Quantifying the impact of the COVID-19 pandemic on cancer center clinical trial operations.

BACKGROUND: Oncology clinical trials are complex, and the COVID-19 pandemic caused major disruptions in 2020. METHODS: Using its networking and sharing of best practices, the Association of American Cancer Institutes, comprising 105 cancer centers, solicited a longitudinal series of voluntary surveys from members to assess how clinical trial office operations were affected. The surveys showed that centers were able to keep oncology trials available to patients while maintaining safety. Data were collected regarding interventional clinical trial accruals for the calendar years 2019, 2020, and 2021. RESULTS: Data demonstrated a sizeable decrease in interventional treatment trial accruals in both 2020 and 2021 compared with prepandemic figures in 2019. No cancer center reported an increase in interventional treatment trial accruals in 2020 compared with 2019, with most centers reporting a moderate decrease. In mid-2022, 15% of respondents reported an increasing trend, 31% reported no significant change, and 54% continued to report a decrease. CONCLUSIONS: The pandemic necessitated rapid adoption of trial operations, with the emergence of several best practices, including remote monitoring, remote consenting, electronic research charts, and work-from-home strategies for staff. The national infrastructure to conduct trials was significantly affected by the pandemic, with noteworthy resiliency, evidenced by improvements in efficiencies and patient-centered care delivery but with residual capacity challenges that will be evident for the foreseeable future.

Clinical Trial Metrics: The Complexity of Conducting Clinical Trials in North American Cancer Centers.

PURPOSE: Cancer clinical trials offices (CTOs) support the investigation of cancer prevention, early detection, and treatment at cancer centers across North America. CTOs are a centralized resource for clinical trial conduct and typically use research staff with expertise in four functional areas of clinical research: finance, regulatory, clinical, and data operations. To our knowledge, there are no publicly available benchmark data sets that characterize the size, cost, volume, and efficiency of these offices, nor whether the metrics differ by National Cancer Institute (NCI) designation. The Association of American Cancer Institutes (AACI) Clinical Research Innovation (CRI) steering committee developed a survey to address this knowledge gap. METHODS: An 11-question survey that addressed CTO budget, accrual and trial volume, full-time equivalents (FTEs), staff turnover, and activation timelines was developed by the AACI CRI steering committee and sent to 92 academic cancer research centers in North America (n = 90 in the United States; n = 2 in Canada), with 79 respondents completing the survey (86% completion rate). RESULTS: The number of FTE employees working in the CTOs ranged from 4.5 to 811 (median, 104). The median number of analytic cases (ie, newly diagnosed or received first course of treatment) reported by the main center was 3,856. Annual CTO budgets ranged from $250,000 to $23,900,000 (median, $8.2 million). The median trial activation time, based on 61 centers, was 167 days. The median number of accruals per center was 480 (range, 5-6,271) and median number of trials per center was 282 (range, 31-1,833). Budget and FTE ranges varied by NCI designation. CONCLUSION: The response rate to the survey was high. These data will allow cancer centers to evaluate their CTO infrastructure, funding, portfolio, and/or accrual goals as compared with peers. A wide range in each of the outcomes was noted, in keeping with the wide variation in size and scope of cancer center CTOs across the United States and Canada. These variations may warrant additional investigation.

Using Rapid Cycle Improvement (Plan, Do, Study, Act) to Design a Scalable Appointment Scheduling System for Complex Oncology Clinical Trials at an Academic Cancer Center.

PURPOSE: This study's purpose was to optimize the efficiency of and to design a scalable research scheduling team to meet the growing demands of an academic cancer center with increasing clinical trial accruals. METHODS: The Plan, Do, Study, Act improvement methodology was deployed to increase the efficiency of research scheduling, to reduce non-value-added (NVA) activities, and to reduce cycle time to meet takt time. In the Plan phase, voice-of-the-customer interviews were conducted. In the Do phase, the baseline workflow was mapped and billing data were analyzed. In the Study phase, cycle time, takt time, and capacity analysis metrics were calculated at baseline. In the Act phase, interventions were implemented to increase efficiency by reducing NVA activities and increasing value-added activities, and metrics were reassessed after intervention. RESULTS: An 8% increase in appointment requests was noted from baseline to after intervention, and the cycle time for appointment scheduling decreased by 11%, demonstrating increased efficiency. Process steps decreased from 15 to 10, eliminating NVA activities and rework and waiting, two types of waste. CONCLUSION: Although efficiency increased, the number of total appointments scheduled weekly increased by 4%, resulting in a reduced takt time, or a shorter time to schedule each appointment to meet demand. A capacity analysis demonstrated that even after interventions, an additional 0.5 full-time employee is required to reduce cycle time to equal takt time. Capacity analysis creates a scalable framework for the scheduling team and facilitates movement from reactive to proactive staffing, which can be applied throughout the research enterprise.