Challenges Potential reason(s) Potential consequence(s)
Workforce-related
Reduced clinical research workforce
Contract COVID-19 Reduced staff (furloughs, job loss) Work from home mandates Delay in patient recruitment Delays data collection and submission Potential compromise in data quality
Reduced laboratory research workforce
Contract COVID-19 Reduced staff (furloughs, job loss) Work from home mandates Exclusion of trainees due to social distancing Little to no laboratory research being performed beyond “essential” Delays in publications, grant submissions, report deadlines due to incomplete data Delayed or compromised training of future workforce
Reduced capacity of institutional review board (IRB)
Reduced staff (furloughs, job loss) Work from home mandates More protocol amendments Influx of COVID-19-related protocols Deferred or prolonged new protocol review Prolonged review of protocol amendments
On-site monitoring suspended
Sponsor (furloughs, job loss, work from home mandates)
Reduced interaction with sponsor Less sponsor oversight, increased data errors
Consent process by phone Phone consent Compromised patient understanding especially low socio-economic status patients
Research
Observational research (natural history) Deemed nonessential Gaps in registry patient data
Biorepository databases Deemed nonessential Less patient biospecimens
Phase I and II trials Suspended Less treatment options for patients with relapsed, refractory disease
Reduced clinical revenue from hospital Decreased patient volumes Furloughed or permanent loss of clinical research workforce
Funding
Institutional Reduced patient care volumes, budget Slower discovery and delayed impact on patients
Government Limited or reallocated resources Slower discovery and delayed impact on patients
Philanthropic Reduced funding due to lower donations Slower discovery and delayed impact on patients