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Creative solutions keep Cystic Fibrosis research trial running during the COVID-19 pandemic

Creative solutions keep Cystic Fibrosis research trial running during the COVID-19 pandemic

‘No one ever said they couldn’t do it’ says Sophie Whiteley, CTAP Cystic Fibrosis Trials Coordinator at the Royal Devon and Exeter Foundation Trust, as she describes the attitude of colleagues and patients as they faced up to the challenges of delivering a study in the early stages of COVID-19 pandemic.

The team at Royal Devon and Exeter is one of 17 sites across the UK delivering the Cystic Fibrosis (CF) study for patients aged 12 years and older. The study runs for 24 weeks and compares two drugs that weren’t previously available on the NHS; Symkevi (dual medication) and Symkevi + Elexacaftor (triple therapy).

The study team quickly devised new ways of working so that treatment continued for the adults and adolescents involved. They even managed to enrol them into the follow up open-label trial whilst in lockdown.

Dr. Nick Withers DM FRCP, Consultant CF/Respiratory Medicine at the Royal Devon and Exeter NHS Foundation Trust and Principal Investigator on the study, said: “During the COVID-19 crisis, the Research Team have worked flexibly and have adapted to ensure patients could continue in these crucial trails. They are very grateful to the patients for their flexibility and understanding to allow this to work.”

As research teams across the country faced up to delivering studies in rapidly changing circumstances, how the study was delivered also needed to adapt to ensure that patients still had access to studies. The first step was for the sponsor, Vertex, to swiftly amend the study protocol to ensure continued drug supply at a worrying time for patients. As Sophie describes:

‘We didn’t want them to have an interruption in their treatment. The patients are ‘at risk’ group and were shielding at the time; due to problems with their lungs they are prone to frequent infections. Patients were worried and didn’t want to come to the hospital, it’s a hard situation to put themselves at risk.”

Early on Vertex stated that patient safety was their top priority. Once the first amendment to the protocol was made the study drug could be dispensed at the hospital’s pharmacy and shipped to the patient's home by courier. This meant patients could continue to access the drug as part of the trial but without needing to visit the hospital in person.

“We’ve known and worked with many of the patients for a long time” says Sophie: “The Cystic Fibrosis Team have worked with the participants for years. Patients in the study take a drug twice a day and there are study visits on average every four weeks. Study visits changed to more home visits and video calls with the study team. We knew we had to change and start offering remote visits  so we started with a call to check they were okay and we followed this up by sending a questionnaire to their home.”

As the world adjusted to remote working so did the study. Vertex sent the participants a home testing Spirometer kit and a small mobile phone to conduct home testing for four months and send the results into the Research Team. The next big challenge was consenting patients to the new follow up study. Vertex secured ethical approval to ensure participants could take part remotely. This included remote consenting, for example over the phone. All the patients involved in the initial study consented to take part in the new one.

Rebecca Brendell, Head of Clinical Trials Accelerator Platform at the Cystic Fibrosis Trust, said: “The CF team at Exeter provide their patients with valuable opportunities to participate in clinical trials. Participation in trials is an important chance for members of the CF community to not only contribute to the development of new therapies for CF, but they also present unique opportunities to gain access to potentially life-changing therapies before they become available on the NHS. 

“During the height of the COVID-19 pandemic the majority of CF trials were temporarily suspended. However a small number of CF trials remained open thanks to the flexibility of Vertex and the willingness of a number of CF centres around the UK, including the CF centre at Exeter. Thanks to the local clinical and research team, trial participants enrolled onto the Vertex trials were able to remain in the trial and continue to receive the trial medication throughout the pandemic. Sophie and the team were instrumental in ensuring the trial participants were happy to remain in the trial in addition to providing them reassurance that their health would continue to be closely monitored from their home throughout the time they were shielding whilst taking part in the trial. Thanks to the team at Exeter participants enrolled onto these important trials were able to keep taking the trial medication and therefore continue to experience the health benefits associated with taking these transformative therapies.”

The Cystic Fibrosis Trust, Clinical Trial Accelerator Platform (CTAP) is an important national network, members contacted each other for support because cystic fibrosis studies are often complex and resource heavy. Sophie was speaking to colleagues from across the UK including in Belfast, Cardiff, Glasgow, London and Manchester sharing ideas and practical solutions. Throughout this process, they were learning what was important in a trial. Sophie hopes these learning opportunities will go on to inform more patient focussed trial designs that allow for more home testing.

Sophie added: “The patients were pleased we could put things in place to continue the study, they were really flexible and open to change. They now have home monitoring equipment which means they can monitor their health and give them an early warning that they could be getting ill. The trials rely on patients as experts with lived experience of the condition. This new way of working could change future trial designs. As we build confidence in home monitoring we can reduce the pressure on the patient to travel for face to face appointments. The trial can fit around people’s lives and be less intrusive so they can continue everyday life without interruptions.”

Everyone involved in either delivering or participating in the trial showed a flexible ‘can do’ attitude to ensure that the research could continue in the most challenging of times. This includes the RD+E clinical trials Pharmacy that kept dispensing medicine, the Research +Development Department (both adult and paediatric delivery teams) for supporting the continuation of the study, everyone in the clinical team, the CTAP Network, and Vertex.

Sophie reflects on the collective effort that kept research as a care option for those involved: “The triple therapy [available on the study] is life changing. It’s hard to say what would’ve happened if we didn’t continue with this study but we weren’t going to let that happen.”

For guidance on restarting paused research studies read the NIHR Restart Framework.

 

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