How it started
In May 1747 surgeon mate James Lind, aboard the HMS Salisbury, set out to test if his hunch about how to treat scurvy, which was rife among seamen and causing a devastating loss of life, was right.
Based on his idea that scurvy was caused by putrefaction of the body that could be cured through the introduction of acids, he recruited 12 sailors and allocated two men to each of six different daily treatments: cider; elixir vitriol (dilute sulphuric acid); vinegar; sea water; oranges and lemons; and a medicinal paste made up of garlic, mustard seed, dried radish root and gum myrrh. Those allocated the fruits experienced "the most sudden and good visible effects."
It was the first randomised clinical trial and the method has endured to this day to test the effects of drugs, treatments, and interventions in patients. So, May 20th now offers an opportunity to reflect on, and applaud recent achievements and the teams of people who have made these trials possible.
Expanding our capabilities
Clinical trials are at the forefront of research at NDORMS where clinical trial design and delivery is one of our key academic objectives. As a department NDORMS houses the Oxford Clinical Trials Research Unit (OCTRU), which is a fully registered CTU (Clinical Trials Unit) and leads and co-ordinates strategy, operations, and systems across a range of therapeutic areas. Many of the NDORMS studies are jointly co-ordinated through the Surgical Intervention Trials Unit (SITU), the Oxford Centre for Clinical Therapeutics, the Oxford Trauma team or the Centre for Rehabilitation Research in Oxford (RRIO).
In recent years NDORMS has seen initiatives that streamline the process of developing new medicines and medical devices which have a meaningful impact to patients.
This was seen most recently when Oxford was named as one of 28 sites benefitting from a £160M funding boost from the NIHR (National Institute for Health and Care Research) to establish the new NIHR Oxford Clinical Research Facility (Oxford CRF). The Oxford Experimental Medicine Clinical Research Facility, which opened during lockdown, will act as the hub of the Oxford CRF and provide a resource for early phase, experimental research. Since opening its doors it has mainly focused on supporting Covid-19 trials, but is now moving to launch new challenge studies in vaccines, oncology, gastroenterology, and immune mediated inflammatory diseases, supporting studies across the University's Medical Sciences Division.
Refocusing during the pandemic
While Covid-19 may have slowed the progress of some clinical trials, it has shown the critical role that they play in assessing how and if drugs work. The OCTRU team rose to the challenges presented by the pandemic, jumping into action to respond at speed to new trials. Vicki Barber, Anne Francis, Lucy Cureton, and Lucy Eldridge have all been part of the VROOM trial, which has been accepted for publication in a leading medical journal, and tests whether temporarily suspending methotrexate treatment for two weeks enhances the Covid-19 vaccine response. OCTRU was also involved in the Catalyst trial.
All our nurses, recently celebrated on International Nurses Day, redeployed to Covid-19 vaccine trials during the pandemic, and are critical in providing care in our trials across our themes.
A new approach
Traditionally, trials have tested one drug for one disease, generally against a placebo. But a new type of trial is emerging. A-TAP (the Arthritis Therapy Acceleration Programme) is looking at the underlying cellular basis of inflammatory diseases. These trials look at how drugs affect the cells in tissues so they can be used to study how one drug might work across a range of different diseases. The group is developing what are called basket trials to accelerate the process of bringing basic science discoveries into the clinic to treat patients.
Of course, no trials would be possible without patient volunteers. The department's connection within the Oxford University Hospital Trust provides a willing pool of volunteers across disease areas. But as with many trials across the country, access to a wider range of volunteers from different ancestries are needed. Work is under way in OCTRU to encourage diversity of participation in early phase clinical research as part of the Open Arms project. The team is reaching out to underrepresented communities to understand barriers to getting involved, identify strategies to enhance participation, and ensure they are included in research to provide the greatest possible benefit to the community.
I'd like to say a huge thank you to everyone at NDORMS for the part they play in delivering this important area of our research programme. Further expanding our capabilities in clinical trial design and delivery is one of our key academic objectives. From researchers, clinicians, nurses, statisticians, patient volunteers, to funders and the wider public; without your efforts, collaboration and perseverance we wouldn't be able to succeed and take new discoveries from bench to bedside and improve patients' lives.
Professor Jonathan Rees, Head of Department, NDORMS