GRADUATE-ing from the pandemic

How one research team managed their trial

Research teams across Royal Brompton and Harefield hospitals (RBHH) have made a great effort to continue conducting research during the COVID-19 pandemic, with many adopting new ways of working to adapt to the restrictions put in place, and to protect the safety of staff and patients.

In this feature, we spoke with the allergy research team at RBHH and Imperial College London, led by Stephen Durham, professor of allergy & respiratory medicine, who, despite the challenges of the pandemic, managed to recruit all the participants required for one of their allergy studies.

The group has an international reputation in allergen immunotherapy for allergic rhinitis, with their work leading to registration of novel treatments for Hayfever in the UK and Europe.

We discussed the challenges they experienced, the strategies they adopted to overcome them and the advice they would give to other research teams.

What is the GRADUATE study about?

The GRADUATE study is a clinical research trial which will test whether a novel drug called Dupixent®, given with Grazax, will help it to work more quickly, and remain effective after the completion of treatment.

Grazax is an established grass pollen immunotherapy for hay fever. Immunotherapy not only reduces symptoms of hay fever but modifies the allergic disease by increasing tolerance to the grass pollen.

Participants were recruited between November 2020 and June 2021 and will be randomised between October 2021 and January 2022. 108 participants will be split into 3 groups and will have either Grazax alone, Grazax with Dupixent® or double-placebo for 2 years. Participants will then be followed up for a third observational year to check for long term effects.

The trial is funded by the Immune Tolerance Network, National Institutes of Health and we expect the full results to be available after the study closes in 2025.

How did the COVID-19 restrictions affect the study?

We had a site initiation visit in February 2020 and were poised and ready to start soon after. But as for everyone, we had to put everything on hold from March and there was a lot of uncertainty.

We felt very lucky that the study was approved to open for recruitment at the hospital in November 2020 and despite it being winter, we were still seeing a marked interest from volunteers suffering from hay fever.

As our study is seasonal in nature, this meant that even with additional distancing, cleaning and reduced footfall measures, we managed to recruit all of our 108 participants in good time for the summer peak hay fever season. In effect the study has been delayed by one year, but our baseline season data, which we thought might be compromised, has been successfully collected.

What measures did you take to help encourage participants to sign up for the study during the pandemic?

We had a very positive response from hay fever sufferers keen to take part in the research, even with continued restrictions and concern. Our volunteers seemed to be reassured with the safety measures taken by RBHH, including the use of personal protective equipment (PPE) and reduced footfall in the hospital, in addition to the extra checks and cleaning.

We were also able to provide taxis for those who felt more comfortable travelling in this way when cases were particularly high.

How many participants did you manage to recruit?

We worked with Absolutely Advertising, a marketing company, and the Sponsor of the study have a website where people could register their interest for the study. The original plan had been to use adverts on the London Underground as our main source of referrals, but it was clear this may not reach a sufficient audience due to reduced transport use during the pandemic. The company adapted their strategy, and we received the majority of our referrals via Instagram, and later through a very popular radio advert. These two methods also complemented each other in terms of demographics, allowing us to reach a wider audience.

We had a huge response – more than 3,870 referrals in total. After many phone calls, where we pre-screened in detail, to reduce wasted journeys and footfall in the hospital, we managed to screen 180 participants, and identify 108 individuals suitable to proceed to randomisation in the study, which was our target figure.

What kind of feedback have your participants given you when they come in for their visits?

Participants have been great at working with us to minimise Covid-19 risks, returning questionnaires on time and wearing the requested personal protective equipment (PPE). They were reassured by the efforts made, and our ability to be clear about the requirements and answer any questions.

All the participants have been pleased to be able to get involved and are looking forward to their future visits at the clinical research facility.

One participant said: “In a strange way it’s always nice visiting the hospital for the trial sessions. The research team are friendly, professional and thorough, and they are very patient with me even when I forget important things - and there’s an app they’ve developed to remind me to submit my weekly symptoms. I’m happy to be helping out.”

How did the pandemic affect your team and how they worked together?

As with all teams, we had a period of uncertainty in 2020 and had to adapt to meeting and keeping up with each other in new ways, often not seeing each other in person for months. We also had to build relationships and get to know our colleagues in the clinical research facility, pharmacy and laboratory over emails rather than in person– but we have managed to feel very valued and a part of the teams.

The clinicians in the team have had to adapt their clinics and take on other priorities at times, but it was great to be able to start the research in earnest and have our volunteers come in for visits from November.

What tips would you give your colleagues who might be struggling to recruit for their research studies?

There is a lot more awareness about medical research, and people keen to give their time; it’s just a case of finding them. Certainly we needed to adapt from traditional recruitment methods and be open to new ways of reaching out to volunteers, especially now that people are spending their time differently and finding information in new ways.

We had a huge response to social media advertising for a mainly younger age group and have found that more people are now listening to the radio while working at home in the 30+ age groups.

We have also had to consider things from the patient perspective, what they might be worrying about or prioritising at this time and being really clear in communicating what to expect. We’ve been able to be very clear and consistent in our messaging thanks to the clear protocols that have been laid out by RBHH.

Our volunteers are in a lower-risk group for Covid-19, but this may not be true for all studies. Being clear about safety measures, and demonstrating that you are taking these seriously, and being supported by the hospital to do so, is really important.


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