Discussion
The current study was carried out to gather information relating to the training and roles of research nurses who conduct paediatric clinical trials across Europe. A questionnaire-based survey was proposed and executed by Enpr-EMA, with responses gathered from 341 respondents, encompassing 45 different disease specialties and 20 European countries. As there was no explicit sampling frame, in terms of a defined list of numbers of research nurses in the networks and centres who received the questionnaire to complete, it was not possible to address the extent of non-response bias and this represents an accepted limitation of the study. Similarly, while national and disease specialty networks of paediatric research nurses were identified through Enpr-EMA networks and the identification of appropriate European groups through internet searches, many lead network contacts were not research nurses and wider circulation of the study information and link to the survey may not always have been prioritised.
Results generated from the questionnaire were generally encouraging, with 86% of respondents either fully satisfied with the level of training received, or satisfied that they were appropriately trained for the majority of tasks that they carried out. Indeed, a healthy percentage of respondents had either completed formal postbachelor education or training programmes or obtained more focused training in key areas, commonly provided by sponsors or pharmaceutical companies. However, 67% of respondents also felt that they would benefit from additional training, with a wide range of areas highlighted where training would be most beneficial. The most common areas for additional training reflected the increased complexities of modern day clinical trials and increasing requirement for research nurses to possess a wide range of skill sets.2 3 These included clinical trial set-up and management, IT skills, pharmacovigilance, CRF data entry and laboratory skills training. A number of respondents highlighted the challenges of keeping up to date with frequent changes to clinical trial practices relating to ever increasing GCP regulations.
In terms of how research nurses obtain training, 54% of respondents received their initial training online, when they first took up post, and 68% received training updates online. These figures highlight marked increases in online nurse training observed over the past 20 years, largely due to its convenience and flexibility. Online training can help to avoid problems relating to intensive workloads and working shifts, which could provide barriers to research nurses attending scheduled training sessions. In this respect, many studies have reported positive outcomes from online nurse training, with learning outcomes comparable or even improved as compared with face-to-face training events.8
One interesting point raised by several participants, related to the expectation that they would gain relevant experience through ‘on the job’ training. This theory appears to be supported by the findings of the current study, with a clear relationship observed between length of time in post and level of training satisfaction reported. Several respondents highlighted the fact that they would have benefited from more training when they first started in post, at which time they were unaware of the training opportunities available. This may be particularly relevant to countries where higher levels of dissatisfaction were reported in terms of training received. For example, in some Nordic countries, more accessible research nurse training programmes have only relatively recently been developed, following studies highlighting a need for more relevant training to be made available.10 11 This represents an area that could be improved, through advertising and promotion of research nurse training events. The availability of induction packs for new research nurses, containing relevant information and useful links to networks where training is available, is commonplace in some countries and should be encouraged more widely. It is accepted that the role of the research nurse may differ significantly between countries and that the current survey, while relatively expansive in terms of the number of respondents and countries involved, did not include respondents from many other European countries.
Data generated from the current study highlight the integral role that research nurses play in the running of clinical trials in paediatric specialties,2 3 with significant numbers of participants being involved in various wide-ranging tasks. In terms of the practicalities of working in a clinical trial setting, high percentages of respondents were involved in taking patient consent, collection and processing of samples, patient training and the administration of IMPs. Despite relatively small numbers of respondents from individual countries, apparent differences were observed in the level of involvement in activities including administration of IMPs and taking consent. Such differences may reflect guidelines and philosophies within countries, with the role of taking consent being actively encouraged in the UK, but not being seen as an appropriate research nurse role in some European countries. Indeed, it is entirely feasible that while research nurses may feel comfortable in explaining clinical trials to patients and families, they may be less amenable to being responsible for the signing of consent forms. In this respect, it is important to understand that the appropriateness of research nurses taking on this responsibility may be related to the complexity of the particular clinical trial and the IMP involved. For research nurses working in environments where roles such as the taking of consent are encouraged, competency tools are commonly available to promote patient safety and may be included in research nurse induction packs referred to above.12
A key role absent from the activities of the vast majority of respondents related to the prescribing of IMPs, with only 3% of research nurses performing this role. For research nurses to prescribe medicines, including unlicensed and clinical trial drugs, they are required to have the appropriate qualifications.13 In the UK, registered nurses with a minimum of 3 years of clinical experience must undertake a recognised ‘Nursing and Midwife Council’ accredited prescribing course through a UK university. Other countries have their own research nurse qualifications, which may contrast in terms of the level of training involved and the prescribing responsibilities of the research nurse.14 15
While nurse prescribing in the UK and Europe has developed significantly over the past decade, with an estimated 19 000 nurse prescribers registered in the UK in 2014,16 this remains a remarkably underdeveloped area. Indeed, experience in the UK indicates that differences exist between individual centres and health authorities, in terms of whether or not research nurses are able to prescribe IMPs, even if the appropriate level of training is in place. Therefore, the reported low numbers of research nurses responsible for prescribing IMPs may reflect local legislation, as opposed to a lack of desire for nurses to be involved in this area. Benefits of research nurse prescribing in the UK have been widely reported,17 18 and may represent an area where improvements could be made to the efficiency of running paediatric clinical trials. An increase in level of nurse prescribing would seem to represent a sensible way to optimise the skills and expertise of all health professionals working in increasingly stretched healthcare systems.19 It is unclear whether or not the observed increased research nurse prescribing rates in countries such as Norway and Switzerland reflects a real difference, possibly related to more accessible training and accreditation in these countries, as the numbers of respondents from the majority of countries was small. Similarly, differences highlighted between countries in the percentages of research nurses actively involved in taking patient consent and the administration of IMPs should be interpreted with caution.