The role and potential contribution of clinical research nurses to clinical trials

Spilsbury, Karen; Petherick, Emily; Cullum, Nicky; Nelson, E Andrea; Nixon, Jane; Mason, Su

doi:10.1111/j.1365-2702.2006.01872.x

Cited by 97 publications

(132 citation statements)

References 19 publications

(32 reference statements)

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“…Many studies (23/35) explored recruitment issues within the context of a single RCT [13,[23][24][25][30][31][32][33][36][37][38][39][40]42,44,[46][47][48][51][52][53][54]56], whilst eight provided a synthesis of results from multiple RCTs [26][27][28]41,45,49,50,55]. Four studies sampled healthcare professionals who recruited to RCTs generally, rather than a specific trial [29,34,35,43].…”

Section: Summary Of Included Papersmentioning

confidence: 99%

“…Recruiters were from urological cancer trials [13,23,25,27,28,40,41,44,55], other cancer trials [24,27,28,32,35,40,44,49,50,52,54,55], mental health [27,28,39,46,50,55], orthopaedics [31,33,38,49,56], diabetes [36,47], vascular surgery [40,49], peripartum trials [37,53], HIV [30], smoking cessation [42], and pressure area care [51]. The majority of studies (32/35) focused on RCTs that were conducted in the UK [13,[24][25][26][27][28][29][31][32]…”

Section: Summary Of Included Papersmentioning

confidence: 99%

“…The majority of studies (32/35) focused on RCTs that were conducted in the UK [13,[24][25][26][27][28][29][31][32][33][34][35][36][37][38][39][40][41][43][44][45][46][47][48][49][50][51][52][53][54][55][56].…”

Section: Summary Of Included Papersmentioning

confidence: 99%

“…Studies consisted mostly of interviews or focus groups with those involved in recruitment to RCTs [13,[23][24][25][26][27][28][29][30][31][32][33][34][35][36][37]39,[42][43][44][46][47][48][49][50][51][52][53][54][55][56], sometimes alongside interviews with patients who had been offered the opportunity to join the trial [23][24][25][26]33,37]. Several studies audio recorded consultations where recruiters discussed the RCT with eligible patients [13,[24][25][26]31,32,38,40,41,44,45,49,…”

Section: Summary Of Included Papersmentioning

confidence: 99%

“…For instance, recruiters described how intellectual challenges and professional kudos were incentives to participate in RCTs [30,43]. Many felt that participation in trials was beneficial in that it provided patients with access to novel treatments [29,30,34,39,43,51], gave patients hope [29,30], and monitored participants closely [30,39,43]. The majority of studies used interviews to understand recruiters' perceptions of factors that impacted upon recruitment to RCTs.…”

Section: Exploring Facilitators and Barriers To Recruitmentmentioning

confidence: 99%

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Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

et al. 2017

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Context: The importance of evidence from randomised trials is now widely recognised, although recruitment is often difficult. Qualitative research has shown promise in identifying the key barriers to recruitment, and interventions have been developed to reduce organisational difficulties and support clinicians undertaking recruitment. Objective: This article provides an introduction to qualitative research techniques and explains how this approach can be used to understand-and subsequently improverecruitment and informed consent within a range of clinical trials. Evidence acquisition: A literature search was performed using Medline, Embase, and CINAHL. All studies with qualitative research methods that focused on the recruitment activity of clinicians were included in the review. Evidence synthesis: The majority of studies reported that organisational difficulties and lack of time for clinical staff were key barriers to recruitment. However, a synthesis of qualitative studies highlighted the intellectual and emotional challenges that arise when combining research with clinical roles, particularly in relation to equipoise and patient eligibility. To support recruiters to become more comfortable with the design and principles of randomised controlled trials, interventions have been developed, including the QuinteT Recruitment Intervention, which comprises in-depth investigation of recruitment obstacles in real time, followed by implementation of tailored strategies to address these challenges as the trial proceeds. Conclusions: Qualitative research can provide important insights into the complexities of recruitment to trials and inform the development of interventions, and provide support and training initiatives as required. Investigators should consider implementing such methods in trials expected to be challenging or recruiting below target. Patient summary: Qualitative research is a term used to describe a range of methods that can be implemented to understand participants' perspectives and behaviours. Data are gathered from interviews, focus groups, or observations. In this review, we demonstrate how this approach can be used to understand-and improve-recruitment to clinical trials. Taken together, our review suggests that healthcare professionals can find recruiting to trials challenging and require support with this process.

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Section: Summary Of Included Papersmentioning

confidence: 99%

Section: Summary Of Included Papersmentioning

confidence: 99%

Section: Summary Of Included Papersmentioning

confidence: 99%

Section: Summary Of Included Papersmentioning

confidence: 99%

Section: Exploring Facilitators and Barriers To Recruitmentmentioning

confidence: 99%

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Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

et al. 2017

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Enhancing Research Capacity for Global Health: Evaluation of a Distance-Based Program for International Study Coordinators

Wilson

Rice

Jones

et al. 2013

Journal of Continuing Education in the Health Professions

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Introduction Due to the increasing number of clinical trials conducted globally, there is a need for quality continuing education for health professionals in clinical research manager (CRM) roles. This paper describes the development, implementation, and evaluation of a distance-based continuing education program for CRMs working outside the United States. Methods A total of 692 applications were received from CRMs in 50 countries. Of these, 166 were admitted to the program in two cohorts. The program, taught online and in English, included four required and one optional course. Course materials were also provided as hard copies and on CDs. A pretest/posttest design was used to evaluate the outcome of the program in terms of changes in knowledge, participants’ capacity-building activities at their research sites; and participant and supervisor perceptions of program impact. Results Participants demonstrated significant improvements in knowledge about clinical research, rated course content and teaching strategies positively, and identified the opportunity for interactions with international peers as a major program strength. Challenges for participants were limited time to complete assignments and erratic internet access. Participants offered capacity building programs to 5061 individuals at their research sites. Supervisors indicated that they would recommend the program and perceived the program improved CRM effectiveness and site research capacity. Findings Results suggest that this type of continuing education program addresses a growing need for education of CRMs working in countries that have previously had limited involvement with global clinical trials.

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Clarifying the role of clinical research nurses working in Sweden, using the Clinical Trial Nursing Questionnaire – Swedish version

et al. 2022

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A registered nurse (RN) can be involved in clinical research by working as a clinical research nurse (CRN). Globally, they are important in clinical research along with various experts from the multidiscipline research team. However, new competence and skills are required for the RNs who become CRNs, whose professional role is positioned between the care of patients and the requirements of the study protocol (Bevans et al., 2011;McCabe et al., 2019).International reports on the working tasks of CRNs are diverse, ranging from conducting simple study-related tasks to being involved in study planning and development of study protocols, data collection, coordination and evaluation of studies, as well as presenting results at conferences and writing articles together with

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The role and potential contribution of clinical research nurses to clinical trials

Abstract: These findings are relevant to the design and conduct of research studies of nursing care and practice and present ways for investigators to optimize the skills and knowledge of nurses working as CRNs.

Cited by 97 publications

References 19 publications

Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

Enhancing Research Capacity for Global Health: Evaluation of a Distance-Based Program for International Study Coordinators

Clarifying the role of clinical research nurses working in Sweden, using the Clinical Trial Nursing Questionnaire – Swedish version

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