SARS-Cov-2 and Cancer Trials Ireland: Impact, resolution, legacy

Background: The SARS-Cov-2 pandemic led to significant ongoing disruptive change in healthcare from 3/2020 to the present. The impact and legacy on a national clinical trials organisation was assessed. Methods: A review was conducted of prospectively acquired communications, team logs and time sheets, trial activation, closure, and accrual, for the period 2019-present. An online survey of the impact of the pandemic on clinical investigators was performed. During lock-down periods hospital sites closed to monitoring visits and remote visits were not always possible due to paper- based health information systems. Overall accrual to academic cancer clinical trials decreased by 49%. Results: In the 9 months after the pandemic was declared clinical trial accrual fell by 54%, radiotherapy trial accrual by 90% and translational studies by 36%. Staff reassignment occurred in 60% of units. Monitoring visits by Clinical Research Associates was reduced by 42% and remote monitoring rose from 5% to 20% of monitoring visits. The opening of new trials fell by 67%. 77% of investigators experienced burnout, 71% had less time for trials and 53% reported less support for trials. Conclusions: The pandemic has had a significant negative impact on cancer clinical trial activity in Ireland with a notable decline in academic-led trial activity compared to pharmaceutical-led trials. Protected staff assignments, electronic records to facilitate remote monitoring and enhanced support for clinical trials staff is needed to increase resilience in the system. Legal entity responsible for the study: Cancer Trials Ireland. Funding: Cancer Trials Ireland. Disclosure: The author has declared no conflicts of interest.