While every organization is unique and will need to tailor research operations to their situation, below are practical strategies that cancer programs can deploy to position themselves for a successful pandemic recovery.
» Keep following announcements from federal agencies on managing clinical studies; inform investigators and study teams about new guidance.
» Use remote consent, telehealth, or mobile nursing visits for clinical oncology studies that can be managed virtually.
» Ensure administration is documenting protocol modifications by sponsor and updating study teams. Continue documenting all protocol deviations as trial participants return for care but adapt site visits, contracting, and drug distribution when there are noncompliance issues. Report major protocol deviations to appropriate IRBs.
» Monitor study team workload and consider changes (e.g., centralizing clinical research, creating dedicated backup teams).
» Coordinate with infection control to document handling precautions for samples of COVID-19-infected and noninfected patients. Biospecimens from infected patients should have clearly documented procedures around collection, processing, and disposal.
This is part of the COVID-19 oncology response series from ECG Management Consultants. For more information, visit ECG’s website.
Leave a Reply