Clinical Trial Nurses Research Articles

Optimizing clinical research in a regional cancer center network: A survey-based approach.

e13560 Background: Conducting clinical research (CR) within regional care networks (RCNs) of comprehensive cancer centers presents unique challenges. This study aimed to identify and address such barriers at Memorial Sloan Kettering Cancer Center's (MSKCC) RCN, encompassing six sites across New York and New Jersey. Methods: A survey was conducted among medical oncologists at the RCN sites (February 2022-February 2023) to assess their perspectives on research-related challenges. The 23-question survey included multiple-choice, open-ended, and ranking questions regarding protocol availability, consenting processes, staffing support, and more. Results: 92/108 (85%) medical oncologists completed the survey, revealing three key challenges: 1. Limited protocol availability: Only 47% of the time was there a suitable trial available in the RCN for patients interested in clinical trials. Notably, 50% of attendings referred over 5 patients out of the RCN to MSKCC Main Campus for trial enrollment. Identified barriers to opening desired protocols (n=23 in total) included closed to accrual, pending amendments, and sponsor approval issues. 2. Inadequate investigator representation: 278 protocols lacked RCN physicians listed as consenting providers hindering potential patient participation. 3. Insufficient research staff including clinical trial nurses and administrative staff. Only 33% were satisfied with the research support, and 67% of physicians identified lack of clinical research support staff as the biggest barrier to accrual. 58% reported delays of more than one week in screening eligible patients due to insufficient support. Following these observations, interventions were implemented. Thirteen of the 23 studies were opened to accrual, all RCN physicians were added to the 278 protocols, and an analysis of staffing needs increased clinical trial nursing and administrative staff. Therapeutic and non-therapeutic accruals in the Department of Medicine rose by 10.5%, and total research visits increased by 21.4% compared to the previous year. Conclusions: This survey-based approach identified and addressed key barriers to CR within MSKCC's RCN, and in turn, increased research activity was noted. These findings offer a potential roadmap for optimizing research in similar networks by enhancing protocol accessibility, addressing staffing needs, and fostering collaboration. Further investigations are ongoing to address challenges in other clinical departments.

간호대학생을 위한 팀프로젝트기반 임상시험연구 교육의 효과

Objectives Project-based learning engages students in practical activities related to course contents and has been demonstrated to improve academic performance. Nurses play a particularly important role in promoting clinical trial research as a new professional workforce. An entry-leveled educational course was developed to learn the future professional workforce roles in clinical trial research for nursing students. This study evaluated the effectiveness of a clinical trial research course on the importance and performance of the clinical research coordinators' role, students' recognized achievement, and cooperative self-efficacy.
 Methods Five professional clinical coordinators and two nursing professors developed the four projects on the clinical research processes and roles based on Good Clinical Practice guidelines. Thirteen junior students divided into 4 small groups completed a new project-based clinical research course composed of 8 sessions of clinical field work, discussion, reflection, portfolio, and presentation from September to October 2022. Students responded questionnaires on the importance-performance clinical trial nurses' roles, recognized achievement, and cooperative self-efficacy, and reported the reflective journal on the class. The students' class evaluation data was retrieved and analyzed using importance-performance analysis (IPA) and Wilcoxon signed rank test.
 Results Compared to baseline scores, protocol assessment (z=-2.59, p=.010), protocol planning (z=-1.96, p=.050), and subject recruitment (z=-2.16, p=.031) increased among the 8-section of clinical trial coordinator's roles. Additionally professional role recognition increased after the class (z=-2.25, p=.025). IPA analysis exhibited that nursing students recognized the 8-section clinical trial nurses' roles as more important and more performing. The mean score of nursing students' recognized achievement was high (4.96 points out of 5 points), and cooperative self-efficacy was high (4.37 points out of 5 points) after completing a clinical trial research course.
 Conclusions An entry-leveled educational course on the clinical trial research using project-based learning may expand the possibility of a new professional career for nursing students.

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。

Perceived end-of-life educational needs by clinical trials nurses at a comprehensive cancer center

ObjectiveDetermine palliative care end-of-life (EOL) educational needs among clinical trials nurses (CTNs) at an urban comprehensive cancer center. MethodsThe End-Of-Life Professional Caregiver Survey (EPCS) was used to determine the EOL educational needs of CTNs and collect demographics on years of experience, education, past EOL-specific training, and possession of their own advanced directive. The “Surprise Question” was also asked to explore the percent of patients on clinical trials who may be nearing EOL. ResultsTwenty-nine CTNs completed the survey. Mean years of experience as an RN and CTN was 10.45 and 2.5, respectively. 79% and 17% held a bachelors or master's degree, respectively. Twenty-seven percent reported previous End-of-Life Nursing Education Consortium (ELNEC) or similar training and 20% stated they had their own advanced directive. Mean total score for the EPCS was 94.83, with subscale means of 42.41 for the Patient and Family Centered Communication (PFCC), 26.9 for Cultural and Ethical Values (CEV), and 25.52 for the Effective Care Delivery (ECD). Highest scoring items included confidence in communicating with colleagues about EOL care, being present with dying patients, and recognizing patients who are appropriate for hospice referral. Lowest scoring items included participating in code status discussions, resolving ethical issues and family conflicts at EOL, and addressing requests for assisted suicide. Responses to the Surprise Question indicated that 27.5% of the CTNs would not be surprised if half or more of their patients died within the next 12 months. ConclusionsMany patients with cancer on clinical trials may be nearing EOL. CTNs perceive the need for education to increase confidence in handling difficult communication.

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.

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

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

The Role of Study Nurses in Clinical Trials of IBD Drugs

Objective: To explore the establishment and roles of study nurses in IBD drug clinical trials. Methods: The management experience of this department’s study nurses in IBD drug clinical trials was retrospectively analyzed. Results: The study nurses played very important roles at all links during the preliminary preparation of IBD drug clinical trials, the whole-process management after project initiation, and the later work of project conclusion. Conclusions: As direct participants in drug clinical trials, study nurses play a very important role in ensuring standardization of the trial process, safeguarding patient’s rights and safety, and assisting investigators in carrying out study works smoothly.

Oncology clinical trials nursing: A scoping review.

In the 21st century, cancer is a disease that captures much of our attention for its complexity, and its physical, emotional, and financial impacts on one's life. Research attention and investment in cancer management has made it the most studied disease in clinical trials globally. Clinical trials nurses are part of the oncology research team and a fundamental factor in trial success. Their direct relationship with research subjects is the key connection in the operation of clinical trials at the front line. The influx and complexity of oncology clinical trials has transformed both oncology nursing practice in general and led to the development of the unique subspecialty of the oncology clinical trials nurse. This scoping review investigated the role and future practice of the clinical trials nurse.

The role of clinical trial nurses: Transitioning from clinicians to clinical research coordinators.

This study aimed to explore the role of clinical research coordinators (CRCs) and identify the importance and performance of the role as well as the factors that affect the professional recognition of their role. A total of 102 CRCs from 10 hospitals were recruited for a survey. The Clinical Trial Nursing Questionnaire scale developed by Ehrenberger and Lillington was used to collect data for the importance-performance analysis. The importance and performance data were plotted on a two-dimensional grid, and multiple stepwise linear regression analysis was used to determine the influencing factors on the CRC role. The influencing factors on the importance of the CRC role were frequency of protocol assessment, implementation and evaluation and professional nursing role performance. The influencing factors on performance were formal education and training in clinical research, institutional career ladder system for professional development and identification as a principal investigator in research studies. The influencing factor on the professional nursing role perception was the lower component of the 'performance of professional nursing role'. Formal educational preparation, identification as a principal investigator in research studies and clear career progression are supportive factors to the professional recognition of CRC as a specialized nursing role.

Oncology Nurse Coordinators in Clinical Trials – Shaking up the Melanoma Team

In recent years, melanoma research has undergone a renaissance. The disease that was once viewed, at least in a metastatic setting, as intractable and untreatable is now revealing its molecular “weaknesses.” The year 2011 was a landmark year for melanoma therapy, with the introduction of two new agents – the anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody ipilimumab and the BRAF (V-raf murine sarcoma viral oncogene homolog B1) inhibitor vemurafenib. These two agents were shown to confer a survival benefit, which was followed by the approval by the Food and Drug Administration (FDA). In 2014, other immune checkpoint inhibitors, such as pembrolizumab and nivolumab, were approved for the treatment of metastatic melanoma. By 2019, the FDA had also approved pembrolizumab as adjuvant therapy. Target therapy and immunotherapy are now the standard of care for melanoma patients. Clinical trials are currently ongoing for new neoadjuvant therapies. Rapidly evolving knowledge will perhaps downgrade melanoma to the level of a chronic, manageable disease from the intractable “black cancer,” it was in the past and a disease that struck fear into the hearts of those who were diagnosed. Changes in immunotherapy treatments were followed by a large volume of clinical trials. This situation has resulted in the need for changes in the roles of existing melanoma multidisciplinary team members, including the clinical trials nurse (CTN). The role of the CTN is not suitable for these new conditions. A new role and tasks need to be established, evolving the CTN into an oncology nurse coordinator (ONC). In this article, we have described the role and responsibilities of an ONC and the changes that have taken place within the multidisciplinary melanoma team.

Ethical Challenges Encountered by Clinical Trials Nurses: A Grounded Theory Study.

To investigate the ethical challenges experienced by oncology clinical trials nurses (OCTNs) during the management of CTs and to examine how they resolve those conflicts. 12 licensed RNs who had been practicing as full- or part-time OCTNs for a minimum of two years at various academic medical centers in the United States. Classical grounded theory (CGT), an inductive methodology used to explore a social process in which little is known and to develop a theory grounded in the data, was used, in addition to CGT data analysis strategies. CGT data analysis revealed the OCTNs' main concern (implementing an undefined job) and the way in which the OCTNs resolve this concern through the process of figuring it out. Figuring it out consists of learning as they go, utilizing their assets, standing their ground, and managing hope. Although some nursing research provides examples of ethical challenges OCTNs might encounter in practice, there is little information regarding how nurses manage those encounters. A theoretical understanding of the OCTNs' experiences managing ethical challenges fills a gap in the nursing literature and provides a framework for how OCTNs manage and respond to challenges in professional practice.

Gatekeeping in cancer clinical trials in Canada: The ethics of recruiting the "ideal" patient.

BackgroundPerspectives of clinical trial (CT) personnel on accrual to oncology CTs are relatively absent from the literature. This study explores CT personnel's experience recruiting patients to oncology CTs.MethodsA qualitative study design was utilized. In‐depth, individual interviews with 12 oncology CT personnel were conducted, including six CT nurses and six physician‐investigators. Interviews were digitally recorded and transcribed verbatim. Data were subjected to thematic and ethical analysis to identify key concepts and themes.ResultsCT personnel reported considering two ethical commitments in CT recruitment: maintaining trial integrity and ensuring patient autonomy through obtaining informed consent. The process of gatekeeping emerged as a way to navigate these ethical commitments during CT accrual. Gatekeeping was influenced by: (a) perceptions of patients’ personal suitability for a trial, and (b) healthcare resources and infrastructure. CT personnel's discernment of personal suitability was influenced by patients’ cognitive and mental health status, language and cultural background, geographic location, family support, and disease status. Three structural factors impacted gatekeeping: complexity of CTs, consent process, and time limitations in the healthcare system. CT personnel experienced most factors as constraints to accrual and gaining patients’ informed consent.ConclusionCT personnel discussed navigating ethical challenges in CT recruitment by offering enrollment to specific patient populations, exacerbating other ethical tensions. Systems‐level strategies are needed to address barriers to ethical CT recruitment. Future research should investigate the role of policies and/or tools (eg, decision aids) to support patients and CT personnel's discussions about CT participation, promote more ethical recruitment, and potentially increase accrual.

Annotation of Somatic Genomic Variants in Hematologic Diseases Using OncoKB, a Precision Oncology Knowledgebase

Background: Over 300 somatic molecular variants in hematologic diseases are either specified as diagnostic criteria in the World Health Organization (WHO) Classification of Tumors of Hematopoietic and Lymphoid Tissues, recognized as potentially actionable biomarkers in the National Comprehensive Cancer Network (NCCN) compendia, or supported by published well-powered clinical studies. Moreover, new molecular alterations with potential clinical implications in hematologic disease are continuously emerging in the scientific literature. These have critical use for a wide spectrum of clinicians, including hematopathologists who diagnose patient-specific hematologic malignancies, heme-oncologists who direct patient care, and clinical trial nurses who assist patients in finding appropriate clinical trials. Importantly, the utility of this information critically depends on the clinician's ability to interpret the significance of variants in a point-of-care setting. Therefore, there is an urgent and unmet need for a clinical decision support system that 1) distills the clinical implications associated with molecular alterations into a standardized and easily interpretable format and 2) democratizes access of this information to all members of the heme-oncology community. Methods: OncoKB is an established expert-guided precision oncology knowledge base that annotates the oncogenic effect and therapeutic implications of somatic molecular alterations (Chakravarty, D. et al., JCOPO, 2017). Previously, OncoKB was focused primarily on solid tumor mutation annotation. Recently, we expanded OncoKB to include alterations in hematologic malignancies. The heme-specific annotation efforts were guided by heme-oncology and hematopathology physician scientists at Memorial Sloan Kettering (MSK). Supplementing the previously published therapeutic levels of evidence (Fig. 1a), we further added level of evidence systems for diagnostic and prognostic implications (Fig. 1b, c). These three sets of evidence levels are consistent with the criteria set forth by the joint consensus of the ASCO/CAP/AMP guidelines (Li, MM. et al., J Mol Diagn, 2017). We assigned the newly curated heme-specific molecular alterations with diagnostic, prognostic or therapeutic levels of evidence, when applicable. Finally, we annotated and analyzed 1569 hematologic tumor samples from the AACR Project GENIE (release 6.1) with these levels of evidence. Results: In addition to alterations with both solid and heme clinical implications already curated in OncoKB, we annotated 288 unique heme-specific mutations, fusions, and copy number alterations in 156 newly curated cancer-associated genes. Based on MSK-expert consensus, the WHO and NCCN guidelines, and the scientific literature, we identified a total of 192 alterations with unique diagnostic levels of evidence, 65 alterations with unique prognostic levels of evidence and 55 alterations with unique therapeutic levels of evidence across 13 major hematologic tumor types (Fig. 2). To test the utility of OncoKB, we annotated all genomic events in 1569 heme cancer samples in 89 hematologic malignancies in the AACR GENIE cohort (V6.1) (Fig. 3a). Thirty-eight percent of samples harbored at least one potentially actionable alteration, and 8% were predictive of clinical benefit from an FDA-approved drug (Fig. 3b). Conclusions: OncoKB heme data is publicly available both through the web resource http://oncokb.org and through incorporation into the cBioPortal for Cancer Genomics. Heme-specific molecular alterations are used to make an accurate diagnosis, inform prognosis, optimize the use of stem cell transplant, and to link patients with the optimal mechanism-based therapies in the clinical trial setting and in routine clinical practice. This is the first study to annotate and analyze actionability of heme samples. In this proof-of-principle study, we demonstrate the ability to annotate clinical samples with their diagnostic, prognostic and therapeutic implications in a point-of-care setting. Disclosures Roshal: Celgene: Other: Provision of Services; Auron Therapeutics: Equity Ownership, Other: Provision of services; Physicians' Education Resource: Other: Provision of services. Ho:Invivoscribe, Inc.: Honoraria. Knorr:Fate Therapeutics: Patents & Royalties. LaFave:Epizyme: Patents & Royalties. Arcila:Invivoscribe, Inc.: Consultancy, Honoraria. Berger:Roche: Consultancy. Solit:Pfizer: Consultancy; Lilly Oncology: Honoraria; Vivideon Therapeutics: Consultancy; Loxo Oncology: Consultancy, Equity Ownership; Illumina: Consultancy. Dogan:Celgene: Consultancy; Seattle Genetics: Consultancy; Corvus Pharmaceuticals: Consultancy; Roche: Consultancy, Research Funding; Novartis: Consultancy; Takeda: Consultancy. Levine:C4 Therapeutics: Membership on an entity's Board of Directors or advisory committees; Qiagen: Membership on an entity's Board of Directors or advisory committees; Isoplexis: Membership on an entity's Board of Directors or advisory committees; Loxo: Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Research Funding; Novartis: Consultancy; Gilead: Consultancy; Imago Biosciences: Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria; Lilly: Honoraria; Prelude Therapeutics: Research Funding; Roche: Consultancy, Research Funding.

The conundrum of clinical trials and standard of care in sub-Saharan Africa - the research nurse perspective.

Nurses form a very important part of the health workforce in sub-Saharan Africa. Research nurses are critical to the implementation of clinical trials. The duties and responsibilities of a research nurse are complex and continue to evolve as new practices and guidelines are formulated. In this paper, we have highlighted the major contributions of research nurses in HIV clinical trials in sub-Saharan Africa from the unique perspective of Ugandan nurses. The requirements and challenges of two multi-site, randomised cryptococcal meningitis clinical trials in Uganda were assessed from the perspective of research nurses conducting complex research in resource-limited settings. Over the course of 8 years, approximately 1739 participants were screened and 934 people were enrolled into the two trials. The nurses found that patient education and engagement were among the most important predictors of success in minimising loss to follow-up. Research nurses played a key role in communicating clinical research goals to patients, obtaining informed consent, minimising loss to follow-up, and ensuring that research practices are translated and implemented into standard of care. However, there remains a need to integrate the same level of care provided in clinical research studies to non-study patients.

Development of the CCRU kit squad: Centralization of biospecimen “kit” management.

295 Background: Personalized medicine has resulted in a rapid increase in biospecimens collection. Each biospecimen collected requires supplies that are provided in the form of “kits”. The number of kit types per protocol ranges anywhere from 2-60, with an average of 30 different kit types per trial. Historically, each trials nurse has managed their own kits resulting in large amounts of nursing time being spent on kit management. Kits took up a large amount of space in clinical areas, including expired kits, and they were being managed in no standardized fashion. Due to rapidly increasing biospecimen volumes, existing methods of kit management were no longer feasible and the CCRU Kit Squad was developed. Methods: Over the course of 12-mos, an extensive assessment of current kit management practices were reviewed with all disease site groups, including workflows and quantities utilized. An e-commerce software platform was selected, and semi-customized to centralize online ordering and receiving of kits, and the creation of a central location was setup for kit storage and daily operations. On-boarding of each group included retrieving existing kits from each nurse, uploading kits to the software, training each nurse to use the software, setting up accounts with each respective vendor for deliveries and re-supply, and disposing of expired kits. Results: Disease site groups were transitioned to the CCRU Kit Squad stepwise from Oct 2016 to Dec 2017 (15-mos), which included 80 nurses, 16 disease site groups, and over 400 clinical trials. By the end of 2017, the average number of kits ordered per day, and per month were 33 and 1003, respectively. Conclusions: The CCRU Kit Squad developed a centralized online service for kit management, thereby reducing administrative burden on clinical trial nurses. It has streamlined the management of biospecimen kits, eliminated wasted space in clinical areas, and facilitated the selection of the right kit for the right test at the right time.

Results of an Oncology Clinical Trial Nurse Role Delineation Study.

To evaluate the relevance of a five-dimensional model of clinical trial nursing practice in an oncology clinical trial nurse population. . Web-based cross-sectional survey. . Online via Qualtrics. . 167 oncology nurses throughout the United States, including 41 study coordinators, 35 direct care providers, and 91 dual-role nurses who provide direct patient care and trial coordination. . Principal components analysis was used to determine the dimensions of oncology clinical trial nursing practice. . Self-reported frequency of 59 activities. . The results did not support the original five-dimensional model of nursing care but revealed a more multidimensional model. . An analysis of frequency data revealed an eight-dimensional model of oncology research nursing, including care, manage study, expert, lead, prepare, data, advance science, and ethics. . This evidence-based model expands understanding of the multidimensional roles of oncology nurses caring for patients with cancer enrolled in clinical trials.

The role of the research nurse in clinical trials

Clinical trials are one of the important tools leading to progress in health care and a part of clinical practice. Indispensable support to research teams is provided by research nurses responsible for managing the care for subjects enrolled in clinical trials. The objective was to assess the actual job duties of general nurses participating in clinical trials and to identify the main obstacles and expectations from their point of view. A method of questionnaire survey administered to a selected group of respondents was used. Eight teaching hospitals and two specialized centres in the Czech Republic were approached that are currently carrying out clinical trials. Eight health care providers participated in the survey. Of the total of 10,603 general nurses working at the eight facilities involved in the study, 203 nurses working in research participated in the survey. The data analysis revealed insufficient education in research being the main shortage and limitation for research nurses (74.4%). The majority of nurses were expected to develop professionally when being involved in clinical trials (69.0%). No difference was established in expectations as far as the socio-demographic characteristics of respondents were concerned (p≥0.05). Nurses having attended GCP (Good Clinical Practice) courses perceived their work as more time consuming (p=0.022). The results of the survey have shown that the framework job description of research nurses in clinical trials is insufficiently prepared. The key practical outcome of the study will be educational recommendations and the initiation of a professional discussion on the governmental level on the legislative definition of the position of research nurses in Central Europe and the Czech Republic.

1721 Multidisciplinary clinical decision making in colorectal cancer teams: A mixed method, multi stage investigation into the contribution of the clinical nurse specialist within the multidisciplinary team meeting

s S255 Methods: Research nursing staff drew a list with nursing activities required by trials. Afterwards, the Core Activities identified were timed by an outside observer during daily practice. All data were recorded in a database to calculate the meantime for each activity which allowed us to define the standard coefficient (SC) that could be registered in the “Nursing Time Required by Clinical Trial − Assessment Tool” (NTRCT-AT). Results: The population was composed by seven Italian Clinical Trial Nurses, with a mean age of 34 years. Nursing staff identified 30 core activities and their standard coefficient that constitute the NTRCT-AT. It is an Excel table where the protocols’ flowchart can be translate in minutes of time nursing work. Conclusion: The instrument NTRCT-AT can be used to evaluate the time needed for nurse activities in clinical trial and is useful to assess the workload of clinical research nurses. Cancer clinical trials continue to increase in complexity and research nurses have in charge most of the activities that constitute a clinical study. The assessment of the correct balance between number of professionals and number of trials is essential to ensure patients safety and data quality. No conflict of interest.

Role of research in urgent care.

Julia Grahamslaw explains why the greater involvement of emergency nurses in clinical trials can save patients’ lives

Nursing Contributions in Community Clinical Oncology Research Programs

To describe the Community Clinical Oncology Programs (CCOPs), identify the roles and functions of CCOP nurses in clinical trials, and discuss the future contributions of nurses in the National Cancer Institute (NCI) Community Oncology Research Program. Research and review articles, Web sites, and government reports. The contribution of nurses in the community clinical research setting has not been defined or quantified; however, examination of the literature reveals substantial contributions from nurses in the conduct and dissemination of oncology research. Nurses outside of academic settings must be as well versed in new research as those in large institutions. Education on clinical trials and oncology research is necessary in the treatment and care of cancer patients. Experienced community-based nurses are essential to the success of the NCI Community Oncology Research Program.