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The coronavirus pandemic has highlighted the need for high-quality, large-scale clinical trials to provide rapid and robust evidence of effective treatments and vaccines against Covid-19. To contribute to this global effort, our trials unit staff have led the national priority PRINCIPLE trial of at-home treatments for Covid-19, which has recruited nearly 5,000 participants from around the UK. The trial has been the largest of its kind globally in community care, pioneering new research methods, and in April 2021 identified budesonide as the first widely available, inexpensive drug to shorten recovery times in COVID-19 patients aged over 50 in the community. These findings have rapidly informed clinical practice in the UK and internationally, with inhaled budesonide now available for UK GPs to prescribe on a case-by-case basis to treat Covid-19.
For those who took part in the trial, 82% who were surveyed in the Thames Valley said this was the first study they had taken part in, and 96% said they would take part in research again.
While COVID-19 trials have been in the spotlight over the past few months, studies for other health conditions like diabetes, insomnia and microbial resistance have had to adapt and find ways to continue in often challenging circumstances.
The SuMMiT-D trial was set-up during two COVID-19 lockdowns, and while there were some inevitable delays, the time was used to train GP practices and prepare them for opening to recruitment. The trial team had a target to recruit the 958-participant cohort in 12 months, opening for recruitment in mid-March 2021. They recruited over 400 participants (42%) in the first 8 weeks, thanks to a great team effort in supporting practices to mail out and conducting screening calls with patients.
“The last year has been both extremely tough and amazing for colleagues in PC CTU,” says CTU Operational Director Dr Emma Ogburn. “I’m really proud of what we have achieved in amending pre-Covid trials to ensure they continue and also in creating Covid trials, utilising novel methods – all centred on improving patient quality of life, safely and giving hope.”
Oxford’s primary care trials would not be possible without the support and dedication of general practitioners right across the country. GPs are integral to many of the department’s studies, recruiting trial participants from within their communities and helping to inform the design and conduct of trials.
Dr Nick Thomas, from the Windrush Medical Centre in Oxford, said: “Helping to deliver clinical trials is both a pleasure and a privilege. Particularly at this time being able to support key trials that have direct benefit to my patients and the world is something that I will be proud of for the rest of my career.”