ABSTRACT
Background: Severe shortages in clinical trial staffing across the United States and internationally has been anecdotally noted, but data are lacking. To better assess the scope and impact of staffing shortages, SWOG conducted a Cooperative Group-wide survey of Oncology Research Professionals (ORP). Methods: The survey was developed by SWOG leadership and was granted an IRB exemption by Lifespan IRB (Providence, RI). The survey was disseminated by email in January 2022 to Head Clinical Research Associates (CRAs, n = 100) using an inclusive distribution list that goes to the site-identified administrative leader of each SWOG Member and National Community Oncology Research Program institution. The data were collected and managed using REDCap electronic data capture tools hosted at Lifespan. Descriptive statistics were performed and qualitative analysis conducted to identify major themes. Results: The response rate was 87% and 41 of 87 respondents completed the full survey (47%). The majority of respondents were female (89.6%), not Hispanic (87.8%) and White (85.1%). The proportion that identified as Hispanic or Asian was 12.8 and 6.9%, respectively. One participant identified as Black and another as American Indian/Alaskan native. The most common work setting was within an academic medical center (47.9%) and 57.8% held a management or leadership role at their institutions. The majority (79%) used an Institutional IRB for trials not overseen as part of the National Clinical Trials Network. Over 80% of respondents reported their institution is experiencing a personnel shortage due to COVID-19. Proportion who reported this negatively impacted IRB processes was 50%, financial review was 42%, and legal review was 26.9%. On a scale of 0 (none) to 6 (significant), the impact was most significant on audit activities and accrual to trials (both rated 5), transfer of data to sponsors and sponsor visits (both rated 4.5);all other aspects rated a 4, including screening procedures, regulatory activities, and data collection. Ranked reasons for attrition were desire for better pay, seeking better opportunities, and seeking more flexible working conditions. General burn out was ranked as the fourth most common cause. Important themes included increasing trial complexity, morale, lack of support (due to staff shortages), lack of opportunities for promotion, unfilled positions, and the lack of experience of new hires. Conclusions: Over 80% of research programs affiliated with SWOG report staffing shortages due to the COVID-19 pandemic and the impact of these shortages touch every aspect of clinical research. Initiatives to recruit, train, and retain staff are urgently needed. As in other areas of medicine (e.g. hospital nursing), the potential for post-pandemic persistence of this issue requires an immediate national response.