area.

The recent analysis of NHS-Galleri trial (opens in PDF) showed that the NHS DigiTrials recruitment method was successful in achieving representation of more deprived and older age groups, as well as providing a balance between male and female participants.  However, it was not successful in boosting numbers from ethnic minorities. 

This analysis has given us some important food for thought, though; particularly around the very different uptake rates for different groups.  One useful measure of this is our “number needed to invite” (NNI) figure: the number of invitations that needed to be sent to achieve one person enrolled into a study. 

Overall, for NHS-Galleri DigiTrials recruits, the NNI was 10.6 (1,477,051 invited/ 139,617 enrolled). This was better than previous studies, but the NNI varied widely between groups:

  • 14.8 invites per recruit for 50 to 54-year-olds compared to 10.7 for those aged 75 to 77
  • 32.8 for Black and 28.2 for Asian participants compared with 9.7 for White  participants and 8.1 for people from mixed backgrounds
  • 21.5 for people from deprived backgrounds compared with 4.6 for the least deprived
  • 11.1 for men and 10 for women

How do we improve?

The figures for Black and Asian participants are stark.  Part of the reason that the NHS DigiTrials recruitment approach was not effective in achieving an ethnically diverse population is that comprehensive data is not held centrally by NHS England.  Better ethnicity data availability could enable better invitation targeting and help us improve in this area, but this is a very sensitive area that needs careful consideration.

It is clear that there are wider barriers to participation in research, including mistrust in clinical trials and the healthcare system, the need to travel or take time off work, language barriers and perceived low personal relevance.  More work is needed to look at how to best address these challenges. 

The early successes of NHS DigiTrials, while encouraging, are also putting a brighter spotlight on our current limitations. Being able to start with the whole population and offer opportunities to participate takes us forward, but it is by no means the whole solution.    

These problems are complex and multifaceted and collaboration with research partners and communities is going to be the key. In approaching this work, one of our most important assets will continue to be our patient and public co-development panel, a group of incredibly committed people from different backgrounds and ages that helps us design and develop the service and improve the way we communicate with people.

Sadly, we recently lost one of our panel members, Dolapo Ogunleye. I think the blog post she wrote last May sums up some of the challenges we need to address.  As we continue to develop our service, Dolapo’s influence and legacy will continue as we strive to continue to find ways to widen opportunities to participate in research, improve diversity and ensure clinical research works for everyone. 

Related subjects

Dolapo Ogunleye, a member of the patient and public co-development panel for NHS DigiTrials, says technology is improving clinical trials but we need to reach out to all communities to ensure the benefits are equally shared.
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.
On International Clinical Trials Day, James Gray, NHS DigiTrials Service Delivery Manager, talks about the new Feasibility Self-Service tool that drastically cuts the time it takes researchers to find out if there are enough potential participants for their clinical trial.


Last edited: 16 November 2023 12:47 pm