Rapidly adapting the clinical research environment at an NCI-designated comprehensive cancer center to the COVID-19 pandemic.

Abstract

e13534 Background: In March 2020, responding to COVID-19, the Columbia University Institutional Review Board (IRB) mandated all research pause in-person activities except studies “offering the potential for direct benefit” to patients. New enrollment was also paused. Columbia University Irving Medical Center concurrently mandated all non-essential employees work remotely, and all feasible patient visits transition to telehealth. The clinical research infrastructure at the Herbert Irving Comprehensive Cancer Center (HICCC) was required to adapt its operations in response. Methods: The HICCC convened an executive committee (EC), consisting of multi-disciplinary leadership, canvassed peer institutions, and engaged the IRB Executive Director (ED), Chief of Infectious Disease, a bioethicist, and others ad hoc. Results: The IRB ED agreed with the EC that all approved interventional therapeutic clinical trials for cancer (n = 554) offered the potential for direct benefit to patients. The EC established an “Emergency Preparedness” standard operating procedure (SOP) with input from the IRB and HICCC Protocol Review & Monitoring and Data & Safety Monitoring Committees. This SOP required assessment of each protocol for risks/benefit, transition to remote processes when possible, and referenced the Code of Federal Regulations allowing changes to a research plan without prospective IRB-approval if “necessary to eliminate apparent immediate hazard”. For new subjects, the EC created a process for enrollment as exceptions to the research pause requiring written justification by the PI that included risk-mitigation strategies and approval by the EC. 116 patients were accrued under this process. All external monitoring and auditing was transitioned to remote. Finally, 25% of research nurses and 10% of coordinators were redeployed to other short-staffed areas of the medical center. After 3 months, the IRB lifted the research pause in tranches, and the EC charged its Disease Based Teams with prioritizing trials to reopen. Accrual nadired at 30% of pre-pandemic levels in June 2020, which fully recovered by March 2021. Conclusions: A centralized research infrastructure working closely with established institutional committees was critical for the unprecedented yet effective and rapid ramp down/up of clinical trials. After 1-year, accrual recovered to pre-pandemic levels, leveraging new processes such as electronic consent, telehealth, and remote work for staff.