The Essential Role of the clinical Research Nurse (CRN)

Poston, Rebecca; Buescher, Christine R

doi:10.7257/1053-816x.2010.30.1.55

Cited by 58 publications

(38 citation statements)

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“…Yet, given limited PI time to participate in lengthy informed consent processes, clinical research coordinators (CRCs) often serve on the front lines of site level recruitment, randomization, retention, data collection, and reporting adverse events. [20] Although the ability of CRCs to influence the patient composition of clinical trials and the potential for selection bias has long been recognized,[20–22] most research on barriers to clinical trial recruitment has focused on organizational, medical provider and patient-level barriers. [23, 24] Despite the considerable influence of CRCs on the composition of clinical trials, relatively little research has been conducted to understand factors that may influence their engagement with patients.…”

Section: Introductionmentioning

confidence: 99%

Barriers and Strategies for Recruitment of Racial and Ethnic Minorities: Perspectives from Neurological Clinical Research Coordinators

Haley

Southwick

Parikh

et al. 2017

J. Racial and Ethnic Health Disparities

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Introduction Randomized Controlled Trials (RCTs) are the gold standard within evidence-based research. Low participant accrual rates, especially of underrepresented groups (e.g., racial-ethnic minorities) may jeopardize clinical studies’ viability and strength of findings. Research has begun to unweave clinical trial mechanics including the roles of clinical research coordinators, to improve trial participation rates. Methods Two semi-structured focus groups were conducted with a purposive sample of 29 clinical research coordinators (CRCs) at consecutive international stroke conferences in 2013 and 2014 to gain in-depth understanding of coordinator-level barriers to racial-ethnic minority recruitment and retention into neurological trials. Coded transcripts were used to create themes to define concepts, identify associations, summarize findings, and posit explanations. Results Barriers related to translation, literacy, family composition and severity of medical diagnosis were identified. Potential strategies included a focus on developing personal relationships with patients, community and patient education, centralized clinical trial administrative systems, and competency focused training and education for CRCs. Conclusion Patient level barriers to clinical trial recruitment are well documented. Less is known about barriers facing CRCs. Further identification of how and when barriers manifest, and the effectiveness of strategies to improve CRCs recruitment efforts is warranted.

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Section: Introductionmentioning

confidence: 99%

Barriers and Strategies for Recruitment of Racial and Ethnic Minorities: Perspectives from Neurological Clinical Research Coordinators

Haley

Southwick

Parikh

et al. 2017

J. Racial and Ethnic Health Disparities

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“…9, 20, 21 Xanthos et al have noted, “A holistic, caring approach fostered by nurses not only results in successful management of a complex protocol but also humanizes the research process for participants.” 22 Likewise, Davis et al found that coordinators perceived both caring and detachment as necessary in the research process. 6 Hence, it is important to determine how coordinators, particularly nurse coordinators, deal with the potential conflicts in their jobs.…”

Section: Introductionmentioning

confidence: 99%

Altruism in clinical research: Coordinators’ orientation to their professional roles

Fisher¹,

Kalbaugh²

2012

Nursing Outlook

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Background Research coordinators have significant responsibilities in clinical trials that often require them to find unique ways to manage their jobs, thus re-shaping their professional identities. Purpose The purpose of this study is to identify how research coordinators manage role and ethical conflicts within clinical research trials. Method A qualitative study combining observation and 63 semi-structured interviews at 25 research organizations was used. Discussion Altruism is a recurring theme in how research coordinators define and view their work. Conclusion Altruism is adopted by research coordinators: 1) to teach patient-subjects the appropriate reasons to participate in clinical research, 2) to minimize the conflict between research and care, and 3) to contest the undervaluation of coordinating. Altruism is a strategy employed to handle the various conflicts they experience in a difficult job, and it has become part of the professional identity of clinical research coordinators.

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“…Adverse event management, including proper and timely reporting to sponsors, is an important responsibility of the CRC [5]. A key function of managing serious adverse events is the collection of data on whether or not the subject sought consultation from other medical institutions.…”

Section: Discussionmentioning

confidence: 99%

Serious adverse events and compensation in registration trials: a review of data from a Japanese university hospital

et al. 2014

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BackgroundClinical trials leading to regulatory approval, or registration trials, play a central role in the development of drugs and medical devices. The contribution of support staff, such as the clinical research coordinator (CRC) and administrative officers, in registration trials is now widely recognized. Attending to serious adverse events is an important duty of the CRC and investigators alike, and managing these complications and compensation constitutes a key responsibility. We retrospectively examined the frequency of serious adverse events and compensation events reported from 2007 through 2011 at Tokushima University Hospital, an academic hospital in rural Japan. We present herein the results of our analysis.ResultsOver the five-year period, 284 subjects participating in 106 registration trials experienced a total of 43 serious adverse events, and eight compensation events were documented. Among the serious adverse events, 35 (81.4%) were considered not related to the investigational drug, and 17 (39.5%) resulted in withdrawal of the study drug. Patients with malignant diseases experienced serious adverse events significantly more frequently compared to those with non-malignant diseases (28.3% versus 8.2%, respectively; P < 0.01).ConclusionsThe CRC should be vigilant for serious adverse events in oncology clinical trials due to the generally higher frequency of these complications in subjects with malignancy. However, on an individual basis, the CRC may be seldom involved in the process for compensating serious adverse events. Therefore, the CRC’s ability to share such experiences may serve as an opportunity for educating clinical trial support staff at the study site as well as those at other sites. However, further study is warranted to determine the role of the clinical trial support staff in optimizing methods for managing adverse events requiring compensation in registration trials.

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The Essential Role of the clinical Research Nurse (CRN)

Cited by 58 publications

References 0 publications

Barriers and Strategies for Recruitment of Racial and Ethnic Minorities: Perspectives from Neurological Clinical Research Coordinators

Barriers and Strategies for Recruitment of Racial and Ethnic Minorities: Perspectives from Neurological Clinical Research Coordinators

Altruism in clinical research: Coordinators’ orientation to their professional roles

Serious adverse events and compensation in registration trials: a review of data from a Japanese university hospital

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