ABSTRACT
The COVID-19 pandemic forced a redesign of clinical research to adapt to an ever-changing situation while minimizing patient and provider risks and preserving scientific discovery. During the initial surge of COVID-19, elective healthcare services and non-critical research operations were halted. These changes inspired dispersed health care operations and streamlined clinical research. The first wave of COVID-19 hit Detroit, Michigan, in March 2020, consuming Henry Ford Health (HFH), in COVID-19 emergency care. HFH has a clinically integrated liquid biopsy (LB) program where enrolled patients provide an LB sample via venipuncture within 7 days of each MRI, typically in the clinic at the point-of-care. Prior to COVID-19, 183 neurooncology patients were actively providing LB samples in clinic with a mean of 29.9 specimens monthly. Institutional COVID-19 restrictions on noncritical interactions resulted in months were nearly all outpatient encounters utilized telemedicine and decentralized testing off-site from research operations. This halted LB procurement to 4.55 specimens monthly during early pandemic months. To reduce patient-provider exposure, LB specimens were then procured with the venipuncture for MRI which streamlined LB operations and improved the patient experience. After this change, LB specimen procurement returned to near pre-pandemic levels with a mean of 28.1 monthly specimens, despite a significant population utilizing video visits and imaging at satellite or non-HFH centers. The pandemic forced adaptations to patient encounters that have changed how healthcare is delivered, resulting in parallel changes in research that must be considered in the design of future studies.
ABSTRACT
Objective: 1. N/A 2. Background: In the wake of the Coronavirus disease outbreak (COVID-19), clinical trial operations were significantly impacted following the shutdown of elective healthcare services and, in some cases, emergency operations. When the pandemic hit Detroit, Michigan in March 2020, the Hermelin Brain Tumor Center (HBTC) at Henry Ford Health System was consumed in COVID-19 emergency care which affected patient enrollment, conduct of trial activities, therapeutic treatment, deviation from protocol requirements, and sponsor-study site contact. The first Metro-Detroit COVID-19 case was confirmed March 10th 2020. At that time there were 18 active brain tumor clinical trials (phase 1 - 3) providing anti-cancer therapies. Design/Methods: Modifications included decentralized operations to buildings with clinic and radiology access away from inpatient COVID-19 care, utilization of telemedicine for nonessential visits, shipping of investigational products to patient home, and in some cases utilization of local results in place of central histopathological confirmation. By April 2020, trials were ranked based on availability of alternate therapies and subject safety in 4 tiers that correlated with subject benefit and impact on care. Trials were given a prioritization level to commence enrollment with priority given to trials where no standard of care exists. Of the HBTC trials, one was graded Tier 1 and most were graded Tier 2. All patients already enrolled, continued study participation. As restrictions eased, trials were opened in a sequential manner. Results: N/A Conclusions: Changes that were made during the first wave of the pandemic helped to minimize its effect on clinical trial operation and enrollment during the second wave in Fall 2020. Thus, leading toward a decrease in trial deviations and increased enrollment during the 2 wave. Changes made during the first wave helped to safely continue enrollment and treatment during the second wave and will have a longstanding impact on how clinical trials are conducted in the future.