Abstract
Oncology advanced practitioners (OAPs) play an important role in cancer care delivery. However, leadership in clinical research remains low among OAPs. Although OAPs often participate in patient care for early-phase clinical trials, they rarely have the opportunity to lead as a principal investigator (PI), despite being capable and effective PIs when provided education and mentoring. As cancer care needs continue to increase, there is a critical need for well-trained PIs and sub-investigators (sub-Is) to evaluate novel therapeutics. To address this need, an intensive 3.5-day educational course at HonorHealth Research Institute (HRI) was developed to provide education and guidance to OAPs who desire to learn and evolve into the role of a PI in clinical trials. The course involved lectures, roundtable discussions with physicians, and protocol synopsis workshops. Participants included 21 OAPs. Participants were given questionnaires to evaluate the impact of the course and assess knowledge retention. In lectures, 65% of questions answered demonstrated improvement. In course evaluations, 100% of participants agreed that the learning objectives were met. In follow-up surveys, 63% reported they had reviewed their drafted protocol synopsis with their mentor, while the majority felt at least somewhat confident that they would be able to move forward with their protocol synopsis. Overall, participants responded favorably to the course, which successfully provided foundational knowledge for OAPs to transition into clinical research leadership positions.
References
Braun-Inglis, C., Boehmer, L. M., Zitella, L. J., Hoffner, B., Shvetsov, Y. B., Berenberg, J. L., Oyer, R. A., & Benson, A. B. (2022). Role of oncology advanced practitioners to enhance clinical research. Journal of the Advanced Practitioner in Oncology, 13(2), 107–119. https://doi.org/10.6004/jadpro.2022.13.2.2
Cavallo, J. (2024). Tackling the challenges of oncology workforce shortages, increased patient demand, and rising costs of care. Ascopost.com. https://ascopost.com/issues/january-25-2024/tackling-the-challenges-of-oncology-workforce-shortages-increased-patient-demand-and-rising-costs-of-care/
Centers for Disease Control and Prevention and National Cancer Institute. (2024). USCS Data Visualizations. Gis.cdc.gov. https://gis.cdc.gov/Cancer/USCS/#/Trends/
Code of Federal Regulations. (2025). Code of Federal Regulations a point in time ECFR system. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-812/subpart-C/section-812.43
Downhour, M. (2018). Opinion: Approaches to set up principal investigators for success. Clinical Researcher, 32(6). https://acrpnet.org/wp-content/uploads/dlm_uploads/2018/06/CR-June-2018_full-issue.pdf
Jameson, G. S., Borazanci, E., Babiker, H. M., Poplin, E., Niewiarowska, A. A., Gordon, M. S., Barrett, M. T., Rosenthal, A., Stoll-D’Astice, A., Crowley, J., Shemanski, L., Korn, R. L., Ansaldo, K., Lebron, L., Ramanathan, R. K., & Von Hoff, D. D. (2020). Response rate following albumin-bound paclitaxel plus gemcitabine plus cisplatin treatment among patients with advanced pancreatic cancer: A phase 1b/2 pilot clinical trial. JAMA Oncology, 6(1), 125–132. https://doi.org/10.1001/jamaoncol.2019.3394
National Center for Health Workforce Analysis. (2024). State of the U.S. Health Care Workforce, 2024. https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/state-of-the-health-workforce-report-2024.pdf
Vogel, W. H. (2016). Oncology advanced practitioners bring advanced community oncology care. American Society of Clinical Oncology Educational Book, 36, e97–e100. https://doi.org/10.1200/EDBK_158751