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.
ABSTRACT
SWOG Cancer Research Network, part of the National Cancer Institute's National Clinical Trials Network and the National Cancer Institute Community Oncology Research Program, designs and conducts clinical trials to improve the lives of people with cancer. Trial designs are Phase 2, 2/3 and 3 as well as observational cohorts and focus on cancer treatment or on supportive care, symptom management, cancer care delivery, or cancer control. Approximately 4000 patients are put on SWOG trials annually by study sites across all 50 states as well as by international sites;currently, there are 90 active trials. The COVID-19 pandemic forced SWOG to pivot to address the large range of issues facing the study sites that put patients on its trials, as well as required the group to track the impact of the pandemic on its trials. Information was flowing from a variety of sources and we needed to quickly respond, as well as efficiently distribute the information to study sites, who themselves were burdened with pandemic-related staffing and process issues. National Cancer Institute guidance to sites addressed concerns regarding patient safety and minimizing patient risk. Procedures for obtaining informed consent remotely, the distribution of study drug, and the use of telehealth visits were among the issues addressed. SWOG provided protocol-specific guidance regarding timing of specified activities including allowable registration windows, timing of labs, and collection of specimens and patient-reported outcomes. SWOG created new reports to monitor accrual, developed, and deployed a form to collect National Cancer Institutemandated COVID-specific data, provided study sites with information on the specimen repositories ability to receive and process biological trial samples, as well as a prioritized, study-specific list of specimen requirements. Other changes included a switch to remote Quality Assurance audits and adjustments to how sites were monitored regarding submission of data and specimens. New internal data management processes for the remote work environment were implemented. Because of the volume of information, SWOG rapidly launched a clearinghouse on SWOG's website (swog.org) to centrally compile real-time COVID-19 resources, news, and information, including the general guidance documents from SWOG, the National Cancer Institute, its Central institutional review board, and the Food and Drug Administration. Protocol-specific memoranda were issued for 22 SWOG trials. The semi-annual SWOG Group Meeting scheduled for April 2020 was switched to a remote meeting as were the subsequent two meetings and other trainings and seminars. Even with all the changes, 14 new trials were activated in 2020 and 107 journal articles published. Accrual was impacted differentially by disease area, study phase, and trial type. SWOG staff across multiple offices worked together to modify and adjust processes so that site staff could continue to offer the highest quality clinical trials and care for cancer patients amid a public health emergency. In our presentation, we will discuss lessons learned and the impact of the pandemic on the future of clinical trials.