Feel inspired: UHS host dedicated EDGE day to strengthen research management

Mikayala King, Research Governance and QA Manager, UHS

For more than 20 years, University Hospitals Southampton NHS Foundation Trust (UHS) has relied on EDGE to support the management of its research portfolio. Today, the system is firmly embedded within the organisation’s research and development processes, providing a central source of information throughout the research lifecycle.

With the introduction of new Key Performance Indicators (KPIs) from the Department of Health and Social Care, designed to measure research set-up times and delivery of research, the UHS R&D team recognised an opportunity to review how they could make the most effective use of all tools available to them.

To explore this, the team held a dedicated focus event around EDGE bringing together staff from across the R&D infrastructure.

Making the most of EDGE

Mikayala King, Research Governance and QA Manager at UHS, explained the thinking behind the event:

“We wanted to ensure that we were using all of the tools available to us to help manage expectations, to be able to react swiftly to changing situations with studies, and to look for trends to enable us to be more efficient.”

For UHS, EDGE is central to achieving this. As Mikayala explains:

“The main tool at our fingertips is EDGE. It is our source of truth and our contemporaneous record of everything that occurs prior to study set-up, including the EOI process, feasibility, and whilst the study is running, amendments and invoicing for activity.”

With EDGE playing such an important role, the team identified the need to ensure that everyone was confident in using the system and understood how information was captured, stored, retrieved, and subsequently reported.

A day focused on data, processes and collaboration

The full-day event provided an opportunity for different staff groups across the R&D department to refresh their knowledge of EDGE and explore how the system is being used across UHS.

Key areas covered during the day included:

• How UHS uses EDGE throughout the research lifecycle.

• The importance of data integrity.

• The value of timely and complete data entry.

• Where information is stored within EDGE and how it can be retrieved.

• How EDGE data is used and reported across the wider R&D department.

• Opportunities to improve workflows and make better use of existing functionality.

• Ideas for additional functionality that could provide greater insight into studies and support more efficient working.

The event was not simply about refreshing existing knowledge. It also created a forum for staff to share their experiences, identify challenges, and suggest ways that EDGE could be used more effectively.

Turning discussion into action

The event has already led to tangible improvements within UHS.

Following the discussions, changes have been made to forms and workflows, while data input has improved. The team is also planning a further event focused specifically on finance, recognising the importance of ensuring that financial information is managed as effectively as other areas of the research portfolio.

The team also identified areas where improvements and clarification would be valuable at a wider level. This includes suggestions to the NIHR around the handling and reporting of sub-studies and platform trials, as well as questions about where the data used to populate EDGE from CPMS is sourced.

Learning through practical activities

To reinforce the importance of good data management, the team took an engaging and creative approach during the day.

The importance of timely data entry was demonstrated using Rubik’s Cubes, while data integrity was explored through doctored jigsaw puzzles. The team also used doctored origami instructions to highlight the importance of clear and accurate instructions.

These practical exercises helped turn what can sometimes feel like abstract concepts into memorable, hands-on examples of how small errors, delays, or inconsistencies can affect the bigger picture.

Looking ahead: The next 20 years

For UHS, the focus event demonstrated the value of stepping back from day-to-day processes to review how systems, data, and people work together.

The team plans to continue pushing EDGE as far as possible, while working collaboratively with the EDGE team to explore opportunities for further development and improvement.

UHS plans to ensure that EDGE continues to be the trusted source of truth for research studies and that it remains a fundamental part of research management for many years to come.

UHS attendees of the EDGE day

From EDGE user to EDGE team: Beth Mathis

CIRU Marketing Manager, Beth Mathis

Prior to my current position at EDGE, I worked in a few different research-based roles where I was first introduced to EDGE and, in fact, became a user of the system myself.

My research journey began in 2012 when I joined University Hospitals Southampton NHS Foundation Trust as a Pharmacy Support Worker in Clinical Trials. My main tasks included dispensing clinical trial medication, setting up trial folders and receipting trial drugs. I soon progressed to Senior Pharmacy Support Worker and later to Clinical Trials Coordinator, where I worked on mostly Oncology studies.

It was during these roles that I was introduced to EDGE, and it quickly became a helpful tool in my day-to-day work. I used it to help identify trial patients when prescriptions came into the pharmacy. It was also useful for gathering additional information that a Pharmacist might need, particularly when working in the main Oncology pharmacy, where clinical trials was just a small part of the medication dispensed in the dispensary and produced in the clean rooms.

My roles within Pharmacy involved a lot of paperwork including the upkeep of drug accountability logs, staff logs, drug destruction logs, and delegation logs. One thing I clearly remember was the amount of effort it could take to get, in particular, a delegation log completed. I was often hunting down a nurse or Principal Investigator (PI) for their paper signature, or trying to track down the paper log that had been left in a tray somewhere waiting to be returned. This certainly gave me an insight into the challenges and hassle that come with maintaining paper documentation for clinical trials.

After nearly three years in Pharmacy, I moved up to the Trust’s R&D department. This meant a small pay rise, but also a significant increase in the number of steps I did each day, walking all the way up to E Level! My role as a Research Assistant was heavily administrative and meant I worked with EDGE much more regularly. My main responsibilities included adding studies to the system and transferring information from both electronic and paper documentation.

I stayed within R&D for just over six months before discovering a vacancy within the EDGE team, which was based at UHS. I applied, had an interview, and soon became a Knowledge Support Analyst for the EDGE team. In this role, I supported the Knowledge Officers with implementations and support queries, while also beginning to work on new functionality for EDGE.

I was assigned specifications for new patient SAE functionality and, yes, you guessed it, a new electronic delegation log! I worked alongside our dedicated development team and other Knowledge team members to help design and build these new features. It was a great opportunity to take my experience as an EDGE user and use it to help shape the system itself.

A couple of years later, I moved into a brand-new role in Marketing and Communications, progressing to my current role as CIRU Marketing Manager. Today, I contribute to the direction of marketing and communications for our department, build on our user communication strategy and develop a number of EDGE Community channels. These channels help our user base enhance their EDGE skills, share knowledge, and connect members together to find better ways of working.

I do believe that having both the user experience and the ‘on-the-ground’ experience of working in clinical trials has really helped me in my role at EDGE. It has given me a valuable perspective when it comes to system development and communicating with our community.

Most importantly, it has helped me think like a user and understand the importance of putting the user at the forefront of what we do.

Say hello to our new logo. EDGE 3.

At the end of last year we announced that we plan to launch EDGE 3, a new version of EDGE (our Clinical Trials Management Progamme) by autumn of this year (ahhh exciting). A new version means a new look and feel of the application which also means a new logo!

Our EDGE 3 logo has already been shared in some past communications but we thought it would be a good idea to shout about it some more and get our users used to the new design and build up some excitement. Oh and because we are pretty damn proud of it. This is also a great opportunity to share with you our plans on our branding so you are kept in the loop as an important EDGE community member (that’s to those of you who are reading this and use EDGE at your organisation).

So, over the years you may have seen a few different logo variations knocking about. Most of you will know of the EDGE logo currently used on the database as well as our EDGE marketing logo used on a lot of our printed/digital media and at our well known EDGE user conference (you know you must remember that giant green spinning EDGE light in the main conference room). That’s the one! Well, to make things a little simpler and more cohesive, we are planning on using the one logo going forward from EDGE 3 launch date, so you will see the EDGE 3 logo on the system itself, our website, and on all branding and marketing materials, and of course at the future EDGE conferences (yep that means a new spinning light, banners, new merchandise, and a new outfit for our furry friend EDGEY, our very popular little hedgehog mascot).

The new EDGE logo was created by our one and only Creative Designer Gela Jenssen who designs all of our unit’s graphic materials, animations and creative pieces. Gela has created a more modern and sleek logo which not only represents the EDGE brand in a stronger, more up to date way, but also ties in nicely with the other service groups we supply here at CIRU. This was something that was very important to ensure we inline each of them together to build on the overall brand of our unit, the CIRU brand. When I asked Gela about her new logo design, she explained how it was about capturing and celebrating the unique qualities and values of the EDGE programme and EDGE team, full quote found below.

Your see we kept the EDGE green for the logo (of course) and plan to use this against a selection of on brand colours. The new logo design is more refined and is an evolution of previous logos, it can scale easily and work better in many more places. We hope you like the new logo, it is still very us, still very EDGE. We look forward to getting this rolled out across our print and digital platforms and of course on the new version of EDGE!

Keep a look out for more EDGE 3 updates and news from us coming soon.  

“For me personally as a designer, creating the EDGE 3 logo has been about capturing and celebrating the unique qualities and values of the EDGE programme and the EDGE team who is working incredibly hard to make it accessible to everyone and working well 24/7, here in the UK and globally.”

— Gela Jenssen, Creative Designer, CIRU

What will the future of clinical research look like?

Now, that is an interesting question, and if anyone tells you they know the answer then they are lying. Nobody can predict the future accurately, however we should at least try and work out the rough direction that we are heading in order to prepare for it as best as possible, knowing that we will still need to adapt over time as things change.

This reminds me of a quote from Mark Twain, ‘It ain’t what you don’t know that gets you into trouble. It’s what you know for sure that just ain’t so’.

Uncertainty was echoed in the ex-governor of the Bank of England Mervyn King’s book; The end of Alchemy, where he explained that regardless of the economic models that have been designed by the smartest minds throughout the decades from Bagehot to Friedman and Keynes, it is radical uncertainty that prevents us being able to truly know the future.

So let’s start with a few of the things that we do know:

1.      Use of technology is increasing, the time we spend online has doubled over the past 10 years [i], however increase in labour productivity in the UK, which has been on an almost straight line trajectory since 1971 has started to tail off since the global financial crisis in 2008[ii].

2.      Clinical trials are costing more and taking longer to complete[iii], both of which will impact R&D investment decisions by Pharmaceutical companies, as well as concentration and investment by governments on improving the setup and delivery of research. The UK Government has already committed to increasing the share of GDP spent on R&D to 2.4% by 2027[iv]

3.      Geopolitical tensions are high; The UK in a transition period out of the EU; Countries like Greece and Italy within the EU are trapped in a debt cycle, trade tensions are high between the US and China.

4.      The departure of the UK from the EU, and therefore binding EU legislation, will mean the alignment between the two may be subject to change. The new EU Clinical Trials Regulation (CTR) will not be in force in the EU at the time that the UK exits the EU and so will not be incorporated into UK law on exit day. The Government issued an update on the CTR during the implementation period, with a clear commitment to align where possible with the CTR without delay when it does come into force in the EU, subject to usual parliamentary approvals.[v]

The outcome of these points means the UK will need to position itself competitively to continue to attract high quality researchers and research, whilst maintaining alignment with the EU in certain legislative aspects that streamline international setup and delivery. The departure from the EU may provide opportunities in the UK to create legislation and policy to increase the attractiveness of conducting research, although this will no doubt be tempered by the relationship the UK will still need to have with the EU in order to access certain services.

For the UK, and any country in fact, to improve its attractiveness as a research hub, one key aspect is efficiency. Efficiency drives down costs and increases speed, both of which are obvious attractions in relation to point 2 mentioned above. Efficiencies can rarely be achieved by individuals and instead require people to work together to solve problems at a large scale.

So despite the UK leaving the EU, and despite rising geopolitical tensions across the world, in order to solve the labour productivity issues and to reduce the cost of delivering clinical research, people will need to work together more than ever.

For years now, this is what our department has been trying to achieve subtly through the use of technology such as EDGE, but also through the social interactions that surround technology and how we work with and interact with the research community, both in the UK and beyond. By realising the potential of integrated research ecosystems, both technological and community, we can finally start to address the efficiencies and productivity gaps. EDGE is now used across 80% of NHS Trusts, broadly across Scotland and also Northern Ireland. If this reached 100%, we could finally have a competitive advantage to increase the attraction of research to the UK through a single national standardised research management platform used by all public Hospitals. This platform could be leveraged to engage sites with sponsors and offer new research opportunities to patients.

This situations is not unique to the UK though, and with other countries joining in with the EDGE programme, the benefits of working together, solving problems as a collective, sharing best practice and reducing duplication will all lead to the improvements in the delivery of clinical research that ultimately benefit the patients we serve.

[i] www.ofcom.org.uk/about-ofcom/latest/media/media-releases/2015/time-spent-online-doubles-in-a-decade

[ii] www.tradingeconomics.com/united-kingdom/productivity

[iii] https://www.ohe.org/system/files/private/publications/380%20-%20R%26D%20Cost%20NME%20Mestre-Ferrandiz%202012.pdf?download=1

[iv] https://www.abpi.org.uk/media/7607/rmi-0128-0919-clinical-trials-report.pdf

[v] https://www.gov.uk/government/publications/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal

Take Research To New Heights

I wanted to start by saying thanks to everyone who attended the 2020 conference which we held at Farnborough International Exhibition and Conference Centre earlier this month. It was a real success with close to 400 delegates through the door.

Thank you also to our wonderful speakers who brought their knowledge, expertise and humour to the event, allowing delegates to learn in a relaxed but productive way. Thanks to our new and returning sponsors and exhibitors, who provided support for the event as well as interacted with delegates during the lunchtimes.

This year we changed hosts and had Dr Kevin Fong lead the main room and introduce all of our keynote speakers. As a medical doctor and space medicine expert, Kevin was very fitting for this role with our aviation inspired theme.

We tried to keep to the new heights and airport theme as much as possible by having a bag drop area for delegates, e-ticket registration process and electronic screens which displayed the agenda in a departure board style layout - just a few things to add to the overall conference experience.

Us a team are extremely happy with the way the conference went and we believe the choice of venue (being located next to Farnborough airport) was an excellent one for our theme – TAKE RESEARCH TO NEW HEIGHTS. The venue allowed us to use multiple rooms to host user-led breakout and workshop sessions specifically on EDGE functionality and experiences. The conference also played a big part in celebrating 20 years of EDGE at the Clinical Informatics Research Unit as this was highlighted throughout the day by our hosts, as well as a special 2020 puzzle we had displayed in the networking area.

One of my highlights of the event was having Freddie, a 9-year-old boy present all by himself on how research has helped his life dramatically after having a severe peanut allergy. His presentation was a lovely reminder to why everyone is doing the job they are doing, for the patient. I also can’t forget the opening of the conference which was definitely another highlight for me. Here we had an airline safety demonstration by some members of the EDGE team, this certainly brought some laughs to the room and reminded delegates of some useful information, like remembering to wear their passports (delegate badges) at all times.

We are now thinking about what to do in 2021 and will be working on ways to improve the conference following useful feedback provided by delegates through an online survey.

Look out for future news coming from us with our 2021 plans!