Assessing the Impact of COVID-19 on Clinical Trials within Neurology

ABSTRACT

Objective: To investigate the impact of the COVID-19 pandemic on clinical trials in the field of neurology. Background: The COVID-19 pandemic and initiatives to curtail its spread disrupted the conduction of clinical research, forcing reimagination of the existing frameworks to execute scientifically sound human subjects research. In this study, we quantify the impact of the pandemic on clinical trial initiation and trial withdrawal in the field of neurology. Design/Methods: We used the largest publicly available database of clinical trials, clinicaltrials.gov, to compute the annual rate of change in clinical trial initiation and withdrawal in the field of neurology from January 2010 to December 2020 compared to the anticipated rate. Results: Our analysis showed a significant decrease in neurology clinical trial initiation in 2020 compared to pre-pandemic years [decrease by 12.4% in 2020 contrasted with the projected 9.7% overall increase (p < 0.0001)]. Significant decreases were maintained across all analyzed neurological subspecialties and study phases, except for combined Phase II/Phase III. Early Phase I (observed = -39.6%, expected = +37.3%, p < 0.05) and Phase I studies (observed = -20.4%, expected = +3.8%, p < 0.05) saw the greatest decreases. Study subtype analysis also revealed significant decreases in both interventional (observed = -12.4%, expected = +9.5%, p < 0.001) and observational studies (observed = -13.6%, expected = +10.3%, p < 0.01). In the analyzed time period from 2010 to 2020, 2020 was the only year demonstrating trial initiation declines compared to the preceding year. Conclusions: Our analysis demonstrated a significant reduction in neurology clinical trial initiation in the 2020 calendar year when compared to prior years, and that this pattern was seen across clinical research in neurology subspecialties. These data further demonstrate the inclusion of human subjects research in neurology as another consequence of SARS-CoV-2.