clinical research

A day in the life of a Knowledge Officer

A day in the life

of a Knowledge Officer

To be honest, one of the reasons I enjoy being a Knowledge Officer (KO) is that the days are never the same. I wouldn’t be able to stay in a job where the days are similar with the same repetitive tasks. Doing the same thing repeatedly always reminds me one of those movie plots where the main characters keep reliving the same day until they find a way to break the vicious cycle. Luckily, the KO position has a broad range of responsibilities and could be described like a ‘Jack of all trades’. Therefore, it keeps my professional life interesting and constantly providing new challenges.

Whenever someone asks me what my job is and I say Knowledge Officer, this usually leads to a couple of minutes of questions about what a KO actually is. My explanation generally revolves around the concept that is a mixture between account/project/product management for an IT clinical research organisation. Normally, it is also useful to describe some of the duties to provide a better picture with the explanation. These duties include, in first place, the support to our users, such as replying to data management, reporting, and training queries. On the other hand, we also have to manage specific projects that differ for each KO within the team (in my case the EDGE/CPMS integration for UK) and deal with enquires of other organisations that want to collaborate with or use EDGE.

Furthermore, we need to envision how EDGE will look in the future by trying to understand the ever-changing clinical research environment. Therefore, we need to keep up to date with developments within clinical research, trends, and changes to regulation. An additional challenge is the fact that EDGE is used in various countries, so we need to have a basic understanding of the particularities of each of them. Ideally, any new functionality would be useful worldwide and benefit most of our users for each of the different countries.

As a KO, we are quite often in a position of a mediator. A good example of this is mediation between EDGE users and the CIRU development team to develop new functionalities. Consequently, we must be able to promote discussions, listen to different point of views, and steer the discussion into a realistic shared goal. The ability to create good working relationships with people of different areas and levels of seniority is essential. In my opinion, one of the most important duties as a KO is to facilitate discussions which can lead to the enhancement of the EDGE system, which then becomes valuable to our users.

A bit of EDGE history

EDGE clinical

A bit of EDGE history

Discover something new about the EDGE programme

The new year marks another milestone for EDGE, reaching 22 years of innovative clinical research management. As we enter the new year, we thought it would be a great opportunity to share some history behind EDGE and how it has grown throughout the years.

Let’s go back to the year 2000 when EDGE wasn’t actually called EDGE, it was called NOTIS (Network Oncology Trial System). Our Director, Professor James Batchelor, at this time was setting up Southampton’s Cancer Research Network, working for the University of Southampton, based at Southampton General Hospital. During this time James realised that no one actually knew what research was taking place on a broader scale, they only really knew what was happening locally. There were no web-based systems in place and all information that was needed to report back to the Coordinating Centre as a CRN was on paper. James knew that they needed to take an existing internal system (NOTIS) and transform it into something that was web-based and would allow other research centres to join and collaborate. The journey began. James and his colleague, David Miller (who was the only Developer at the time), set to work on making the idea into reality.

NOTIS changed in 2002 and it became ETIS (Enterprise Trial Information System). Unfortunately, when people Googled it, they quickly discovered it was the same acronym used for the global elephant tracking information system. This lead to lots of people trying to log in to track elephants instead of clinical trials! As you can imagine, this wasn’t ideal, so the name changed again for a third and final time to EDGE, with version 1 of the EDGE platform launching in 2005. You might be wondering, ‘What does EDGE stand for?’ The fact is EDGE was just a code name and it doesn’t actually stand for anything! Nevertheless, the name has certainly worked extremely well and has developed into the EDGE programme it is today.

Fast forward to 2007, where further members joined the team, including Lawrence Surey and Tobias Carlton-Prangnell. (This meant James and David had more company in the University of Southampton’s basement of the Duthie building!) Lawrence was employed to offer support to end-users and Tobias took the first Knowledge Officer position to manage the EDGE accounts. A year later, our second Developer started, Andy Bush, who along with James, David, and Lawrence, are still working here today.

As the years passed, more and more members joined the department to support the ever-growing EDGE user-base and as of today, EDGE is implemented in over 80% of the NHS throughout the UK whilst making an impact globally. EDGE subscriptions are now throughout Canada, as well as within a number of other countries including New Zealand, South Africa, Belgium, India and South Australia. We support over 32,000 users with still a relatively small team of 5 Knowledge Officers, 4 Developers, 1 Test Analyst and 1 Data Analyst. The department as a whole (CIRU) has grown massively, however, with close to 50 staff members, the majority of whom work on non-EDGE related things.

A lot of people think we (EDGE) are a commercial company, making lots and lots of money, with hundreds of staff but they couldn’t be more wrong. We are just a small team from a not-for-profit University department, but it’s safe to say we are doing BIG things.

What will the future of clinical research look like?

Future of clinical research

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

EDGE 3 launch scheduled for autumn 2021

EDGE 3

We recently shared the exciting news with our users that we are planning the launch of EDGE 3 for autumn 2021. This will be following years of hard work by both our Development and Knowledge teams who have been devoted to bringing a new and improved version of the programme to all users globally.

EDGE 3 will be a complete system overhaul from EDGE 2, not only having a brand new interface but it will also contain enhanced features and functionality, making things easier and faster to use. Other positives include: improved user experience using new browser technology, support on multiple devices, faster turnaround time for new functionality development and an improved help & support centre. Further innovation is in the pipeline for EDGE 3 which will be communicated to EDGE users, along with regular updates on the progress. We will also be sharing important information regarding the shutdown of EDGE 2, as well as training and support guidance to ensure users are fully prepared for the new programme.

We will also be engaging with users on the development, testing and feedback of EDGE 3 at relevant times so keep your eyes peeled for further updates from us. Whilst all of the EDGE 3 work is taking place, our Knowledge and Development teams are continuing to support users on EDGE 2 as well as keeping up with the systems maintenance and working on any critical changes when required.  

We are looking forward to sharing more information in the upcoming months - watch this space!

And to finish this short but sweet post, Dave Osler, Head of Knowledge provided me with the following quote which I thought I would share here:

“To say I am excited about the release of EDGE 3 is an understatement. Software is a rapidly evolving area, just look at the companies in the world like Apple, Tesla and Netflix, all able to deliver experiences to people that could barely be imagined 20 years ago. Building applications using new technologies is critical to achieve this, old technology simply cannot cut it anymore in today’s rapidly evolving environment. By utilising these new technologies, we can make huge strides forward at pace to deliver the solutions people need, when they need them. Clinical Research itself is rapidly evolving and needs organisations that can keep pace with it. Ultimately, research management is about delivering better care for patients and EDGE 3 will be the cornerstone that supports us all in delivering this”.

Check out our EDGE 3 promotional animation here.

What the EDGE team are up to

Dave Osler EDGE

It’s been 2 months in lockdown now and our entire department is working from home, so I thought I’d take some time to bring everyone up to speed on what the EDGE team are up to.

Firstly, it hasn’t quite been the start that we hoped for our new developer Grant, a Doctor by training, which is a unique skill set that I am sure will be very valuable. He officially started with us whilst in lockdown, so although we’ve virtually met him, many of us haven’t yet met him in person. Although in the world of remote working and geographically diverse companies, perhaps it isn’t unusual for colleagues to have never met in person?

Our team have daily meetings, and in fact these often becomes multiple daily meetings between sub-groups of us as we work on different projects. Our concentration is heavily EDGE 3 development, using this time to concentrate on designing new specifications for functionality, as well as enhancements for the current functions EDGE 2 already provides. Functions are great, however a system is not built simply on functions. Usability is a very important aspect of systems and a functionally rich application is of little use if nobody can work out how to use it, or find it so confusing or complex that they end up looking for workarounds.

Our team are doing a lot of engaging with many of you to find out how you use the system and gather as much feedback as possible, as well as using the skills and knowledge of our departmental Psychologist Kenny. He is, at this moment, integrating data analysis around how users navigate throughout the system, which functions are most used, and how users navigate to those functions. There are a multitude of different types of people who use EDGE, each with different job roles, so although the search for absolute perfection may end up being fruitless, there are certainly a lot of improvements we already have lined up.

There is currently no fixed release date for EDGE 3, although we are aiming for sometime late in 2021. As we approach that time we can start to be more specific, however until then we have a lot of problems to solve, challenges to overcome, cans of worms to open, ducks to line up and all other types of analogy. However I am confident that EDGE 3 will be the product that we all are hoping for, both in terms of functions available to users, integration possibilities to other systems, and also importantly, a technologically up-to-date framework that allows our developers to continue building new and exciting functions at speed, something which is more difficult currently in EDGE 2.

Now for the sad news. The event of the year for many people, the eminent social and educational soiree that is the yearly EDGE conference is diverging from its usually perennial perpetualness. Or in other words, we’re moving it. Whilst we are in the throws of designing and building EDGE 3, it is perhaps better that we continue to concentrate on this, and when ready, create a conference specifically around the launch of the new version. Our marcoms team, Beth, Gela and Kenny will as always keep you all informed well before the event so that you can book your tickets before they sell out.

Be sure to visit the CIRU website for more information on other work taking place in our department, to keep up to date with what we are up to, or even to browse out staff pictures and put faces to the names of people you often speak with.

Exploration of EDGE Functionality

explore.jpg

Our use of technology and the role it plays in our lives is increasing, both in and out of the workplace, with it even reaching levels of addiction in some instances, case in point where the World Health Organisations now includes a classification of ‘Gaming Disorder’ in their new International Classification of Disease (ICD-11). 

This raises an important question about how effectively we use technology and how that technology benefits us in return, especially within the workplace where most often the technology is provided to us, rather than being chosen by us. The Health Secretary Matt Hancock is a big advocate of digital technology and has already expressed a strong desire to unlock its full potential in the NHS, after describing it as the “worlds most frustrating place to work for its IT” at the Health and Care Innovation Expo in Manchester. 

Here in the Clinical Informatics Research Unit, our Knowledge Officers spend a lot of time working with hospitals and research organisations to ensure that the systems they use provide them with maximum benefit, helping them to understand the full range of functions available. This includes how they can utilize it in different ways in order to streamline processes and improve operational efficiencies, or in layman’s terms just making it more useful and helpful. 

Every organization uses the system differently, and subsequently every organisation will experience different benefits. This is not to say that the system is different between organisations, it is after all the same system, instead it is down to the heterogeneity of each organisation, notably which other systems are already being used, and how, in this case, EDGE has been implemented. 

Part of what we do as a team, and as a community is to share best practice and we see this in so many different areas, most recently with primary care and pharmacy groups being created, and this cooperative working is not limited to the NHS. Colleagues using EDGE from Canada are just as willing to share their work and are just as receptive to the innovations from the UK because, lets face it, we are all trying to provide the best environment and best infrastructure to provide opportunities for patients to take part in research. 

Something that I have noticed on my travels is that there are sometimes functions in EDGE that people didn’t realise were there, or maybe didn’t see how they could really benefit them. This is where I intend to offer out some advice on different aspects of how the system can be used over the next few months, to ensure that people can make the most of the system and ultimately to make sure that the technology is effective, is benefiting peoples work and ultimately reduces the view that the NHS, or other healthcare providers are ‘frustrating places to work for its IT’. 

In this first instalment, I bring some work from Gaurika Kapoor, Operations Manager at Alder Hey Clinical Research Facility, in which she has created an Entity on EDGE for the purposes of collecting data for their NIHR CRF Annual Reports. This is going to be used to standardise their approach to capturing the information and providing a central place for reporting. 

This has now been published into the Global Library, for all EDGE Admins to download if they so wish and can be found on EDGE by going to LIBRARY > ENTITIES > ADD GLOBAL ENTITY > click ‘CRF’. 

Once you click on it a copy will be downloaded into your library, allowing you to add, edit or delete sections in order to use it for your own data collection requirements. *And just to clarify, changing your version of it will not affect anyone else’s copy. 

There are many other Entities available in this library which have been shared by organisations who believe they would be useful to others, so go and check it out and see if anything you like. On a side note, over time this library has become quite busy, so I will add a ‘to do’ to my list and see if we can clean this up a bit. 

Thanks for reading and keep watching out for the next series, where I will go into more depth around other functions that you could use in EDGE.