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Celebrating International Clinical Trial’s Day in the North East and North Cumbria

ICTD

Today (20 May) marks International Clinical Trial’s Day. The day celebrates the anniversary of the first clinical trial by James Lind in 1747 into the causes of scurvy on board the HMS Salisbury. His trial consisted of just 12 men, grouped into pairs and given a variety of dietary supplements from cider to oranges and lemons. The trial only lasted six days but, within that time, there was a noticeable improvement in the group eating the fruit, providing Lind with the evidence required of the link between citrus fruits and scurvy.

In the North East and North Cumbria we have a lot of National Institute for Health Research infrastructure, including the Newcastle Biomedical Research Centre (BRC), Clinical Research Network North East and North Cumbria (CRN NENC), Newcastle In Vitro Diagnostics Cooperative (MIC) and Newcastle Clinical Research Facility (CRF).

We’re sharing how COVID has changed the way research is done.

Kasia Kurowska is the Patient and Public Involvement and Engagement (PPIE) Manager for the Newcastle BRC, CRF and MIC.

COVID has had both positive and negative impacts on the PPIE work of BRC, CRF and MIC. Moving all PPIE activity online during COVID has meant we are able to reach many more people and involve them in our research. This includes many people who couldn’t get involved before such as those living in rural areas, housebound due to health conditions or working age people who usually wouldn’t have time to travel and get involved in PPIE research. This has been incredibly positive. The biggest negative of COVID is that those not digitally engaged are missing out on the chance to get involved in research at the moment. By covering the BRC, CRF and MIC in a dedicated PPIE role I have been able to minimise the impact COVID has had on our PPIE research work.

The main change to our PPIE research activity during COVID has been to make it all online. We have also focused on trying to make more connections with people during the lockdown, allowing more social time on calls to check how people are and remember that whilst our research and PPIE activity is important we also have a responsibility to check on the wellbeing of our public contributors at this stressful and unprecedented time. We really hope to get back to some face to face PPIE soon but I think online PPIE is here to stay too!

It is so important that we promote not just the opportunity to participate in clinical trials but also the chances to get involved in helping shape, decide and deliver the research. #BePartofResearch is a great starting point for people to find out more. My advice would be if you enjoy participating in research then ask the research staff how you can get more involved when you’re next taking part!

Dr Alan Bagnall is the Deputy Clinical Director at NIHR CRN NENC and he took the time to tell us about his first year as Clinical Director.

I took up the role of Deputy Clinical Director in March 2020, and was immediately faced with the challenges of the Covid pandemic and how we would deliver Urgent Public Health research. So, you could say very little has changed since I haven’t known anything different! In a broader sense though, the key change for me was witnessing the truly collaborative working between different hospitals and different LCRNs that enabled us to be successful despite the enormous challenges we faced.

The key positive to come out of the pandemic for me was to challenge the way we deliver research. Through necessity we are now delivering innovations like fully virtual trials that might otherwise have taken years to come to fruition. I think these will enable more patients to enjoy the benefits of taking part in research by reducing the inconvenience of hospital visits and making more trials available wherever you live.

As our regional lead for PPIE I’m very proud of the variety of opportunities we have to #BePartofResearch across the North East and North Cumbria. Patients are at the heart of everything we do, so we have patient focus groups to advise researchers on the type of research that is important to them, and to ensure trial protocols are as convenient and accessible as possible. Our patient and public research champions are there to encourage and support anyone wanting to find out more about research and we have lay representatives on our decision making committees to ensure that the patient voice is always represented.

Dr Joy Allen is Senior Clinical Test Evaluation Methodologist at Newcastle MIC.

From the beginning of the pandemic, NIHR repurposed researchers with skills relevant to the response.  The Newcastle MIC team have skills in evidence synthesis, designing of clinical studies, and evaluating diagnostics.  We quickly moved towards COVID research and immediately helped clinicians to synthesise the large amount of evidence that was coming out of other countries to inform their practice. In this very small way, we felt we could really help the frontline staff which was an honour and a privilege. 

We became more nimble and agile as we needed to speed up and work out what was required to pragmatically make decisions on the frontline. We have moved to remote working; our team has expanded, and we have gained a lot of additional skills.  This has enabled us to be more productive, focused and deliver research at a much faster pace. 

Video calls have made it much easier to collaborate with lots of researchers across the UK.  We have worked with partners including other MICs to help evaluate new COVID diagnostics.  This helped the government identify which tests could be beneficial in different settings and scenarios. I think everyone at the time just wanted to do what they could to help the NHS. The team has been amazing. They adapted very quickly and there was a real combined motivation to do the work we were doing.

We have developed stronger networks with organisations such as the Medicines and Healthcare products Regulatory Agency (MHRA), The National Institute for Health and Care Excellence (NICE) and the other MICs.  This has been very beneficial and has meant the work we have delivered has had a real impact.  Through strengthening these connections during COVID we are now working with these organisations on other projects as well.

I think the research community has become more connected during the pandemic through larger use of social media and pre-print severs.  This has been an effective way of sharing the latest information and research before it has gone through the peer-review process.   

It has also been more accessible for us to deliver bigger pieces of clinical research to tight deadlines as the approval processes for setting up clinical studies have also been faster. 

I feel we are in a hugely privileged position as we work directly with the people developing innovations to help improve care in the NHS for patients.  The end users for diagnostics are patients so it is vital that they are involved in all aspects of our work.  There are lots of different ways people can get involved in our work from participating in clinical studies, to co-designing specific projects and influencing our research priorities as a member of our insight panel for patients, public and carers.  Through working with us the public can make sure that the tests we work on are optimally developed and designed for the people that are going to use them.  Otherwise, the tests will not work and will not be used in practice.  Having the patient voice advocating and telling us what we should work on is crucial and gives us that motivation that we are doing something that really does have impact and will improve people's lives. 

Right now, research is a key part of how we develop and how we get out of this pandemic.  Patients have a huge role in that.  The best way to support the NHS now is to take part in and #BePartofResearch. 

And finally we hear from Kathryn Walker, one of the Research Nurses at Newcastle CRF.

My work has varied drastically over the past year. During wave one of the pandemic I was redeployed to a non-clinical role with the NUTH Pandemic Research Team. This was a totally new way of working; I was aligned with the Clinical Trial Coordinators in study set-up, setting up the trials from a clinical perspective. This allowed the patient-facing nurses on the pandemic team to concentrate wholly on recruiting patients and conducting study visits, streamlining the system during a very busy time.

On return to my normal role as Clinical Research Nurse in CARU, all of my studies had been paused due to the pandemic. As we started the massive task of restarting our studies and recommencing set-up on new studies, it became apparent that with the pandemic restrictions came new ways of working. Our research support staff were mainly home-based, making us more reliant on emails rather than in-person collaborations. On our newly restarted studies; telemedicine and remote visits became the new norm, whilst patient visits in person to the unit became less common. Recruitment became a challenge as many clinics were run remotely, so excellent communication between the research and clinical teams became essential as we relied on those conducting the clinic visits to promote the research.

Looking back over the past year it is very apparent that the COVID-19 pandemic has impacted clinical research in a number of ways, however we have proven that through hard work, adaptability and excellent teamwork we can push forward and do the best for our patients.

The COVID-19 pandemic has made it necessary to make changes to how we deliver research. Many of my follow-up visits are currently conducted remotely via telephone, and many of the studies currently being set up will be like this too. We are finding some new studies are using central pharmacies which will send study medications directly to the patients home so that they don’t have to attend the unit unnecessarily during the pandemic. Many of our support staff are now working flexibly and partially from home, which has made it necessary to develop new ways of working within our own team. Most notable is the change in delivering research in the clinical area - with mandated PPE, social distancing, and patients attending alone whenever possible to reduce any risks.

There are so many opportunities to participate in research in Newcastle, we are extremely research-active! Whether it is for a specific medical condition or as a healthy volunteer we are always recruiting to new studies. If you are interested, speak to your doctor or volunteer at the #BePartofResearch section of the NIHR website where you can look up studies in your local area.

Thank you to all of the colleagues who have shared their COVID research journey with us.

If you want to find out more about clinical research then you can visit www.bepartofresearch.co.uk

Other NIHR infrastructure in the region includes the Applied Research Collaboration North East and North Cumbria, Innovation Observatory, Research Design Service North East and North Cumbria, School for Public Health Research, Policy Research Unit in Behavioural Science, Hazard Protection Research Unit in Chemical and Radiation Threats and Hazards and the Blood and Transplant Research Unit in organ Donation and Transplantation.