Clinical Research Nurses Research Articles

Clinical research nurse utilisation and role in the conduct of decentralised clinical trials: a literature review.

The decentralised clinical trial (DCT) model has been popularised given its remote or virtual design, permitting expanded participant enrolment into community settings. Clinical research nurses (CRNs) are specially trained in the management of clinical trials; however, the utilisation of the research nurse role relating to decentralised trial conduct is not well-established. A literature review was conducted to describe the role of the research nurse in the conduct of DCTs and the current utilisation of this nurse specialty for decentralised trial management. Use of keywords 'DCT' or 'virtual trial' and 'nursing' were used to identify full-text, peer-reviewed literature in the English language and published within the last 10 years that described the clinical research nursing role. Of the 102 pre-screened articles identified across five databases, 11 articles were eligible for full-text analysis. Thematic groupings of common discussion elements included Variance in Decentralised Clinical Trial Model Implementation, CRN Involvement in Decentralised Trial Conduct and Reporting and Shared Challenges of Decentralised Trial Implementation Affecting the CRN Role. Implications of this literature review include expanded trial sponsor awareness of the support requirements to facilitate research nurse utilisation and optimal decentralised trial conduct.

Development of a Japanese Scale that Evaluates the Level of Nursing Support Provided to Patients for Decision-Making in Cancer Clinical Trials.

Clinical nurses need learning programs that are useful in nursing support for patients' decision-making (NSPDM) regarding cancer clinical trials (CCTs). The usefulness of the learning program can be evaluated if the practices of NSPDM before and after participation in the learning program can be compared. We developed a scale to measure the level of self-assessed NSPDM regarding participation in a CCT. Thirty-two items of scale were developed in Japanese based on previous literature. Based on the results of a pilot study, items with similar meanings were removed and the validity of the 26 scale items was statistically examined in terms of construct validity and reliability. The study population was clinical nurses and included clinical research nurses. We received 102 valid responses from clinical nurses. Based on the bias of the boxplot distribution and the ceiling and floor effects for the items analysis of the 26-item draft scale, 17 items remained. Exploratory factor analysis (EFA) revealed that the scale consisted of three subscales and 17 items. Regarding fit indices of the model, the goodness-of-fit index (GFI), adjusted GFI (AGFI), comparative fit index (CFI), and root mean square error of application (RMSEA) were 0.775, 0.704, 0.477, and 0.081, respectively. The Cronbach's alpha coefficient for the overall scale was 0.951, with subscales ranging from 0.820 to 0.942. The validity and reliability of this scale were acceptable. This scale may be helpful to evaluate the usefulness of learning programs, i.e., the practice level of NSPDM.

Clinical research nurses' perceptions of the unique needs of people of color for successful recruitment to cancer clinical trials

BackgroundClinical trials (CTs) test new medical products for safety and effectiveness. Despite federal policy aimed at generating greater inclusivity of people of color (POC) in CTs, disparity in (CT) enrollment persists. Non-Hispanic White patients comprise the majority of CT participants while Black and Hispanic patient participation has declined over the past decade. The scope of Clinical Research Nurses (CRNs) includes recruitment of participants for CTs. The aim of this phenomenological study was to describe adult oncology CRNs' lived experiences of recruiting POC cancer patients to participate in CTs. The first paper for this study identified three major themes regarding how CRNs view their role in caring for POC considering or enrolling onto cancer clinical trials (CCTs): CRNs act as advocates, care coordinators and educators. This paper focuses on two additional major themes regarding how CRNs view the unique needs of POC in clinical research: establishing and maintaining trusting relationships and recruitment infrastructure. MethodsNineteen nurses participated in semi-structured one-to-one interviews and data analysis was based on Colaizzi's method. ResultsCRNs described a history of past research injustices, disparate access to care, inadequate cultural training, a physician-driven recruitment structure and provider-based implicit biases that hinder POC enrollment in CTs. ConclusionDiversity in CCT enrollment requires CRNs to establish trust with POC, advocate for POC when implicit biases are observed and become competent practitioners of culturally sensitive care. Further, meaningful policy change at both federal and organizational levels must occur to ensure equitable access to novel cancer therapies.

Clinical nurses' understanding of the role of the clinical research nurse in the renal unit

Clinical research nurses (CRNs) have been recognised as drivers of success in the conduct of clinical research and clinical trials. However, despite its popularity as a career option, the CRN role is unclear and misunderstood by most clinical nurses. A survey questionnaire was developed and distributed to clinical nurses in the renal unit of a large London hospital to ascertain their understanding of the role of the CRN. Although about 90% of clinical colleagues believed that research was beneficial to patients, a significant proportion (40%) misunderstood the role and 60% were found to have limited or basic understanding. Lack of communication between the CRN and clinical nurses, and research information dissemination emerged as the major contributing factors for this. Developing an approach to address this issue to bridge the gap between these two key nursing specialties is pivotal not only to increase research output but also to augment research awareness and improve working relationships.

Knowledge, attitudes and nursing self-evaluation related to clinical research

Background/Aim: Clinical research nursing is a well-known concept in Europe and other countries. The purpose of this study was to investigate the nurses' knowledge and attitudes towards clinical research and their opinions and self-evaluation about clinical research nursing and factors affecting them. Methods: A cross sectional study was conducted at the University Clinical Centre of the Republic of Srpska (UCCRS). A questionnaire included 50 questions/ statements was created in order to address the aims of the research and afterwards distributed to 120 nurses from 6 departments. Results: Response rate was 91.6 %. Most of the respondents showed a low level of knowledge, but positive attitude related to clinical research. Nurses who participated in clinical research were confident in their competencies according to their self-evaluation. Conclusion: Systematic approach to the additional nurses education could have a significant impact on a success of clinical research.

Abstract P051: The INSPIRE Study (Implementing Next-generation Sequencing for Precision Intervention and Risk Evaluation): scaling return of genomic results

Abstract Background: To enable genomic care for all City of Hope (COH) patients, we implemented an enterprise-wide Precision Medicine program including 7 of our clinical network sites. Consented patients with and without cancer are eligible to opt into germline testing (155 gene cancer predisposition panel and ACMG 59 Actionable Disorders panel) and paired tumor-normal whole exome/RNA transcriptome sequencing. All assays are CAP-CLIA approved. Results are added to the electronic medical record (EMR). We describe the process of implementation through return of results (RoR). Methods: Potentially eligible patients are identified by their provider or through the EMR. Clinical Research Assistants (n=8, main campus) and Advance Practice Providers (APPs) (n=14 Genetic Counselors or n=1 Genetics Nurse Practitioner) and Licensed Vocational Nurses (n=5, clinical network) consent patients in-person and remotely. Clinical Research Nurses (n=5) or APPs order testing through the EMR, with treating providers copied on somatic results and GCs copied on germline results. All results are systematically reviewed by GCs and/or the weekly COH Precision Oncology Tumor Board (POTB). Results: From July 9, 2020 through August 26, 2022 12,105 patients have been offered participation, with 10,376 (85.7%) enrolling (7,892 original consents/ 2,484 reconsents), 735 (6.1%) declining, 984 (8.1%) deferring, and 10 (.1% ) with other consent statuses. 98.9% (10,259/10,376) opted for cancer predisposition germline testing and 98.5% (10,225/10,376) opted for ACMG Actionable Disorders testing 91.5% (9,497/10,376) patients agreed to future contact about additional research studies. 6,512 somatic tests have been reviewed (representing 6,295 patients) and presented through POTB. Somatic genomic results are uploaded to the EMR via PDF and returned by the treating physician. Germline results are returned through the EPIC genomics module. To scale RoR, patients with negative results, variants of unknown significance, and carriers for recessive conditions are sent letters. Patients with a cancer predisposition P/LP variant are disclosed via phone by a GC and referred to COH Cancer Genomics for counseling whereas patients with P/LP non-cancer ACMG variants are referred for outside genetic counseling through the testing laboratory. To improve efficiency, we do not notify patients of non-actionable variant reclassifications. Conclusion: We outline a new care model for the delivery of germline and somatic genetic testing at scale. High consent and opt-in rates for germline testing demonstrate patient interest and feasibility. Future work is planned to assess the impact of testing on clinical care and outcomes. Citation Format: Ilana Solomon, Heather Hampel, Kevin McDonnell, Kathleen Blazer, Alex Capasso, Anuja Chitre, Sandra Dreike, Hunaydah Elfarawi, Lauren Gima, Christine Hong, Gregory Idos, Elisabeth King, Rachelle Manookian, Bita Nehoray, Wai Park, Michael Restrepo, Susan Shehayeb, Elise Sobotka, Duveen Sturgeon, Elyssa Zukin, Stacy W. Gray, Stephen B. Gruber. The INSPIRE Study (Implementing Next-generation Sequencing for Precision Intervention and Risk Evaluation): scaling return of genomic results. [abstract]. In: Proceedings of the AACR Special Conference: Precision Prevention, Early Detection, and Interception of Cancer; 2022 Nov 17-19; Austin, TX. Philadelphia (PA): AACR; Can Prev Res 2023;16(1 Suppl): Abstract nr P051.

How clinical research nursing is shaping the future of urology trials

Nursing research has been developing, particularly over the past 15 years. The role of the clinical research nurse (CRN) is vital because of nurses' high level of patient contact. They are therefore involved in the identification of suitable study participants, initial contacts, enrolment, monitoring and follow-up. The COVID-19 pandemic has emphasised the importance of research to government, the NHS and patients. In this article, the author describes three research studies in which she has taken part and emphasises the importance of research and the role of CRNs in bringing together nursing, medicine and science through the CRN's specialist knowledge and how this particular career choice in nursing is now gaining greater attention and momentum.

Development and Effects of Pre-clinical Research Nurse Programs of Nursing Students

Objectives: Clinical research nurses play an important role in clinical trials. The purpose of this study was to identify the effect of pre-clinical research nurse program on biomedical ethics awareness, critical thinking disposition and teamwork in nursing students. Methods: This study was a non-equivalent control group pretest-posttest quasi-experimental design: the participants included 55 nursing students (28 in the experimental and 27 in the control group). Biomedical ethics awareness, critical thinking disposition and teamwork between the experimental and control groups were measured before and after the program participation. Data were collected from November 1 to 19, 2021 by taking a self reported survey and analyzed by using Chi-square test, Fisher’s exact test, Independent t-test, and Paired t-test with SPSS WIN 25.0 program. Results: The experimental group showed higher biomedical ethics awareness (t=2.15, <i>p</i>=0.036) relative to those of the conrol group after the program participation. However, there were no statistical differences in critical thinking disposition (t=1.29, <i>p</i>=0.204) and teamwork (t=1.97, <i>p</i>=0.054) between the twp groups. Conclusions: According to these results, pre-clinacal research nurse program developed in this study could be used to increase biomedical ethics awareness of nursing students. In addition, there is a need to develop modified programs with various teaching methods to increase the level of critical thinking disposition and teamwork as well as biomedical ethics awareness in nursing students who may become clinical research nurses in the future.

A CiteSpace-Based Analysis of the Development Trends Affecting Clinical Research Nurses in China: A Systematic Review.

ObjectiveTo examine the developmental characteristics and trends affecting clinical research nurses (CRNs) in China and provide a reference for the training and employment of nursing talents in this specialty.MethodsLiterature pertaining to CRNs published from the year in which the database was constructed to 2020 was searched. The databases used were the China National Knowledge Infrastructure, Wanfang, Chinese Biomedical Literature and Weipu, while CiteSpace software was used to conduct a bibliometric analysis of literature quantity, annual distribution, literature journals and regional distribution, literature authors, subject funding status and literature type and keywords. The characteristics and trends affecting CRNs in China were then evaluated using a descriptive analysis.ResultsA total of 3735 pieces of literature were retrieved, and after deduplication and screening, 199 pieces of literature were retained for this study. Overall, the number of publications increased year-on-year. Of these publications, 17 papers (8.5% of the retained papers) were published in the Chinese Journal of Modern Nursing and 9138 papers (69.3%) were published in the top 10 regions according to the location of the first author (of these, 31 [15.6%] were published in Beijing and 42 [21.1%] were funded by scientific research funds). The research fell mainly in the experience summary category, with 107 articles (53.8%) taking this approach. The top five research hotspots were clinical research, good clinical practice (GCP), research nurses, management and clinical trials. The practice and exploration of CRNs were regionalised, accounting for varying degrees of development. CRNs were found to be at the forefront of developments in oncology specialties.ConclusionIn China, CRNs are currently in a period of rapid development. Research into CRNs mainly involves single-centre studies and lacks financial support. In the future, it will be necessary to increase capital investment, strengthen cross-regional cooperation between authors and institutions to narrow the regional development gap, and promote strict and standardised CRN training models and qualification certification to improve the quality of clinical research nursing.

OA27 Growth of the UK and Ireland paediatric rheumatology nurses’ group

OA27 Growth of the UK and Ireland paediatric rheumatology nurses’ group

Trouble for trials - The worrying state of the research nurse workforce

Clinical research nurses (CRNs) are a specialty of Registered Nurses that are highly trained to support the breadth of clinical trial operations and manage participant care in community settings new to research. CRNs are uniquely equipped with a scope of practice that permits product administration, participant assessments, and data management. As clinical trials and their management expand beyond traditional, site-based operations models to decentralized or remote models, the need becomes great to ensure adequate staffing of experienced research professionals, such as CRNs. However, the 2020 National Nursing Workforce Survey reported consecutive contractions in the number of CRNs practicing in the U.S in both 2017 and 2020 surveys when compared to previous reports in 2013 and 2015. The Society of Clinical Research Associates 2020 Salary Survey further described much of the current CRN workforce as nearing or at retirement age, raising concern for additional reductions. This workforce contraction tangents one of the highest volumes of clinical trial starts in modern history, prompting concern for adequate staffing of CRNs to facilitate continued examination of novel therapies and devices. Complex investigative products and evolving safety profiles coupled with an increased focus on community participant enrollment requires CRN involvement in heightened safety monitoring and interdisciplinary communication among clinical providers and research collaborators. This paper examines the contributory factors of the CRN workforce contraction and response efforts at professional and organizational system levels.

Transitioning to the clinical research nurse role - A qualitative descriptive study.

Studies have reported on the important role of the clinical research nurse in clinical studies. Yet, there is no international consensus about the role's competencies and tasks. Furthermore, the literature offers a little description of the career pathway from a ward-based registered nurse to a clinical research nurse. More knowledge about this specific role could benefit the nursing profession as well as increase the quality of clinical research. The aim of the study was to explore Swedish registered nurses' experiences transitioning into the clinical research nurse role. The study had a qualitative design. Data were collected via semi-structured interviews. Inductive qualitative content analysis was employed. Ten participants (i.e., clinical research nurses) were interviewed in the spring of 2017. A semi-structured interview guide was used to address the transition into the clinical research nurse role, experience working in a new role, experience of ethical dilemmas and experience of organizational and professional issues related to the role. The interviews were analysed inductively using qualitative content analysis. The registered nurses described experiencing reality shock when they became clinical research nurses; that is, it was a challenging and transforming experience. The main theme, a challenging transition, was developed from the four subthemes highlighting that it defied their previous nursing role. They experienced an unclear professional identity, extended professional mandate, increased professional status and growing ethical consciousness in their new role. The results highlight that registered nurses who became clinical research nurses had needs that were both distinct from and overlapped with those of their former professional role as registered nurses. To avoid reality shocks, the development of clear competence pathways for nurses to become clinical research nurses, including introduction, mentorship and continued support, is necessary. Making their professional title more homogeneous, nationally and internationally, would facilitate role identification and comparisons in research.

The Role and Function of Clinical Research Nurses in Anti-tumor Drug Clinical Trials for Lung Cancer Patients

抗肿瘤药物临床试验既是新药研发的必经之路，也是最前沿的恶性肿瘤治疗方法，给患者带来了更多生存机会。肺癌药物临床研究数目大，研究药物品种繁多，研究进展快，临床转化效率高，这些试验的成功开展离不开研究团队的共同努力，其中研究护士也发挥了不容小觑的作用。结合临床研究护士的工作内容，本文详细介绍了开展肺癌药物临床试验过程中研究护士的岗位管理、角色职能、核心能力及职业发展前景，以期为更多医疗机构开展相关工作提供参考，促进临床研究护士向规范化专业化深入发展。

Moral distress in clinical research nurses.

Background: Clinical research nurses experience unique challenges in the context of their role that can lead to conflict and moral distress. Although examined in many areas, moral distress has not been studied in clinical research nurses.Research aim: The aim of this study was to examine moral distress in clinical research nurses and the relationship between moral distress scores and demographic characteristics of clinical research nurses.Research design: This was a descriptive quantitative study to measure moral distress in clinical research nurses using the Measure of Moral Distress - Healthcare Professionals (MMD-HP) administered electronically. Demographic data were also collected.Participants and research context: Registered nurses working in the clinical research nurse role (N = 322) were recruited through use of social media, emails, digital flyers, and snowball recruitment. Data was analyzed using SPSS. Pearson's correlation, independent t-test, and one-way ANOVA were performed to explore differences among the demographic variables.Ethical considerations: This study was approved by the Institutional Review Board at Texas Woman's University. A consent statement was included, and completion of the questionnaire was construed as consent.Findings/results: Analysis revealed a mean overall moral distress score of 79.58 (SD = 64.27) and median of 67, with a range of 0-354. Moral distress scores were negatively correlated with clinical research nurse age (r = 0-.156, p < 0.05). Reliability of the MMD-HP was demonstrated with a Cronbach's alpha of 0.93.Conclusions: The findings demonstrate that clinical research nurses do experience moral distress and revealed a wide range of scores. Further research is necessary to determine potential patient impact due to moral distress and to develop processes to minimize moral distress in the clinical research setting. This study was conducted during the COVID-19 pandemic, and the digital recruitment methods proved effective in recruiting a wide range of clinical research nurses, both nationally and internationally.

Ethics are central to nursing care

In this month's BANCC column, Helen Eftekhari takes a look at the ethics that guide cardiac nurses in clinical practice and research.

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

AimTo explore the role of CRNs in Sweden and differences in competences and tasks, using the Clinical Trial Nursing Questionnaire – Swedish version (CTNQ‐SWE).DesignA cross‐sectional survey.MethodsParticipants were identified through strategic sampling. Data were analysed by descriptive and comparative statistics.ResultsThe respondents were experienced nurses who felt proficient in their role, they felt more acceptance by the principal investigators than by nursing colleagues. A majority of CRNs are involved in all procedures specified in the CTNQ‐SWE. The most often performed tasks, also rated as the most important by the CRNs, concerned informed consent and management of investigational products. The education was often informal: with a lack of job descriptions and professional development plans. Need of formal specialist education was expressed.ConclusionsKnowledge about the role description can be used by clinical research enterprise internationally and healthcare organizations aiming to support CRNs in their role.

Development and Implementation of an Oncology Clinical Research Nursing Residency Program for Newly Licensed Nurses.

A paucity of nurses trained in clinical research prompted the development and implementation of a newly licensed nurse residency program in oncology research. The components of the program, funding, curriculum development, preceptor model, and partnerships, are described. Formal evaluation to quantify success in creating a pipeline for the future, increasing retention, and reducing costs is underway and will be reported in a future publication.

The 2022 ANCC Institute for Credentialing Research and Quality Management Priorities: A Path Forward in Nurse-Led Research.

It is imperative that we listen to our nation's nurses, who have a unique vantage point from their clinical environments. Clinical research nurses have greatly contributed to studying the delivery of care over the years; however, since 2020, COVID-19 has brought unprecedented changes within the nursing profession. Each wave of the pandemic has created a worrisome landscape where nurse researchers face multiple challenges in implementing and funding practice-based nursing-led research projects. To raise nurses' voices and promote nurse-led research, the American Nurses Credentialing Center (ANCC) Research Council 2022 Research Priorities include the dissemination of a research agenda for practice-based research, promoting interprofessional research, and encouraging equitable and inclusive participation on research teams.

Duality of practice in clinical research nursing.

International evidence suggests that Clinical Research Nurses (CRN) can have a dual role incorporating both clinical care and research responsibilities. This duality of role often assists in meeting the clinical care and research needs of the participants and can contribute to the credibility of the CRN role. Conversely, it can also lead to feelings of confusion and role conflict as CRN's time is divided. To identify and explore experiences of clinical and research roles among CRNs. This emerged as a theme in a wider research project exploring CRNs' experiences of working with clinical nurses. Following an Interpretative Phenomenological Analysis approach, 10 CRNs participated in face-to-face semi-structured interviews. Transcribed data were analysed and a number of themes emerged. Duality of role was one of these. Findings indicated that if CRNs fulfil a dual role, this can assist in care provision, research delivery and in building positive relationships with clinical nurses. However, there were also instances when a dual role led to clinical nurses questioning the value of research and to issues with competing demands of clinical care and research. These experiences had an important impact on some of the CRNs and led to reflection on the value of their role. This study identifies new understandings of a dual role of the CRN. The findings will inform the preparation and practice of this group of nurses, whilst also leading to a deeper understanding of the CRN's role in care and research delivery. It will also contribute to a wider appreciation of organisational factors and social interactions that impact on health care research.

Nurses in clinical trials: perceptions of impact on the research enterprise.

Clinical Research Nurses practice across a wide spectrum of roles and settings within the global research enterprise. Clinical Research Nurses working with clinical trials face a dual fidelity in their role, balancing integrity of the protocol and quality care for participants. The purpose of this study was to describe Clinical Research Nurses' experiences in clinical trials, educational preparation, and career pathways, to gain a deeper understanding of clinical research nursing contributions to the clinical research enterprise. An internet-based survey was conducted to collect demographic data and free text responses to four open-ended queries related to the experience of nurses working in clinical trials research, educational preparation, and role pathways. Qualitative content analysis was used to analyze free text responses. The study was guided by the Clinical Research Nursing Domain of Practice and Duffy's Quality Caring Model of relationship centered professional encounters. Forty clinical research nurses responded to the open-ended questions with themes related to dual fidelity to study participants and protocols, relationships and nursing care, interdisciplinary team membership and contributing to science, emerging from the data. Gaps in educational preparation and professional pathways were identified. This study provides insights to unique clinical research nurse practice contributions in the clinical trial research enterprise within a context of Duffy's Quality Caring Model.