Clinical research is regarded as an optimal standard of care and is integral to recommendations for a modern, high-quality cancer service in England (Independent Cancer Taskforce, 2015). The standards required to conduct clinical research are regarded as ‘a massive lever for quality improvement’ (Richards et al, 2018: 90). Clinical trials are a major type of clinical research study. Clinical trial participation that was supported by a national research infrastructure has been linked to improved outcomes in 209 000 patients (Richards et al, 2018: 90).
Patient awareness of clinical trials
The success of clinical trials is dependent on patient awareness (Fern et al, 2014), which in turn is dependent on health professionals, particularly nurses, raising patients' awareness of clinical trials. Evidence suggests that there is much to be done to improve patients' awareness of clinical trials; the National Cancer Patient Experience Survey for 2017 identified that only 31% of patients said that taking part in cancer research had been discussed with them (Quality Health, 2017). This highlights the need for more engagement in conversations with patients about clinical research.
Supporting access to clinical trials
Practical and logistical factors, particularly lack of time, are major barriers to nurses supporting access and recruitment to clinical trials (Elliott et al, 2017). Another barrier to nurses facilitating patients' awareness of, and access to, clinical trials is the nurses' perception of the potential burden of the trial on the patient. Ulrich et al (2012) considered the attitudes of 455 nurses regarding cancer clinical trials and willingness to discuss research participation with patients. Some nurses were concerned about randomisation, patient understanding of the trial and patient burden; these nurses were less willing to discuss clinical trials with patients. Nurses who thought clinical trials were useful were more comfortable discussing them with patients. An additional barrier is that most nurses who do not have a dedicated research role do not receive training about good clinical practice. Nurses' lack of information about clinical trials and poor teamwork with research teams have also been reported as barriers to communicating with patients about trial participation (French and Stavropoulou, 2016).
One model proposed to overcome potential barriers to trial access is the joint clinical research nurse/clinical nurse specialist role. This joint role was discussed at a round-table event supported by the Royal College of Nursing (RCN) and Cancer Research UK, which brought together clinical nurse specialists and clinical research nurses to develop recommendations for collaborative working to increase opportunities for patients to participate in clinical trials (Thornton, 2017).
Pearce et al (2018), however, identified the importance of the patient's perception of the clinical nurse specialist being distinct from the role of the research team. The reason for this in young people with cancer was that the young people valued the neutrality of the clinical nurse specialist when making decisions about participating in a clinical trial. This might be an age-specific finding, but it is important to consider patients' perceptions of nursing roles when new models of care are being proposed.
Teamworking to improve patients' experiences and outcomes
Clinical trials are delivered by multidisciplinary teams, so it is important to consider the role of the nurse as a member of the multidisciplinary team and the roles of other team members that can support nursing activity, such as research practitioners. Clinical nurse specialists who work closely with trials teams and clinical research nurses who work closely with clinical teams can enhance the patient experience and improve clinical trial participation. French and Stavropoulou (2016) explored clinical nurse specialists' perceptions of barriers and facilitators to inviting patients to clinical trials. Five main themes were identified: assessing patient eligibility, team work, perceived value of the research, logistics of the invitation process, and understanding of the study. The main facilitating factors were the clinical nurse specialists' attitudes, skills and experience of clinical research, which were influenced by a strong local research culture and close working relationships between the research and clinical teams. Similarly, close working relationships between clinical nurse specialists and clinical research nurses were found to improve communication about clinical trial participation with young patients with cancer (Lavender et al, 2019).
Another model that might, therefore, optimise patient access to, and experience of, clinical trials is one of shared care, where clinical nurse specialists and clinical research nurses work together to ensure that the patient pathway is streamlined (Thornton, 2017). There is a consensus that involving the clinical nurse specialist in clinical trial discussions with patients is beneficial in raising awareness of clinical trials, and clinical nurse specialists can provide support to patients contemplating clinical trial participation. This would arguably improve patients' experiences of clinical trial participation. Improved teamworking between clinical teams and clinical trials teams, facilitated by close working relationships between clinical research nurses and clinical nurse specialists, might also improve nurses' experience of their practice environment, resulting in shared learning and increased retention of nurses with specialist knowledge, skills and experience.
The role of the clinical research nurse: a nursing specialty
A key role of clinical research nurses internationally is to recruit patients to clinical research, ensuring the successful conduct of clinical trials (Green, 2011; Catania et al, 2012; Wilkes et al, 2012; Ness and Royce, 2017). In addition to the nursing roles of clinical practice, maintaining patient safety and ensuring continuity of care, the role of the research nurse includes specialist aspects of care, such as study coordination and management and contribution to the generation of clinical evidence.
In order to undertake this role, nurses need advanced communication skills to provide information and support to patients and their families (Pearce et al, 2018; Lavender et al, 2019). Additional roles of clinical research nurses vary, but mostly include (Hastings et al, 2012):
Education and development for clinical research nurses
Clinically relevant, specialist education and professional development are essential in supporting research nurses who work in rapidly evolving landscapes of cancer services, where cancer clinical trials are becoming increasingly complex. There is a number of face-to-face, online and blended courses (mostly offered at postgraduate level), that provide education about how clinical trials are designed, planned and managed. There are also courses about cancer treatments and care, but these do not fully meet the specific learning needs of this essential nursing workforce. Furthermore, nurses working in cancer clinical trials do not have an equivalent framework to the RCN and UK Oncology Nursing Society (UKONS) (2017)Career and Education Framework for Cancer Nursing.
Cancer Research UK recognised the specific learning needs of research nurses working in cancer trials and in March 2018 launched the Excellence in Research Programme (cruk.org/excellenceinresearch). The launch at the Francis Crick Institute saw more than 80 research nurses working in cancer come together from across the UK, and many commented on the valuable opportunity to attend such an event dedicated to their role. Core to the programme is an online hub linking learning resources, such as massive online open courses, and educational content that is useful for all cancer nurses, such as the online course ‘Demystifying targeted cancer treatments’ (po.st/crukcourse). The programme also provides a platform for professional cohort development through peer-to-peer networking. A meeting toolkit is currently being piloted with the goal of making shared learning easier, and more bite-sized learning resources and another dedicated networking event are planned. In summary, the programme aims to support the development and raise the profile of clinical research nurses and increase awareness of their role across the wider clinical setting, particularly among other cancer nurses. To facilitate this, Cancer Research UK is keen to work closely with other organisations, such as the National Institute for Health Research and the UK Clinical Research Facility Network, to champion the role of clinical research nurses. Doing so might facilitate closer working relationships between clinical and research teams and enhance the patient experience of cancer clinical trials.
Conclusion
With an increasing portfolio of complex cancer trials, there is an ever-growing demand for the specialist role of clinical research nurses working in cancer. The role requires high-level communication skills to support and care for patients and their families, for example processing information and making decisions about participation and treatment in clinical trials soon after a cancer diagnosis.
There are opportunities, such as the Cancer Research UK Excellence in Research Programme, for clinical research nurses to develop specialist knowledge and skills, have access to peer-to-peer learning and support, and share best practice. Given the importance of improving health interventions, and the benefit to patients of clinical trials, nurses working in all areas of practice should support patient access to clinical trials. There is opportunity for clinical research nurses and cancer nurse specialists to work together more closely to improve inter-professional communication, and in so doing improve patient experiences and outcomes.