Saving & Improving Lives

Saving & improving lives:

the future of UK clinical research delivery

Yesterday the UK government and devolved administrations have published their vision: ‘To unleash the full potential of clinical research delivery to tackle health inequalities, bolster economic recovery and to improve the lives of people across the UK’.

The full document can be accessed here

The report has 5 key themes; Embed research in the NHS, make it patient centred, make it more streamlined and efficient, leverage digital tools and data and create a sustainable and support workforce. These themes will be supported through the newly formed UK Clinical Research RRG programme (Recovery, Resilience, Growth).

Underlying this report are 7 specific areas for action:

1.    Improving the speed and efficiency of study setup. This includes expediting costing, contracting and approvals.

2.    Building upon digital platforms to deliver clinical research.

3.    Increasing the use of innovative research designs.

4.    Aligning research programmes and processes with the needs of the UK health and care systems.

5.    Improving visibility and making research matter to the NHS.

6.    Making research  more  diverse  and  more  relevant  to  the whole UK.

7.    Strengthening public, patient and service user involvement in research.

If you have ever read Best Research for Best Health released by the DoH in 2006, Personalised Health and Care 2020 released by the DoH in 2014, or Improving the Health of the public by 2040 released by the Academy of Medical Sciences in 2016, you’ll see a running theme over the last 15 years of speeding up research, leveraging digital tools, using data effectively and building a skilled and resilient workforce.

Since joining the Clinical Informatics Research Unit in 2012 and working on research issues at both a national level as well as a local level, across multiple countries in the world, the UK still has a strong leading edge. Many of the practices developed in the UK are researched and copied to other countries to mimic the successful support and delivery structures that we have. This is something to be extremely proud of and is partly down to the vision delivered in the publications mentioned earlier that are then built upon over time by everyone involved in research.

To ensure we continue to attract the best research and best researchers to the UK we need to maintain tour competitive advantage, the thing that attracts those people to our shores. Most people use the Quality, Speed, Cost triangle to show that things can be delivered at either high quality, fast or cheap, but not all 3, each trading off with the others. However technology can help to shift this paradigm and reduce those trade off’s, not completely, but enough to allow a noticeable reduction in cost, with faster and higher quality outcomes. 

Peter Thiel, co-founder of PayPal and Palantir, says in his 2014 book Zero to One “As a good rule of thumb, proprietary technology must be at least 10 times better than its closest substitute in some important dimension to lead to a real monopolistic advantage.” Now I don’t think that from a national clinical research perspective any country can leverage a 10x improvement over all other countries, yet the small changes and improvements that we all make on a daily basis, whether off our own back or guided (or pushed) by the DoH vision all add up over the long term, making the UK an attractive place to deliver research.

So, if like me you’ve read the report, then digest it, think about it, work out the part you play, whether large or small and plan what changes you can make. To me, aligning what we are doing with EDGE and all our other research services ensures that we are, for want of a better expression, all pulling in the same direction.

Useful links:

https://www.gov.uk/government/publications/best-research-for-best-health-a-new-national-health-research-strategy

https://www.gov.uk/government/publications/personalised-health-and-care-2020

https://acmedsci.ac.uk/policy/policy-projects/health-of-the-public-in-2040

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

Hello to 2021

Well, 2021 has arrived and it is a year that is going to bring a lot of exciting changes in the world of EDGE. As you all know, we are in the process of building the next version of EDGE, (version 3!!!) and we aim to have this completed, tested and ready to release at the end of this year. We cannot be too specific with dates at the moment, however as soon as we are able to we will be let you know.

It’s important that we release the new version, both for an update to the user interface to keep pace with modern technology, but also to allow us to update the back end of the system, the part which none of you will see, but the part which is critical to integrating to other systems and becoming part of a bigger ecosystem.

We will certainly try and pack in as many new functions as possible before release, however we won’t delay the release to put in new features, it makes more sense to release a new version with all the core functions of EDGE 2, and then build upon those with the new technologies we have available. There’s no point in us keeping the shiny new version under wraps for longer than we need to, we want to get it out there for everyone to use!

New functions in a system are always good, but whilst we wait for EDGE 3 to be built, I often ask myself the question ‘what more can we do with what we already have?’. I think the answer is a lot, and so I want to spend a good part of the next few months looking at those opportunities like remote monitoring, e-TMF and e-ISF, expanded use of electronic delegation logs and more. There is a huge opportunity in these areas, and to be able to use something you’ve already got makes a lot of sense, so watch this space.

I’d like to take the opportunity to congratulate a colleague that we know well here in Southampton, Dr Matt Westmore, who is moving from his role as the Director of the Wessex Institute to become the Chief Executive of the HRA. We’ve worked with Matt closely over the years and know that he will be a huge success in his new role.

Lastly, I want to thank the whole team here at CIRU for their continued dedication to delivering EDGE globally and genuinely striving to make a difference in research. A well-deserved thanks to all of our EDGE users is also due, especially now EDGE has over 6 million patients recorded on the system and that doesn’t happen overnight or by accident. It’s been nearly 2 decades of hard work and I think that deserves some recognition.

To everyone reading this, and even those that aren’t, I hope you have a great start to 2021.

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

EDGE 3 launch scheduled for autumn 2021

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.

Patient information & data linkage

Across the UK I don’t think there are 2 hospitals that collect exactly the same information about patients and participants on EDGE, each organisation varies. This is usually dependent upon a number of factors including size of the organisation, what their research portfolio looks like, other IT infrastructure already in place and lastly the depth of the implementation of EDGE within clinical teams.

There is also a clear emerging trend in interest from the Department of Health about what the national research portfolio looks like in depth, originating out of reports such as the Children, Teenage and Young Adults Cancers report, collated by the National Cancer Registration and Analysis Service.

Collecting Dates of birth, or age, on EDGE in order to comply with the CTYA reports as well as to expand this further than Cancer have come up in more and more discussions over the past year and this has often raised the question about collecting the data in EDGE. Some Hospitals allow their staff to collect patient identifiable information in EDGE, others do not and this is wherein part of the challenge lies. Whilst EDGE is capable of collecting the data, the next challenge is getting the Caldecott Guardian to understand and authorise this process. Even once you are at this point, the final challenge is to ensure clinical staff actually enter the data.

Capturing patient information on EDGE has often been misconstrued, a few examples of which I will give:

We once had a call to our office from a Chief Investigator demanding that we delete all the data relating to their research from EDGE, because it was their data, not ours. We explained that it is actually the hospitals data, not the CI’s and certainly not the EDGE teams. The data is collected by the hospital in a system they contract the University of Southampton to provide, in order to manage the delivery of their research services.

In the past I have spoken to an R&D department who would not let clinical staff enter any patient identifiable information because the R&D department did not need that information. This is in itself a very interesting point and one that is easily misunderstood. Historically R&D systems have been silo’s of information only capturing information relevant to R&D. EDGE expands across the boundary from R&D to Clinical teams, providing a platform for clinical staff to track and manage their patients through the life of the project, aiding those clinical staff in providing their legal duty of care to that patient. Therefore clinical staff entering patient identifiable data is not for R&D, but for their own duty of care.

Interestingly, this leads on to the discussion of consent. A number of Caldecott Guardians that I have spoken to who have prevented staff from capturing patient identifiable information on EDGE have done so with the justification that the patient has not consented to have their information stored. This is where there can be an easily confused line between patient care and research. The patient data being stored on EDGE is not answering the research question, the data for which goes into the Case Report Form and subsequently to the sponsor. The data in EDGE allows the clinical staff to provide direct care to the patient, the terms and legal justification of which can often found under an organisations Privacy Notice. The data is also not being given to the University of Southampton, we are simply providing a contracted service for the provision of the system.

Once you reach the point that R&D and the Caldecott guardian are on board, now the real challenge comes to engage the clinical teams. This can be extremely challenging and can vary on a team by team basis, for example, some teams may already have access to IT systems that meet all their needs, whether these are bespoke systems or products such as the calendar in Microsoft Outlook. A misconception is that the Electronic Health Record system in a hospital captures all the information needed for patients. In standard care that might be the case, but often not in research, leading to clinical staff keeping having to find combinations of other systems to use. From my experience, clinical research staff tend to keep a lot of spread sheets to meet these needs and this is where, when implemented in depth, EDGE can replace the need for a lot of those other systems. Thereby providing a useful tool to the clinical staff and cutting down on data duplication.

Now, if the clinical staff are able to use EDGE to facilitate them in managing their research, and NHS numbers can be recorded, this opens up the door to many opportunities for data linkage to answer the questions from the Department of Health and other bodies. A simple NHS number, combined with NHS Spine could mean that supplementary information such as Date of Birth do not need to be captured on EDGE (if the clinical staff  don’t need it for the patients care) as this can be provided through data linkage.

Using the NHS number alongside patient records is something that has been encouraged for a long time, with the Information Governance Alliance advising ‘The NHS Number should be used in Health and Social Care Organisations and environments as long as the purpose is to communicate with those who are involved in providing care’.

Or alternatively the previous NHS Medical Director Professor Sir Bruce Keogh, who was the Senior Responsible Officer for the NHS Number Programme, saying: “We should no longer accept the level of misallocated records and the misidentification of patients as inevitable or normal.  We must change the way we work and identify all patients by their NHS Number which will reduce potential errors and harm in the future.”

The NHS Business Services Authority takes a similar stance in their ‘Pseudonymisation and anonymisation of data policy’, ‘If patient data is required the NHS Number is the most secure form of identifiable data. The NHS Number should be included within all patient records and documentation in line with the current Connecting for Health NHS Number Campaign.

And finally, in the NHS Standard Contract 2017/19 and 2018/19 Service conditions, it states:

‘NHS Number

23.4 Subject to and in accordance with Law and Guidance the Provider must:

23.4.1 ensure that the Service User Health Record includes the Service User’s verified NHS Number;

23.4.2 use the NHS Number as the consistent identifier in all clinical correspondence (paper or electronic) and in all information it processes in relation to the Service User; and

23.4.3 be able to use the NHS Number to identify all Activity relating to a Service User.’

I have written this not to enforce any organisation to use the system in any particular format, but instead to show that there is a legitimate argument to collect certain information which in turn could provide benefit to system users, as well as being able to easily link data to provide reporting capabilities that future proof research reporting, both locally and nationally. However, it is up to each organisation to choose the functions within EDGE they use, and I hope that if this is a path you wish to take, that this has been helpful.