Table 1.
Research response | COVID-19 | Non-COVID-19 conditions |
---|---|---|
Clinical trial priorities | Anti-viral treatment protocols prioritized | Resources redirected |
Regulatory and Institutional Review Board | Expedited preparation, review and approval | Sponsors and sites rapidly developed and approval received for remote trial conduct |
Sponsor and financial management | Accelerated contracts and budget | Resources redirected to support participant outreach and to deploy technologies for remote trial conduct |
Study timelines | First participant enrolled <1 week from protocol receipt | Enrolment periods extended if in-person visit required |
Investigators and coordinators | Multi-specialty team: infectious disease, pulmonary–critical care, hospital medicine, nephrology and cardiology | Roles and responsibilities: team ethos, flexibility and cross-training |
Patient access and on-study culture | A study for every patient: daily huddle for case review; remote consenting; consenting by legally authorized representative; informed consent forms translated into five languages to match patient demographics | Sustain engagement: frequent outreach; provide updates; answer questions; address concerns; remote technologies for study participation; survey about experiences and perspectives for study conduct |
COVID-19-related considerations | Portfolio: interventional treatments for full spectrum of patients; observational studies for epidemiology; biobanking; serology testing | Study conduct: missed visits and data; interruption of study treatment; protocol deviations; adverse events; impact on key outcomes |
COVID-19, coronavirus disease 2019.