Clinical trials are well recognized as critical steps in the evaluation of new treatments and health care interventions (Machin & Fayers, 2010). Although North America and Europe have the largest regional trials activity, clinical research is increasingly global, with rapid growth and expansion in recent years in Asia and South America (Hastings, Fisher, McCabe, & The National Clinical Research Nursing Consortium, 2012). Nurses in particular are sought for clinical research roles because of their education and background, clinical nursing experience, and interprofessional and patient communication skills (Kenkre & Foxcroft, 2001; Mueller, 2001; Spilsbury et al., 2008). As clinical trials activity has increased globally, demand for clinical trials nursing roles across clinical settings has also increased. Nonetheless, the clinical trials nursing work force has been described in the literature as “hidden” (Hill & MacArthur, 2006) and characterized by role isolation. Efforts to define clinical research nursing as a specialty practice are recent (Bird & Kirshbaum, 2005; Castro et al., 2011). In this article, the term “clinical trials nurse” refers to a role that is also called “research nurse coordinator” in the role delineation study undertaken as part of the National Institutes of Health Clinical Research Nursing 2010 initiative (Bevans et al., 2011).
The Educational and Career Pathway for Clinical Trials Nurses: An International Perspective
There is widespread recognition that educational and training opportunities for nurses who are pursuing a career in clinical trials are inadequate (Hill & MacArthur, 2006; Mori, Mullen, & Hill, 2007; Rickard, Roberts, Foote, & McGrail, 2007). Preparation is frequently obtained through extensive “on-the-job” training, supplemented by short professional development courses offered through commercial training organizations or research centers and institutes (National Council for the Professional Development of Nursing and Midwifery, 2008; United Kingdom Clinical Research Collaboration, 2007). Organization-specific training was the most commonly reported type of training or education in clinical research for expert U.S.-based nurses working in clinical research (Castro et al., 2011). Clinical trials nurses commonly receive trial-specific training at investigator meetings facilitated by sponsors (led by pharmaceutical or research groups) in the operational aspects of a particular protocol and compliance with Good Clinical Practice guidelines (International Conference on Harmonisation, 2012). In more recent years, a small number of postgraduate courses that cover clinical trials within the course curriculum have become available; however, few programs have been developed for nurses specializing in a clinical trials nursing role.
Little is actually known of the educational, training, and professional background of clinical trials nurses, despite the reported increase in the number of nurses employed in dedicated clinical trials positions (National Council for the Professional Development of Nursing and Midwifery, 2008). Furthermore, the career pathway for clinical trials nurses is perceived as unclear (United Kingdom Clinical Research Collaboration, 2007), compounded by reports of inconsistent remuneration, insecure employment arrangements, and professional isolation (Hill & MacArthur, 2006). Variation in remuneration across coordinator roles and a limited career pathway were sources of dissatisfaction for research coordinators working in intensive care units in Australia and New Zealand (Rickard et al., 2007; Roberts, Eastwood, Raunow, Howe, & Rickard, 2011a, 2011b).
Nearly half (43%) of participants in a survey of clinical research nurses who were working in pediatric oncology in North America found role ambiguity stressful (Nagel, Gender, & Bonner, 2010). Unclear role definition also complicates the clear identification of the clinical trials nursing work force, including accurate estimates of the number of clinical trials nurses, with implications for work force planning as well as recognition of the clinical trials nurse as a specialty nursing role (National Council for the Professional Development of Nursing and Midwifery, 2008).
The Educational and Career Pathway for Clinical Trials Nurses: An Australian Perspective
In Australia, no precise data are collected on whether a nurse specifically works in a clinical trials role (Australian Institute of Health and Welfare, 2009). Although several disease area specialty groups exist, there is no national professional body representing clinical trials nurses in Australia. Available data on the employment profile of nurses in Australia indicate that registered nurses working in the role of “researcher” in Australia comprise approximately 1% of the overall nursing work force (Australian Institute of Health and Welfare, 2009). Because the type of research undertaken is not specified, it is likely that clinical trials nurses are a “hidden” component within this category.
Nursing employment conditions in Australia are mainly regulated by government bodies at both the federal and state levels (Australian Nursing Federation, 2009). Nursing classifications vary between states and between public and private health care settings (Australian Nursing Federation, 2009). There is no national nursing classification for nurses in clinical trials nurse positions in Australia, although some organizations and institutions have attempted to recognize nurses working in clinical trials according to a particular classification or pay scale.
A cross-sectional survey conducted in late 2009 provided a profile of the educational background and employment status of clinical trials nurses working in cancer clinical trials in Australia. The survey was conducted to gain a better understanding of the educational and training needs of clinical trials nurses in Australia. A 48-item questionnaire was designed and included questions on demographics, nursing experience and educational history, and clinical trials experience and training. The questionnaire included six clinical trials knowledge subscales with 33 items and seven clinical trials skills subscales. It addressed the perceived importance of knowledge and skills, level of interest in undertaking postgraduate education in clinical trials, barriers to undertaking postgraduate education, and preferred modes of learning, and it also allowed for qualitative comments. Participants completed self-rated knowledge and skills scores on a five-point Likert scale that ranged from 1 to 5. Results of reliability and convergent/divergent validity testing as well as scaling assumptions of the questionnaire were reported elsewhere, along with summary information on the participants (Scott, White, Johnson, & Roydhouse, 2012).
Participants included registered nurses employed in a clinical trials capacity at cancer centers and hematology units throughout Australia. Nurses were invited by e-mail to complete an anonymous online survey. The total number of nurses working in clinical trials in Australia is unknown, and there is currently no distinct national professional organization. A snowball sampling technique was employed, whereby an e-mail invitation to participate was distributed by permission through two nursing organizations in the fields of cancer and hematology. Descriptive statistics (frequency, proportion, mean score, and standard deviation) were calculated using SPSS, version 18.0, and Microsoft Excel 2007.
Participants had extensive nursing experience (mean 19 [SD = 9] years as registered nurses and 5 [SD = 5] years as clinical trials nurses), but highly varied employment status and primary job titles (Table 1). Of note, only 13% held management positions, with the titles “trials manager,” “research manager,” or “operations manager” most commonly reported.
Table 1: Experience and Employment Status of Australian Cancer Clinical Trials Nurses (N = 61)
Of 61 clinical trials nurse respondents, 90% were female, with a mean age of 43 (SD = 9) years. Most participants obtained their primary nursing qualifications with a bachelor of nursing degree (51%) (Table 2), and 42 respondents (69%) held postgraduate qualifications. Only three participants held qualifications specific to clinical trials. A majority (n = 42; 69%) had attended at least one short or professional development course related to clinical trials (e.g., clinical trials research methods, Good Clinical Practice) in the past 3 years (Table 2). Participants expressed a high level of interest in undertaking postgraduate education in clinical trials, with 61% indicating “yes,” 33% indicating “perhaps,” and only 6% indicating “no” when asked, “Would you be interested in undertaking postgraduate studies in clinical trials?” However, several significant barriers to undertaking postgraduate education were noted; the three most common were cost (n = 47; 92%), insufficient time (n = 37; 73%), and lack of clarity of the effect of such education on career advancement or promotional opportunities (n = 21; 41%) (Figure).
Table 2: Educational Background and Clinical Trials Training of Australian Cancer Clinical Trials Nurses (N = 61)
Figure. Barriers to undertaking postgraduate education in clinical trials research perceived by Australian cancer clinical trials nurses (n = 51). Participants could indicate more than one category.
Advancing the Educational and Career Pathway for Clinical Trials Nurses
Australian clinical trials nurses do not have trial-specific postgraduate qualifications, even though most survey participants reported interest in attaining these qualifications. The barriers identified in this study, predominantly the high cost of postgraduate study, insufficient time to study, and the defining problem of an unclear career pathway, should be considered and addressed by employers, nursing organizations, educators, and funding organizations. A range of strategies, including postgraduate studies incorporating academic achievement alongside acquisition of clinical skills, have been noted as important for addressing the specific educational and training needs of clinical trials nurses (United Kingdom Clinical Research Collaboration, 2007). Certification of clinical trials education and training has also been proposed, particularly as a means of attaining professional standards (Kenkre & Foxcroft, 2001; Mori et al., 2007). Similar plans have been introduced by some organizations, including the Society of Clinical Research Associates (2012) in the United States. No such program formally exists or is mandated in Australia, although individual clinical trials nurses may voluntarily undertake training that includes certification.
Only three respondents in the Australian survey held qualifications specific to clinical trials, consistent with recent findings from a survey of clinical trials nurses in Italy in which a majority of respondents lacked formal academic education in clinical research (Catania et al., 2012). It is expected that nurses who undertake postgraduate studies in clinical trials will acquire a higher level of knowledge and skills that will enable them to become advanced “practitioners” in clinical research (Scott et al., 2012). Making available more accessible specialized education is an important step toward improved career advancement for clinical trials nurses, in conjunction with other strategies that lead to clearer professional role recognition. This is also important given the wide variation in employment status and thus likely variation in remuneration levels reported in this survey. In the United Kingdom, clinical research nurse grading scales have been introduced (Kenkre & Foxcroft, 2001) and a national banding system for nursing staff has led to greater consistency in the grading of nurses who work in dedicated clinical research roles (National Council for the Professional Development of Nursing and Midwifery, 2008). The experience in the United Kingdom suggests that such initiatives can lead to a clearer career pathway for clinical trials nurses within the broader nursing profession.
To address the current inadequate educational and career pathway for Australian clinical trials nurses, the following initiatives are therefore proposed:
Formal postgraduate education specific to clinical trials research.
Greater consistency in employment status and job titles.
Clearer career progression.
Implementing these initiatives entails further detailed investigation and consultation with a broad spectrum of stakeholders. These should include professional nursing organizations, major health care employers, and academic nursing institutions to enhance the understanding and recognition of the clinical trials nurse as a distinct and specialized nursing role (Bird & Kirshbaum, 2005; Mueller, 2001; Raja-Jones, 2002; Scott et al., 2012).
In conclusion, findings from a survey of nurses working in cancer clinical trials research in Australia showed that despite participants’ extensive nursing experience and postgraduate qualifications, formal educational preparation in clinical trials was inadequate. Interest in pursuing postgraduate education specific to clinical trials was reportedly high; however, several barriers were identified, including cost, time, and unclear benefit for career advancement. Job titles varied substantially, which is indicative of an unclear employment pathway. The survey findings suggest that a range of initiatives is needed to advance the educational and career pathway for clinical trials nurses.
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Experience and Employment Status of Australian Cancer Clinical Trials Nurses (N = 61)
|Mean years as registered nurse (SD)||19 (9)|
|Professional employment status|
| Registered nurse||21 (34)|
| Clinical nurse specialist||10 (16)|
| Clinical nurse consultant||13 (21)|
| Nursing unit manager||1 (2)|
| Other||16 (26)|
|Primary job title|
| Clinical trials nurse or clinical research nurse or research nurse||22 (36)|
| Nurse||14 (23)|
| Clinical trials coordinator or study coordinator||8 (13)|
| Manager (trials or research)||6 (10)|
| Clinical nurse (or specialty specific [e.g., breast care nurse])||3 (5)|
| Clinical nurse specialist or clinical nurse consultant||8 (13)|
Educational Background and Clinical Trials Training of Australian Cancer Clinical Trials Nurses (N = 61)
|Primary nursing qualifications|
| Hospital training||24 (39)|
| Nursing degree||31 (51)|
| Nursing degree (Honours)||6 (10)|
|Highest level of postgraduate qualification (n = 42) b|
| Graduate certificate||15 (36)|
| Graduate diploma||17 (40)|
| Master’s degree||9 (21)|
| Qualifications not tertiary level||1 (2)|
|Area of postgraduate qualificationsc|
| Cancer/hematology nursing||24|
| Other nursing specialties (e.g., critical care)||11|
| Clinical nursing/clinical practice||4|
| Clinical trials/research related||3|
| Nursing research related||2|
| Other health-related postgraduate qualifications (e.g., public health)||12|
| Other non-health-related postgraduate qualifications||6|
|Clinical trials training (past 3 years): number of courses taken|
| No courses||19 (31)|
| 1 course||21 (34)|
| 2 courses||11 (18)|
| 3 courses||5 (8)|
| 4 courses||3 (5)|
| 5 courses||2 (3)|
|Clinical trials training (past 3 years): type of courses takend|
| Clinical trials research methods||9 (15)|
| Good Clinical Practice||29 (48)|
| Project management||9 (15)|
| Other (includes courses that may combine several types)||16 (26)|
| Data management||4 (7)|