Last Wednesday (19 April) saw the first One Manchester Translational Research Training Day take place at The University of Manchester. This was another opportunity for the MAHSC Research Office and Education and Training team to work together following the success of the Clinical Research Training day that was held, just over a year ago.
The aim of this event was to address common challenges associated with delivering translational research through practical solutions. Not just about drug and device trials, the event sought to address common pitfalls and challenges associated with the day-to-day running of other complex, interventional studies as well managing quantitative and qualitative data. Following a similar format to the previous event, the first part of the day focused on a series of presentations around four core themes:
- Safety and Reporting
- Robust Trial Management
- Data Management
- Study Close Down
Our speakers were selected from research active organisations in Manchester, each with significant experience in delivering and supporting translational research, and all of whom have encountered and solved many problems over the years and were keen to share with the delegates to avoid similar issues arising in the future and delaying the progress of excellent research.
The welcome address came from Professor Colin Sibley (MAHSC Research Director) who also described the extensive research infrastructure available to support translational research across Manchester.
Next, delegates heard from Charlotte Stockton-Powdrell, from the Research Programme Managers Network, about the opportunities this growing network of over 100 members provides to support and develop project, programme and trial managers, including their brand new development framework shortly to be piloted in a number of organisations across Manchester.
- Session 1 – Safety and Reporting
In the first of three presentations delegates were asked to consider the challenges of delivering research in a lone working situation (which so often occurs) and some practical tips were given by Professor Karina Lovell as to how to overcome them. It was clear from the buzz in the room as people discussed this, just how important it is to get this right and ensure everyone’s safety. It was also evident that this was something that was very close to Karina’s heart.
This then segued seamlessly into the second presentation on adverse event reporting in complex interventional mental health trials. Delegates heard from Professor Gill Haddock about the day-to-day challenges her research team faces when working with people with long-term mental health problems and those at risk of suicide. Gill and her team demonstrated just how important it is to have good systems in place to manage the significant number of adverse events that are reported.
We then finished this session with a stimulating presentation, from Debbie Smith (R&D Lead Research Nurse Manager), on managing the complexities of adverse event reporting in drug and device trials. Debbie’s top tips are essential reading for anyone undertaking a regulated drug or device trial.
- Session 2 – Robust Trial Management
In this next session, delegates were treated to a wealth of top tips from Sharon Hulme, Seamus Byers and Anna Thomason, an experienced ‘A Team’, who shared practical solutions that ranged from: guidance to aid trial managers to deliver a research study to time and target, the vast range of agreements and contracts required to ensure compliance with the rules and regulations associated with clinical trials, to practical tips on resource management, training and data collection. The practical advice provided by these speakers could easily form a compendium of knowledge for both fledgling and experienced trial managers.
- Session 3 – Data Management
During this third session, event attendees were provided with some fantastic top tips that ensure that data collected for a research study is managed and compliant with ethics, good clinical practice and legislation.
Despite a sudden change of speaker on the day due to ill health, Ali Roskell (from our Clinical Trials Unit) stepped into the breach to provide a well-polished and informative presentation on the key principles of robust data management.
There then followed a thought provoking presentation from Professor Andy Vail that highlighted the importance of how, upfront consideration of the data to be collected, will ensure development of case report forms, that are truly fit for purpose, and also mean that manuscripts can be produced before the research has even started, keeping the focus on the real research questions and avoiding the dangers associated with sampling to a forgone conclusion. Andy also provided some top tips associated with data transfer and analysis that, if followed, will minimise stress. Finally, the session was drawn to a close by Dr Sarah Peters, who identified the pitfalls and challenges of collecting qualitative data (audio, video and transcripts), along with some of the associated complexities of consent.
- Session 4 – Study Close Down
In the last morning session, attendees were introduced to the common challenges and pitfalls associated with closing down a research study. Mary Speake, from the Greater Manchester LCRN, kept our audience on their toes as they raced against the countdown clock to come up with the steps involved in closing down a research study. Mary was on hand to fill in the gaps and to provide her top tips to avoid unnecessary stress at a time when researchers are under pressure to commence the next piece of research. She did this by highlighting some of the dangers of not following a robust close down process.
Next up was Dr Hawys Williams, who provided some fantastic practical advice on robust communication throughout the research study, as well a checklist of things to consider with regard to effectively disseminating research findings to all stakeholders, including the research participants and members of the public who may have contributed to study design. There were some great handouts that I would urge you to read.
Finally, as our hungry attendees approached lunchtime, I was given the task of taking the subject of archiving research materials and sharing some of my top tips. Although it is a vital element of the close down procedure, it isn’t the most riveting of subjects to talk about! Realising this was going to be a tall order, I went to my ‘safe place’ of peak time TV quiz shows and took it from there.
After lunch, our attendees returned to hear Professor Kevin O’Brien speak about the exciting new developments occurring in the MAHSC Clinical Trials Unit (CTU) to support clinical trials across Greater Manchester, following significant funding from both the University of Manchester and Health Innovation Manchester. There were lots of questions and interest from within the room.
The second part of the day provided delegates with the opportunity to meet with the speakers to ask them specific questions in a very informal setting. There were also a number of exhibitors at the event including the Research Design Service and the One Manchester Clinical Research Facility.
By 3:30pm the day came to a close and I hope that everyone left knowing more than when they arrived. I would like to take this opportunity to thank all our speakers, attendees, exhibitors, Jane Crosbie, Adam Reekie and Lynn Prime for making the day information rich, lively and collaborative.
The slides, hand out materials and top tips from each session can be found here and our Storify round-up here