The SARS-CoV-2 Pandemic and Cancer Trials Ireland: Impact, Resolution and Legacy †

SIMPLE SUMMARY: The SARS-CoV-2 pandemic led to a significant disruption to healthcare. Cancer Trials Ireland is the national cooperative cancer trials organisation in Ireland. We analysed the impact of the pandemic on the conduct of cancer clinical trials over a 2 year period. Clinical trial accrual fell by 54%, with trials in radiotherapy being most affected, declining by 90%. This reduction was due to reduced staffing, delays in trial logistics and halting of accrual and initiations due to safety concerns. Remote monitoring of trials increased. Protocol violations increased due to interruption of visits and diagnostic testing. The impact on accrual persisted for at least 18 months. Significant central office staffing issues were evident with recruitment and retention. A retreat was conducted to identify the transformative changes that were needed to build resilience in clinical trial conduct. Adaptive strategies in trial conduct such as expanded telehealth and tele-monitoring, flexibility of trial scheduling, protected staff assignments, and mentoring of research staff were identified as priorities for the recovery stage of the pandemic. ABSTRACT: Background: Cancer Trials Ireland (CTI) is the national cooperative group in Ireland. The SARS-CoV-2 pandemic led to significant ongoing disruptive change in healthcare from March 2020 to the present day. Its 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 to September 2021. An online survey of the impact of the pandemic on clinical investigators and of clinical trials units was performed. A National Cancer Retreat was organised on 21 May 2021 to identify and address pandemic related disruption and develop adaptive strategies. Results: In the weeks after the pandemic was declared, remote working was initiated by all central office staff. Nationally, clinical trial accrual fell by 54% compared to the same period in 2019, radiotherapy trial accrual by 90%, and translational studies by 36%. Staff reassignment of research nurse staff occurred in 60% of units, trial monitoring was reduced in 42%, and trial initiations fell by 67%. Extreme fluctuations in monitoring hours were noted paralleling lockdown measures. Significant impact on all clinical trials units was noted including staff reassignments, reduced access to diagnostic imaging and reduced institutional supports. Remote clinic visits and remote monitoring was widely adopted. The National Cancer Retreat identified flexibility in trial conduct, staff recruitment and retention, the need for harmonisation of processes, and research staff support in the context of remote working as priorities. Conclusion: The pandemic has had a significant ongoing negative impact on cancer clinical trial activity in Ireland. Adaptive strategies including trial flexibility, expanded telehealth and remote monitoring, harmonisation of processes and staff support have been identified as priorities to ameliorate this impact, and develop a more sustainable clinical trial ecosystem.