Tayside Clinical Trials Unit (TCTU) is a collaboration between the University of Dundee and NHS Tayside that seeks to provide support and services to investigators with the aim of improving the success and quality of studies. Senior Clinical Trials manager Dr Sarah Inglis explains more for the One Dundee blog.

What does the TCTU do?

The role of the Tayside Clinical Trials Unit (TCTU), is to provide support and services to investigators with the aim of improving the success and quality of research. We were established in 2008 as a collaboration between the University of Dundee and NHS Tayside, based in TASC, and we’ve been registered with the UKCRC since 2009.

As a trials unit, part of our job is to run clinical trials. However, there is maybe a misconception that we only work on large drug trials based in many sites across the UK and further afield. While that’s obviously a big part of what we do, we also fully support a wide range of research activities, such as non-drug trials, complex intervention studies and observational research.

TCTU provides expertise throughout the lifecycle of a clinical trial, from study design, through regulatory submissions, set-up, trial management, data management, analysis and publication. We can support complete trial oversight and delivery or smaller work packages, tailored to the specific needs of the research team.

We encourage researchers to contact us as early as possible, ideally as they are formulating their research question, as we can provide input to trial design, the participant pathway and budget generation. This pre-award, research design advice on methodology, sample size and peer review is free of charge and we are always happy to discuss a potential research idea. We don’t only offer support to clinicians; anyone who is involved in health sciences research from any School in the University can contact us, including research students.

We have recently redesigned our website so please visit here to see the full range of support we can offer and how to collaborate with us: https://www.dundee.ac.uk/tctu/

What does it take to run a clinical trial?

It takes a large team and a lot of hard work! At TCTU we have a team of senior trial managers, trial managers, data managers, data and trial coordinators, administrators and statisticians, all of whom play an essential role in setting up and running a clinical trial.

Once the funding is in place, a lot of work is required before a trial starts, including the production of trial documentation for regulatory and ethical approval, various agreements, drug supply processes, development of data management and randomisation systems, training site staff and data management plans to name but a few.

Once a trial has started recruiting, our management teams can oversee every aspect of the trial including tracking participant recruitment rates, data entry and quality, changes to the participant pathway, participant safety and troubleshooting a multitude of issues as they arise.

As well as working within the in-house team, we collaborate very closely with chief investigators, the academic group who lead the trial and the research nurses who perform patient visits. We also liaise with TASC research governance who are responsible for ensuring we follow regulatory requirements, and research ethics committees, who protect the wellbeing of research participants. This is in addition to a whole range of third party collaborators on the trial.

Our clinical trial routemap depicts the lifecycle of a typical clinical trial.

How has your work changed since lockdown?

We had to adapt very quickly to the COVID-19 pandemic. When lockdown was announced, the way we managed trial activities and patient visits had to be changed, putting some things on hold. This was completely new to all of us and it took a lot of work to communicate these changes to all the trial sites we work with across the UK and all of the participants who were affected by this. Some trials could continue with amendments to the way they were run to ensure the safety of participants and staff that still allowed researchers to collect useful data.

Switching to home working was definitely a learning curve. We are a very communicative team and we have had to adapt to online trial meetings. It hasn’t been easy, but our team have risen to the challenge in this extremely busy time.

What have you been doing to help the effort to treat Covid-19?

Shortly after we started home working, we were faced with a new challenge of remotely setting up a clinical trial. Not just any clinical trial, but a Covid-19 drug trial. As Covid-19 is a new disease that is affecting a huge number of people with no known treatment, research into this disease is a national priority.

We supported the grant application that Professor James Chalmers was awarded for the STOP-COVID19 clinical trial, funded by the pharmaceutical company INSMED. The usual time frame for setting up a clinical trial is six months-plus. Our team have worked extremely hard to set up this clinical trial in a third of that time.

The STOP-COVID19 trial is the first Scottish-led coronavirus trial and is taking place across 16 hospitals in the UK. It investigates whether a new anti-inflammatory drug, Brensocatib, can reduce the length of hospital stay and the number of patients who require mechanical ventilation. The first patient for this trial was recruited in Tayside at the start of June.

Following this success, we are currently in the process of setting up another of Professor Chalmers’ trials in patients with suspected Covid-19 lung disease – STAR COVID. This trial investigates whether another new drug, SFX-01, can improve symptoms and reduce hospitalisation for patients with suspected Covid-19.

What are the main challenges you have faced?

The main challenges have been adapting to working remotely and moving trials from the design stage to “Go Live” very quickly in order to provide the greatest possible benefit to patients with Covid-19, while ensuing we maintain our usual high standards and participant safety.

Has this changed how you will approach clinical trials in the future?

We have learned that remote working can be very efficient and save time and money. We would normally visit each hospital site collaborating on our trials in person before they start. This can mean extended periods out of the office delivering training and can be difficult to organise given clinical commitments of the teams at sites. However, for the COVID trials we have developed online training, designed in bite-sized chunks so that busy clinical staff can fit this in when they have the opportunity. We then arrange remote meetings to confirm they have completed the mandatory training and answer any questions they might have. This has worked very well and reduced the burden on staff at sites and on us too. We will definitely adopt this as a new way of working going forward.

What other types of projects does the TCTU normally work on?

TCTU have supported and worked on a huge range of different research projects. We have experience and expertise in performing trials in a wide range of disease areas, including respiratory diseases, Hepatitis C, kidney disease, cardiovascular, anaemia, cancer therapy and cancer screening, dentistry and chronic pain. Some of these have been drug trials but others have been trials of behavioural interventions or the best ways of delivering care, such as through community pharmacies or use of social prescribing. We have also worked with lots of different patient populations, including prison studies, paediatric studies, medicines for the elderly and intravenous drug users. Our portfolio is not limited to the UK as we have successfully delivered trials recruiting from across Europe and currently have a study recruiting in Australia.

Our website highlights live studies as well as those we’ve completed, with links to relevant publications. We are always happy to discuss a new research idea and we can provide advice on draft protocols or grant applications.

To discuss your project with TCTU, please email us on TCTU@dundee.ac.uk

Is there a way people can volunteer to help in clinical trials?

Most of the trials TCTU support, recruit through specific clinics or GP referral. We depend on the generosity of patients and their families to participate in clinical research without any personal benefit. We would suggest that patients should explore the possibility of getting involved in health care research with their care providers.

TCTU are also involved in patient and public involvement (PPI) in research, where we believe research should be carried out with people, for people. We are soon going to be inviting patients and members of the public to become part of a PPI panel, which would involve giving input into new trial designs, assessing patient information sheets for clarity and being patient representatives in trial meetings. If you are interested in finding out more about becoming become a PPI representative, please email TCTU.