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NIHR Patient Recruitment Centre spearheads UK recruitment for multi-site Respiratory Syncytial Virus (RSV) study

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NIHR Patient Recruitment Centre: Exeter is currently the UK’s top recruiting site for a large-scale, multi-site study investigating a new treatment which may help protect babies from serious illness due to RSV infection (respiratory syncytial virus).

RSV often causes only mild illnesses, like a cold. However, for some babies, it leads to more severe lung problems such as bronchiolitis and pneumonia. The HARMONIE Study is a collaboration between Sanofi and AstraZeneca and is evaluating the efficacy of nirsevimab - a preventative solution comprising a monoclonal antibody immunisation that is targeted specifically to fight RSV.

As many as 28,860 babies in the UK, France, and Germany will take part in the HARMONIE Study with 9,620 of those being enrolled across the UK. PRC: Exeter is one of 72 sites in the UK and has already exceeded its recruitment target of 65 and recruited 79 participants to the study, despite the study being open to recruitment until March 2023.

While PRC: Exeter has not delivered a paediatric immunisation trial previously, they have a wealth of experience within their paediatric team who they have cross collaborated with for this trial. The resulting recruitment success demonstrates this specialist site’s ability to rapidly respond and deliver commercial research across a variety of therapies.

Helen Quinn, Clinical Director, at PRC: Exeter said:

“We are extremely proud to have contributed to this important study, along with the other PRCs. Together we are successfully meeting our aim of delivering large-scale, late-phase commercial studies and here in Exeter we currently have 12 studies underway and 10 in the pipeline. This success is a result of how incredibly hard our teams work across each of our PRCs, using our shared operating model and the innovative recruitment strategies that we adopt, which include promoting our studies via our social media platforms and website, and broadcasting on local news networks.”

The study will last approximately 12 months and includes a single in-person visit to the clinic, with all follow up visits being conducted entirely virtually via an app. This virtual approach supports efficient study delivery and helps to make the study as accessible as possible for participants. By minimising face-to-face appointments this approach reduces barriers to participation such as geographical location and the difficulties associated with juggling working hours and caring responsibilities, which affects many working families. Staff at PRC: Exeter certainly feel that the patient-friendly design of the trial has encouraged rapid uptake by participants.

Two other Patient Recruitment Centres are also contributing to the HARMONIE study which is also taking place at PRC: Bradford and PRC: Leicester. All three sites are implementing the virtual elements of the study and are keen advocates supporting this and other innovations in trial delivery.

Hear from a participant at PRC Bradford on her experience of taking part in the trial at PRC:

The PRCs are 100% dedicated to delivering commercial research. They are purpose-designed to increase the UK’s capacity to deliver large scale, late-phase commercial clinical trials and to make it quicker and easier to deliver commercial research in our NHS.

For more information on the study: https://rsvharmoniestudy.com/en-gb 
For more information on the expertise across the PRCs: https://local.nihr.ac.uk/prc/