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

BACKGROUND: Clinical 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. METHODS: Nineteen nurses participated in semi-structured one-to-one interviews and data analysis was based on Colaizzi's method. RESULTS: CRNs 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. CONCLUSION: Diversity 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.

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

ABSTRACT: 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 role of clinical research nurses in minority recruitment to cancer clinical trials.

Clinical trials (CTs) are the established research mechanism designed to examine how new medical therapies are tested for safety and effectiveness. Specifically, non-Hispanic White patients still account for most CT participants and Black patient participation has declined over the past decade. Clinical Research Nurses (CRNs) whose scope of practice includes the recruitment of participants for CTs, have the potential to significantly increase minority patients participation in cancer clinical trials (CCTs). The aim of this phenomenological study was to describe adult oncology CRNs' lived experiences of recruiting minority cancer patients to participate in CTs. A total of 19 nurses participated in semi-structured one-to-one interviews and data analysis was based on Colaizzi's method. The role of CRNs was described as advocates who coordinate care, establish trust, and provide education for CT patients within physician-driven recruitment structures. The CRN's role was also described as self-taught or learn on the go with no formalized recruitment training and lack of robust cultural training. To achieve diverse patient enrollment in CCTs, CRNs and study staff need to receive training on culturally competent clinical research care and the diversity of CRNs and study teams must be increased. Further, meaningful federal and hospital policy change must occur so that minority patients have equitable access to novel cancer therapies and the role of the CRN is delineated from other healthcare staff to optimize research patient care.

The Impact of COVID-19 on Clinical Trial Execution at the Dana-Farber Cancer Institute.

Interventions designed to limit the spread of coronavirus disease 2019 (COVID-19) are having profound effects on the delivery of health care, but data showing the impact on oncology clinical trial enrollment, treatment, and monitoring are limited. We prospectively tracked relevant data from oncology clinical trials at Dana-Farber Cancer Institute from January 1, 2018, to June 30, 2020, including the number of open trials, new patient enrollments, in-person and virtual patient visits, dispensed investigational infusions, dispensed or shipped oral investigational agents, research biopsies, and blood samples. We ascertained why patients came off trials and determined on-site clinical research staffing levels. We used 2-sided Wilcoxon rank sum tests to assess the statistical significance of the reported changes. Nearly all patients on interventional treatment trials were maintained, and new enrollments continued at just under one-half the prepandemic rate. The median number of investigational prescriptions shipped to patients increased from 0 to 74 (range = 22-107) per week from March to June 2020. The median number of telemedicine appointments increased from 0 to 107 (range = 33-267) per week from March to June 2020. Research biopsies and blood collections decreased dramatically after Dana-Farber Cancer Institute implemented COVID-19-related policies in March 2020. The number of research nurses and clinical research coordinators on site also decreased after March 2020. Substantial changes were required to safely continue clinical research during the pandemic, yet we observed no increases in serious adverse events or major violations related to drug dosing. Lessons learned from adapting research practices during COVID-19 can inform industry sponsors and governmental agencies to consider altering practices to increase operational efficiency and convenience for patients.