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.
ABSTRACT
BACKGROUND: The COVID-19 pandemic has created enormous challenges for the clinical management of patients with hematological malignancies (HMs), raising questions about the optimal care of this patient group. METHODS: This consensus manuscript aims at discussing clinical evidence and providing expert advice on statements related to the management of HMs in the COVID-19 pandemic. For this purpose, an international consortium was established including a steering committee, which prepared six working packages addressing significant clinical questions from the COVID-19 diagnosis, treatment, and mitigation strategies to specific HMs management in the pandemic. During a virtual consensus meeting, including global experts and lead by the European Society for Medical Oncology and the European Hematology Association, statements were discussed and voted upon. When a consensus could not be reached, the panel revised statements to develop consensual clinical guidance. RESULTS AND CONCLUSION: The expert panel agreed on 33 statements, reflecting a consensus, which will guide clinical decision making for patients with hematological neoplasms during the COVID-19 pandemic.