Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Apr 30;14(9):2247.
doi: 10.3390/cancers14092247.

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

Seamus O'Reilly  1   2 , Verena Murphy  1 , Eibhlin Mulroe  1 , Lisa Tucker  1 , Fiona Carragher  1 , Jacinta Marron  1 , Aoife M Shannon  1 , Ken Rogan  1 , Roisin M Connolly  2 , Bryan T Hennessy  1 , Ray S McDermott  1
Affiliations

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

Seamus O'Reilly et al. Cancers (Basel). .

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.

Keywords: COVID-19; clinical trials; transformative change.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Impact on clinical trial accrual 2019–2021. (A) Clinical trial accrual January to June; (B) clinical trial accrual January to December.
Figure 2
Figure 2
A representative CTRIAL-IE study before and during the pandemic, highlighting the effect of the pandemic (and Brexit) on level of staff resource hours for trial management (x-axis: staff hours, y-axis: years in quarters) Green and grey circled tasks: regular trial related work; red circled tasks: stressors resulting in increased work hours.
Figure 3
Figure 3
Monitoring activity in person (MV) and remotely (RV) by CTI central office staff, per 6 month period.
Figure 4
Figure 4
(a) Paired assessment of protocol deviations of studies open to accrual in 2019 and 2020; (b) categories of protocol deviations observed.
See this image and copyright information in PMC

References

    1. McLaughlin R.A., Madigan V., O’Grady M., Korpanty G., Coate L. The impact of the COVID-19 pandemic on oncology clinical trials. Ir. Med. J. 2020;113:1–7.
    1. Burke S., Parker S., Fleming P., Barry S., Thomas S. Building health system resilience through policy development in response to COVID-19 in Ireland: From shock to reform. Lancet Reg. Health-Eur. 2021;9:100223. doi: 10.1016/j.lanepe.2021.100223. - DOI - PMC - PubMed
    1. Cazelles B., Nguyen-Van-Yen B., Champagne C., Comiskey C. Dynamics of the COVID-19 epidemic in Ireland under mitigation. BMC Infect. Dis. 2021;21:735. doi: 10.1186/s12879-021-06433-9. - DOI - PMC - PubMed
    1. Kennelly B., O’Callaghan M., Coughlan D., Cullinan J., Doherty E., Glynn L., Moloney E., Queally M. The COVID-19 pandemic in Ireland: An overview of the health service and economic policy response. Health Policy Technol. 2020;9:419–429. doi: 10.1016/j.hlpt.2020.08.021. - DOI - PMC - PubMed
    1. Fitzpatrick O., Ni Dhonaill R., Linehan A., Coyne Z., Hennessy M., Clarke M., McGee E., Barrett F., O’Doherty D., Matassa C., et al. Delivery of systemic anticancer therapy during the COVID-19 pandemic. Ir. J. Med. Sci. 2021;191:559–562. doi: 10.1007/s11845-021-02631-1. - DOI - PMC - PubMed

LinkOut - more resources