What is your role for the RECOVERY Trial?
I am one of a core team of six responsible for carrying out all the day-to-day administrative tasks required to support the roughly 200 sites taking part in the trial around the world. As you can imagine, this involves a wide range of jobs. Some of the main ones include reviewing and resolving data queries, chasing up missing samples, and checking that the relevant staff at each study site have completed all the necessary training to participate in the trial.
What do you do on a day-to-day basis?
Every morning the first thing I do is log on to our central email account and check the queries and requests in the inbox. Many of these are from the hospital sites involved in the trial. Since hospitals never close, these come in at all hours of the day and night. My colleagues and I each manage a specific group of hospitals, so we start by assigning every email to the right person in the team. There is often a lot of overlap between the requests. For instance, when we add a new treatment arm to the study, many of the hospital sites will ask similar questions on how to administer the drug, where it will be supplied from, etc. During our regular team meetings, we discuss questions that have arisen, particularly any recurring issues, and receive key updates from RECOVERY’s senior management team.
RECOVERY draws on data from multiple sources, so a core part of our role is making sure these align correctly and addressing any inconsistencies. For instance, differences in a participant’s recorded date of birth. We also deal with IT issues, and set up new accounts and passwords so that the site staff can securely access the trial database. We are not medically trained, so we send any clinical enquiries to the clinical team.
We can typically receive several hundred email requests and data queries every day, although this was higher during the peak times of the pandemic, so an important skill is to able to prioritise and identify the more urgent enquiries. Any issues relating to a participant’s safety, for instance, need to be seen by a clinician straight away.
The one constant thing is that we never know quite what to expect, and I’ve been involved in a variety of other tasks throughout the course of the trial. For instance, when RECOVERY first launched, I helped to develop the training videos for the study sites, and also worked with an animation company to produce two films explaining the trial; one for potential participants and the other for site staff.
How has RECOVERY been different to other clinical trials?
The speed and urgency at which RECOVERY was launched certainly sets it apart from other clinical trials I have worked on.
At the beginning, it was particularly frenetic, and we were bombarded with hundreds of emails a day. Despite often working flat out into the evening, the list of queries would still be longer by the end of the day. Thankfully, it is at a much more manageable level now!
At the same time, we had the dual challenges of rapidly adjusting to being part of a new team while working remotely. Our group is drawn from various groups and departments across the University of Oxford, including the Clinical Trial Service Unit and Epidemiological Studies Unit and the National Perinatal Epidemiology Unit in Oxford Population Health, and the Nuffield Department of Medicine. Most of us don’t have a home office, so we worked on desks in bedrooms and living rooms, or on the dining room table, but everyone just threw themselves into it. We all recognised RECOVERY’s importance, and the urgent need to find effective treatments for COVID-19. Everyone pulled together to make it happen.
What was your route into clinical trial management?
I don’t come from a background in health research. After doing my GCSEs, I completed a business studies course, followed by a BTEC and then a HNC in building construction. I worked for an office equipment company for 15 years, working my way up from a junior member to general manager with responsibility for running all the company’s departments.
When the company’s owners decided to close the business in 2009, I thought it was time for a change and came to work for Oxford Population Health as an administrator for the SHARP trial, a clinical trial investigating heart and renal protection. I found that the skills involved in running a company were highly transferable to trial management. Since then, I have worked on various clinical trials led by Oxford Population Health, including REVEAL, ORION-4 and EMPA-KIDNEY.
What are the highlights from working on the RECOVERY Trial?
The discovery in June 2020 that dexamethasone, an inexpensive steroid pill, reduced deaths by up to a third in the sickest COVID-19 patients was obviously a big highlight.
The dexamethasone result changed practice overnight and had a huge impact; not only for the UK but also internationally and has led to many lives being saved. Working on a trial that has had such an immediate and important impact is incredibly special.
Another big highlight for me has been working with the whole RECOVERY team: the collaboration between colleagues in the University of Oxford and the teams ‘on the front line’ at the hospital sites has been incredible. It really shows what can be achieved when everyone works together and pulls in the same direction through all the uncertainty, and when we are all driving towards the same goal. Teamwork is a word I will always associate with RECOVERY!