Table 1 Clinical research responses to the COVID-19 pandemic

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