Features

Clinical trials: what does a research nurse do?

Roles that can change patient’s lives, from study coordinator to supporting participants

Roles that can change patients lives, from study co-ordinator to supporting participants

  • Nurses roles in testing and developing cutting edge treatments for through clinical trials, and how COVID-19 has changed the way they work
  • What you need to know to become a research nurse and how your career may develop
  • Leaders in clinical research explain how nurses become experts in their trials, guide patients through the process and support families along the way
Suriya Kirkpatrick manages the cancer trials team at Southmead Hospital Picture: Jon Rowley

Clinical trials stand at the cutting edge of healthcare, helping to advance medicines, products and procedures for the benefit of patients.

In the 14 years since the

...

Roles that can change patient’s lives, from study co-ordinator to supporting participants

  • Nurses’ roles in testing and developing cutting edge treatments for through clinical trials, and how COVID-19 has changed the way they work
  • What you need to know to become a research nurse and how your career may develop
  • Leaders in clinical research explain how nurses become experts in their trials, guide patients through the process and support families along the way
Suriya Kirkpatrick manages the cancer trials team at Southmead Hospital Picture: Jon Rowley

Clinical trials stand at the cutting edge of healthcare, helping to advance medicines, products and procedures for the benefit of patients.

In the 14 years since the National Institute for Health Research (NIHR) was set up in England, with equivalent bodies elsewhere in the UK, there has been a sharp increase in the number of nurses involved in running trials. But what exactly do these nurses do?

What is a clinical trial and how do you start planning for one?

We spoke to a number of the UK’s leading clinical research nurses to find out more about what’s involved in working in clinical trials.

The NIHR defines a clinical trial as a research project involving ‘two or more treatments in patients with a particular condition, or at risk of a condition, to help generate high quality evidence about which is the more effective treatment or preventative strategy’.

The treatment being investigated can be a medicinal product, a procedure, a device or another type of therapeutic intervention.

‘Essentially, there’s a research proposal, with a research question,’ says NIHR Clinical Research Network associate director of nursing and research delivery Sharon Barrett.

‘There will always be a research question. Then the lead researcher pulls together a protocol – a step-by-step process to answer that question – including information on the populations being targeted, how they’ll be screened and identified, and what you’re going to do.

‘Once the protocol is in place, the trial needs ethical or governance approval from a local ethics committee.’

Then the work of recruiting patients begins.

Clinical trials include four main phases (see box).

Four phases of a clinical trial

Phase 1 of a clinical trial is the stage at which the treatment is confirmed to be safe on humans and that it broadly does what it is intended to do, the best dosage is established and the treatment is judged to be worth taking further.

Phase 2 involves researchers looking at how well the treatment works. They may be trialling it against another treatment or a placebo, possibly as a randomised controlled trial.

Phase 3 After analysing the results, they can move to phase 3, which involves a larger population, comparing the treatment against the standard treatment on offer and finding out more about how it affects patients’ quality of life. After this, the treatment may be licensed for use.

Phase 4 is when the researchers look more at side-effects, safety and the long-term risks and benefits of the treatment.

How is consent for participating in a clinical trial obtained?

Lauran O’Neill: ‘We’ve come up with new
ways of working’

In most cases, adult patients have to give consent themselves and must have capacity to do so. There are some exceptional circumstances – for instance, treatments specifically designed to treat accident victims.

There is also the option of ‘deferred consent’ in critical care treatments where patients are enrolled onto a study if all the professionals involved consider them eligible and the family’s consent will be sought later, ideally within 48 hours.

‘For more of our non-COVID studies, we are now able to recruit families in a deferred consent model, taking their consent at a later point,’ says senior research nurse Lauran O’Neill, of the critical care research team at Great Ormond Street Hospital in London.

Nurses have a crucial role in the research team, from recruiting patients onwards. Often the person coordinating the trial for the principal investigator (PI) is a research nurse.

Their responsibilities include drawing up protocols, submitting study proposals, explaining the trial to patients and recording and collecting data.

How does patient care figure within clinical trials?

Ben Hood: ‘‘Nurses become experts on
the research’ Picture: Barney Newman

Cancer Research UK senior research nurse for Newcastle Ben Hood says the charity’s nurses are part of delivering all the treatments and monitor patients carefully.

‘They manage all the visits and are a point of contact for patients and their families. They ensure there is informed consent all the way through and that patients know they can change their mind at any point,’ says Mr Hood, who works at the Sir Bobby Robson Cancer Trials Research Centre at the Newcastle Freeman Hospital’s Northern Centre for Cancer Care.

‘They effectively become experts on the research trial because they are the person the patients are talking to, explaining the whole trial and the clinical pathway, and what it involves.

‘Families become quite invested in this process as well, so it’s important to support them too.’

Senior cancer research nurse and genomics practitioner Suriya Kirkpatrick says there are many options for nurses new to research.

‘I came in as a haematology research nurse, but within months I’d worked on studies in different tumour areas,’ says Ms Kirkpatrick, who is a based at Southmead Hospital, part of North Bristol NHS Trust.

‘As you go up the ladder, you have to make the decision as to whether you retain the clinical work or not, depending on the support and leadership you have’

Suriya Kirkpatrick, senior cancer research nurse and genomics practitioner, Southmead Hospital

‘A nursing background helps because you’re expected to be an expert in a variety of skills – the clinical ones like taking bloods and samples, but also the advanced skills of good history-taking, or being able to carry out a physical examination, as well as communication.

‘Historically, it was senior, more experienced nurses who came into this role, but now it’s being promoted as a career option in its own right. But I do think previous clinical experience is important.’

Is a trial a good option for patients not responding to other treatments?

From first trial to treatment takes at least five years and many treatments or procedures do not make it past the initial stages, especially those involving drugs, genes or stem cell work.

Surgical procedures are slightly different as it is easier to see if they have worked. Finding funding can take time too.

Whether taking part in a clinical trial is a good option for patients not responding to other treatments is far from guaranteed. In fact, patients on many trials need to understand that they may not be given the drug being trialled.

But, says NIHR PhD student and Queen’s Nurse Ben Bowers, they will be getting the gold standard of care, whether that is the trial drug or the standard treatment.

‘Often you’ll actually get more care than you would have otherwise,’ he says.

But he adds: ‘It can be upsetting if patients have high hopes of taking part in an oncology or palliative drug treatment study and they aren’t suitable. It’s a difficult one to navigate because there are no guarantees taking part will help give them a better outcome.’

Are clinical trials only relevant to secondary care?

Not at all. Mary Fifield is one of a number of clinical research nurses working in primary care at Heart of Bath Medical Partnership.

‘I work with a research study coordinator, working with GPs who are the PIs. The difference from secondary care is that these patients – for instance, patients with diabetes – wouldn’t normally go into hospital at all.

‘We’re doing a paediatric immunisation study and we’re integrated with the nursing team that normally gives the immunisations. It’s more normalised than going into hospital – which is particularly pertinent now.’

Research in the COVID-19 era

Research via Zoom: COVID-19 has
prompted new ways of working
Picture: iStock

COVID-19 has affected research in different ways.

Many trials were put on hold, then restarted, and some nurses are concerned that participants may now be less willing to go into a GP surgery or hospital.

On the other hand, senior research nurse Lauran O’Neill says: ‘We’ve also come up with new ways of working. We’re super-efficient at getting studies up and running, and can roll them out much more quickly.

‘Little things like Zoom meetings make it all much more efficient. There are ways of working that will stay with us.’

Importantly, the enormous number of studies into COVID-19 and other aspects of public health have also brought the value of research into sharp relief.

‘One colleague told me that, at her hospital, generic nursing staff are being redeployed into research rather than the other way round,’ says Sharon Barrett of the National Institute for Health Research.

‘More people want to find out about research and clinical research nursing.’

Are all research nurses specialists in one area?

Research nurses may work in different specialties as their careers progress, or they may specialise. Despite a shortage of ophthalmic nurses, Moorfields Eye Hospital NHS Foundation Trust now has a pool of potential research nurses available to work on the research conducted at the hospital.

‘The skills are broadly convertible, in terms of what research skills you need. The difference is in terms of specialty,’ says Moorfields head of research nursing Roxanne Crosby-Nwaobi.

‘I wouldn’t expect a cardiac research nurse to know about the eye and vision, to know about the safety parameters and what to notice. You need to be quite au fait with your specialty. All of our nurses are now postgraduate, trained up to master’s level, and I have a PhD.’

Working in research: ‘what we’re doing will change people’s lives’

Diane Murray: ‘Managing expectations
can be difficult’

Diane Murray is employed by the Cystic Fibrosis Trust and NHS Glasgow.

‘I qualified in 2004, came to Glasgow and worked in neurosurgery. Then I did a master’s and a job in research came up. I’ve worked in this area for six years now,’ she says.

‘The first year it was a rotational post, working across a range of specialties – a taster year – then a band 6 post came up in the respiratory team. For two years I worked mostly in asthma and chronic obstructive pulmonary disease, then this new co-funded post came up, to ensure that cystic fibrosis (CF) patients around the UK have better access to clinical trials.

‘I set up the trials, dealing with the sponsors and outside agents, the approvals and ethics processes. Once it’s up and running I’m assessing patients to see whether the trial drug is making a difference. I also go into clinics to talk about research and ask if anyone is interested in particular trials that are going on.

‘I’m principally working on the new CFTR [CF transmembrane conductance regulator] modulator, which manufactures the proteins that people with CF lack. It’s not yet licensed within the UK but, as and when it is, it’ll revolutionise life for people with CF. The main challenge is that we may only have four or five slots, whereas we have around 200 patients who would desperately like to trial it.

‘Managing people’s expectations can be difficult. On the other hand, it’s incredibly exciting being in this job at this point. I don’t think I’ll ever have a job like it again.’

Are there good chances of career progression as a research nurse?

Research nurses learn specific skills and career options are opening up. But initially all that qualified individuals need is a genuine interest in research, says Dr Barrett.

‘You can start as a band 5, supporting research, taking bloods and doing ECGs [electrocardiograms]. As you become more senior you gain skills on the job, taking a role in developing and supporting protocols, writing ethics applications and so on,’ she says.

There are also nurse researchers who conduct their own research, like Queen’s Nurse Mr Bowers and a number of Dr Crosby-Nwaobi’s team at Moorfields.

However, Ms Kirkpatrick points out that although it is possible to combine the two roles – she works one day a week as a research associate at the University of Bristol and the other four days in Southmead Hospital – there are limited opportunities for career progression on this basis.

‘As you go up the ladder, you have to make the decision as to whether you retain the clinical work or not, depending on the support and leadership you have access to.’

Would research nurses recommend the role to others?

Cancer Research UK’s Mr Hood, who has been in clinical research for almost 13 years, describes it as one of the most rewarding areas in which to work, especially the area of cancer treatments.

‘The patients we meet and care for are incredible. In many cases they are giving up what precious time they have, knowing that the research may not benefit them, but they do it to aid future generations of patients.’

Ms Kirkpatrick adds: ‘It’s fascinating. It’s so rewarding. I’ve never been this happy with my job.’


Radhika Holmström is a health journalist

Want to read more?

Subscribe for unlimited access

Enjoy 1 month's access for £1 and get:

  • Full access to nursing standard.com and the Nursing Standard app
  • Monthly digital edition
  • RCNi Portfolio and interactive CPD quizzes
  • RCNi Learning with 200+ evidence-based modules
  • 10 articles a month from any other RCNi journal

This article is not available as part of an institutional subscription. Why is this?

Jobs