Trial Management Unit celebrates 10 years of groundbreaking research

It started in 2015 with a study testing a new diagnostic device for strokes. More than 8,000 participants later, the Trial Management Unit (TMU) at University Hospitals Coventry and Warwickshire (UHCW) NHS Trust has celebrated its 10^th anniversary.

Based within the Research and Development department, the TMU provides support with setting up and running trials including obtaining regulatory approvals, feasibility assessments, monitoring recruitment and data management.

The last decade has seen a wide variety of research projects, including:

• PHOENIX study looking at the impact of providing personalised physical rehabilitation and nutrition plans on the ward after leaving Critical Care
• eXcision study using a scanner known as Aura-10 to check whether all the cancer has been removed from patients while they are still on the operating table
• FREEDOM trial looking into whether a new product could improve the absorption of the hormone progesterone in threatened miscarriages
• SHiP-Rt study to investigate whether shorter radiotherapy treatments improved the quality of life for terminally ill lung cancer patients
• PROLIMB II study aimed at designing, fabricating and validating an affordable body-powered prosthetic fingertip digit with integrated sensory feedback
• DT in VT study aiming to improve outcomes for patients with potentially life-threatening abnormal heart rhythms (arrhythmias)

Professor Ramesh Arasaradnam OBE, Director for the Institute for Precision Diagnostics and Translational Medicine (IPDTM), has been the Chief Investigator (CI) for eight TMU-led trials (the highest number for any CI).

He said: “The TMU team have been invaluable in the efficient running of trials I have led, ensuring the success of research delivery within UHCW and nationally which benefits patients.”

As UHCW is one of very few NHS Trusts to have its own Trials Unit, its patients are often the first in the UK to try out randomised control trials of drugs, testing innovative devices, surgical procedures, physiotherapy interventions and new diagnostic tests.

Working with many supporting departments, academic experts, statisticians, health economists, pharmacists, nurses – as well as involving patients with experience of the condition being researched – regular Trial Management Group (TMG) meetings are held to monitor progress, participant safety and data quality to make sure the trial is delivered on time, to target and according to approved protocol.

Research across multiple specialties is funded by the National Institute for Health and Care Research (NIHR), charities and commercial companies in the UK and abroad.

Shivam Joshi, Clinical Trial Delivery Manager, started in the team in 2016 and has gone on to receive two National Special Commendations from the UK Trial Managers’ Network Trial Manager of the Year Award (2022 and 2024)

He said “Reaching the 10-year milestone would not have been possible without the support of Research and Development colleagues, researchers and participants.

“The team has learned from each trial and grown in confidence. It has also been incredible to see both past and current team members develop professionally, overcoming obstacles collaboratively and independently managing more complex trials. I look forward to seeing the TMU continue to deliver more high-quality UHCW-led research.”

You can find out more about the team, their trials and contact details on the UHCW R&D website.