Thursday 20th May is International Clinical Trials Day, a day to celebrate research and the vital trials that mean new treatments can be safely brought to patients.
Due to the pandemic, the past year has proved extremely challenging for everyone involved in health care and research, and the Southampton Clinical Trials Unit has been no exception with our staff having to adapt to unprecedented times to make sure our vital work can continue.
I am incredibly proud of everyone at SCTU and what we have been able to achieve. Not only have we quickly set up ground-breaking trials to test potential COVID-19 treatments, but we have worked tirelessly to keep our other trials running as smoothly as possible.
We have been speaking to some of the staff in different teams across the unit to give you a greater understanding of the work they do and how they have been able to adapt to these difficult circumstances.
Gareth Griffiths, Director of the Southampton Clinical Trials Unit
I’m the trial manager on the SAFA study, trialling a new treatment for female adult acne. This means I am the main contact for the trial site staff, and work with the data manager and statisticians.
I love the variety of tasks I have as a Trial Manager, like the day-to-day queries from trial sites, preparing reports for the different trial committees, or creating and updating the trial website. I’m also responsible for making the necessary changes if certain aspects of the trial require adaptation, and this part of my role became particularly important because of the COVID-19 pandemic.
When recruitment into non-COVID-19 studies was paused at the beginning of the pandemic, we had to think about the changes we needed to make to the trial design and processes in order to be able to continue recruitment. This included a reduction of face-to-face trial visits, remote follow-up visits, and posting study medication and questionnaires to participants. We also decided to utilise social media advertising to identify eligible women interested in taking part in the trial. By running the adverts in house, we were able to control the design, and determine the geographical areas and the timing of the adverts. The campaign has been hugely successful and social media advertising is now our main way of identifying patients for the study with ~60% of women contacting us being recruited into the trial.
I feel the past year has put a spotlight on clinical trials and more people are now aware of clinical trials. And even thought I wasn’t directly involved in any of the COVID-19 trials, I feel proud of what we as a CTU have achieved over the past year.
As a statistician, I spend my time doing a wide range of things from writing programmes in statistical software, to carrying out analyses for trials, and doing sample size calculations to work out the number of patients needed for a trial. We’re always very busy!
We work on several trials at a time, each usually at different stages. At the moment, I am mainly working on CONFIRM, a lung cancer trial in the final analysis stage, and SoMOSA which is an asthma study where the data are being anonymised ready for external data sharing.
Liaising with the other teams in the CTU is important in ensuring that deadlines are met. The data team do an amazing job in making sure that the data are as complete and clean as possible to make our job performing analyses run smoothly. Within the CTU it’s so easy to ask questions if there is something you are unsure of, lots of us come from different backgrounds so there’s always chances to learn new things from colleagues. And we also have a laugh which has most definitely helped me through some tough days. Working with likeminded people who are super-supportive is great.
By working in a CTU you can see how the work we do will provide so much benefit to patients, and this is a massive motivation for me and makes me proud to do my job. There are always opportunities to share your achievements with others which is very rewarding.
I am currently working on the ELEVATE trial which will test the efficacy of combining two immunotherapies for treating patients with advanced, previously treated oesophagogastric cancer.
The primary reason for doing any study is to collect data to help advance our understanding of diseases and inform better patient care and treatment. The data team help collect and manage that all-important data as well as make sure it is organised and accurate to allow the stats team to analyse it, and we provide trial management with reports on how trials are going.
Designing and building databases that not only capture the data but also automatically checks for errors and automatically calculate other fields can be very complicated, but the more challenging something like that is, the more I enjoy it!
It’s really important that clinical trials are run well so that the data and results can be trusted and accepted, and patients can more quickly benefit from what was learnt. But running a clinical trial is a massive and challenging endeavour. Clinical trials units like the SCTU provide the experience, expertise and organisation needed to run top-quality and impactful clinical trials and so I am very proud to be part of the team delivering this. However, I started my current role within the SCTU in the middle of the COVID-19 pandemic with everyone working remotely, but hopefully I will get to actually meet all my colleagues in-person soon!
Research hasn’t always been a field which everyone has been aware of, but over the last year it has made headlines and put the whole community under the spotlight. Organisations, scientists, trial units and many more have come together to find the best global solutions for this unprecedented situation. The results have been remarkable and have shown just how valuable research is in supporting the health and wellbeing of every individual.
I work in the lymphoma portfolio of our oncology group and am currently working on three phase II trials. These trials combined an already used chemotherapy with a new drug in the hope that it would improve the outcome for the patients. I will start working on a new trial next month which is a Phase III trial for patients with high grade lymphoma who have progressed or relapsed since their first treatment.
Each trial has between six and ten team members who are each expert in their field and bring a different set of skills and perspective. I am responsible for the project management of trials, supporting a team of Trial Managers who deal with the day-to-day trial activities, and overseeing the trial timelines and budget. We are responsible for ensuring the trials are conducted in line with Good Clinical Practise and other regulations. We lead the conversations in our regular meetings with the trial team to ensure we reach conclusions and keep the trial moving forwards.
My favourite thing about my job is the diversity in what I do on a day to day basis, it is the opposite of monotonous. I get to work with a fantastic group of people to conduct exciting and cutting-edge research. The daily challenges are similar to any project management role, but they are worth it as we are working to improve the lives of patients and find new and better treatment options.
During the COVID-19 pandemic, we had to alter the way we conduct our research at the NHS sites to protect not just the vulnerable patient population but also the hospitals’ capacity and resource. Reacting to the pandemic was operationally very challenging as we needed to amend our protocols and processes, and we had to adapt to working from home for the first time. The SCTU as a whole has done this fantastically and I think we should be proud that we have continued to deliver research to the best of our abilities during this difficult time.
The Quality Team ensures that the CTU meets the appropriate regulatory requirements for conducting research and continually evaluates and improves our practices to make sure we are delivering the highest quality research.
The full life cycle of a trial is a collaborative approach between all of the CTU Teams. Trial, Data and Statistics Management Groups use their skills and expertise to provide input into the study design and deliverability, and we provide quality control of the documents produced and support the risk management and quality reporting of the specified activities.
I really enjoy the fact that being part of the quality team I get to work on all of the projects the unit is running and see how the research we are co-ordinating varies across such a huge range of areas.
I started working at the CTU during lockdown, so it has been a strange experience getting to know a new team and job role over video calls. I am looking forward to the day when I can meet the team in person and spend time in the office which I have yet to visit.
I think marking International Clinical Trials Day is a great way to show support for all the research being conducted around the world and celebrate its achievements. Research hasn’t always been a field which everyone has been aware of, but over the last year it has made headlines and put the whole community under the spotlight. Organisations, scientists, trial units and many more have come together to find the best global solutions for this unprecedented situation. The results have been remarkable and have shown just how valuable research is in supporting the health and wellbeing of every individual.