ABSTRACT
Background: Clinical Research Nurses (CRNs) care for study participants and manage clinical research studies; yet the CRN practice role is rarely covered in undergraduate nursing curricula in the United States. Despite a burgeoning need for CRNs, the pipeline of clinical research nurse positions remains sparse. The International Association of Clinical Research Nurses's (IACRN) strategic goal to "engage with nursing schools to heighten awareness and inclusion of the CRN role competencies in nursing education" prompted the development of an educational lecture module to be disseminated to nursing schools. This project is a pilot launch of the module. Methods: A task force of IACRN was formed to develop educational materials that could be used as outreach to undergraduate nursing schools. The content included a slide presentation covering an overview of clinical research, the CRN practice, three embedded videos showing CRN and study participant perspectives, and coverage of the care of participants of research by staff nurses. Due to COVID-19 we revised our live lecture approach using either a live synchronous webinar presentation, or an embedded asynchronous course module with YouTube videos for course learning management systems. We presented the content to 408 nursing students attending three academic programs. To evaluate effectiveness and satisfaction, an anonymous, post-presentation survey using web-based QualtricsXM was distributed to students. Results: Content and delivery of the module was positively evaluated. There was an improvement in knowledge in each topic. Evaluation responses showed that the content could likely or very likely improve care for their patients (87.4%) and improve patient education for patients in clinical trials (95%). Conclusions: Delivering a synchronous or asynchronous module about the CRN practice role to nursing students in academic nursing programs is valuable to increasing awareness of the care of patients in clinical trials, the CRN role, and future professional development.
ABSTRACT
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.