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
. 2024;14(5):570.
Epub 2024 Jul 25.

Impact of the COVID-19 Pandemic on Cancer Clinical Trials: Alliance for Clinical Trials in Oncology Experience (Alliance A152022)

Rebecca A Snyder  1   2 , Shauna L Hillman  3 , Veronique Marcotte  3 , Electra D Paskett  4 , Suzanne George  5 , Olwen Hahn  6 , Sumithra J Mandrekar  3
Affiliations

Impact of the COVID-19 Pandemic on Cancer Clinical Trials: Alliance for Clinical Trials in Oncology Experience (Alliance A152022)

Rebecca A Snyder et al. J Clin Trials. 2024.

Abstract

Objective: The COVID-19 pandemic led to immediate changes in cancer clinical trial conduct. The primary aims of this study were to summarize the impact of the pandemic on Alliance for Clinical Trials in Oncology (Alliance) enrollment, protocol deviations, COVID-19 events (positive or presumptive-positive COVID test), and premature study discontinuation rates.

Methods: Enrollment trends were examined from January 2019 (pre COVID-19 pandemic) through 2022. Data were captured for protocol deviations and premature treatment and study discontinuation events across all Alliance protocols using a centralized Medidata Rave database, and summarized from January 1, 2020, through June 30, 2022. Descriptive statistics and graphical techniques are used to summarize observed trends.

Results: Overall enrollment across Alliance trials decreased during the COVID-19 pandemic and remained below pre-pandemic levels in 2022. Racial and ethnic demographics of enrolled patients did not change substantially. 4805 protocol deviations were reported on 2745 unique patients, with at least one protocol deviation reported by 618 sites and 77 unique trials. Commonly reported deviations were telemedicine visits (n=2167, 45%) and late/missed study procedures (n=2150, 45%). A total of 826 COVID-19 events were reported in 659 unique patients. Of an estimated 18,000 enrolled patients, only 68 withdrew from treatment and 45 withdrew from study due to COVID-19.

Conclusion: A centralized COVID-19 database enabled a comprehensive assessment of the impact of the pandemic across Alliance trials. COVID-19 led to an immediate decline in enrollment across all patient populations. While the number of trials open to patient accrual remained stable, several large, adjuvant studies completed accrual during this period, which contributed to accrual decline. Telemedicine usage was notable, and both COVID-19 events and study discontinuation due to COVID-19 were rare.

Keywords: Accrual trends; COVID-19; Clinical trials; National Clinical Trials Network (NCTN); National Community Oncology Research Program (NCORP); Pandemic; Protocol deviations; Telemedicine.

PubMed Disclaimer

Figures

Figure 1:
Figure 1:
CONSORT diagram for COVID deviations1. Note: 1: COVID deviations that were categorized as “Other” were manually reviewed to identify the ones that should have been reported as a late procedure or as a virtual visit, or both. If multiple deviations of the same type were reported on the same day for the same patient, the duplicates were removed and only one of them was kept.
Figure 2:
Figure 2:
Alliance clinical trial enrollment (January 1, 2019-December 31, 2022). Note: formula image 2019 (N=5760 Participants); formula image 2020 (N=5327 Participants); formula image 2021 (N=4951 Participants); formula image 2022 (N=3073 Participants)
Figure 3:
Figure 3:
Accrual to alliance trials from January 1, 2019-December 31, 2022. Note: A) By race/Ethnicity; B) By gender; C) By area deprivation index; D) By metropolitan status.
Figure 4:
Figure 4:
Distribution of accrual by age in years (median and interquartile range).
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. World Health Organization. Report of the WHO-China joint mission on coronavirus disease 2019 (COVID-19). 2020;1–40.
    1. Liang W, Guan W, Chen R, Wang W, Li J, Xu K, et al. Cancer patients in SARS-CoV-2 infection: A nationwide analysis in China. Lancet Oncol 2020;21(3):335–337. - PMC - PubMed
    1. Boughey JC, Snyder RA, Kantor O, Zheng L, Chawla A, Nguyen TT, et al. Impact of the COVID-19 pandemic on cancer clinical trials. Ann Surg Oncol 2021;28:7311–7316. - PMC - PubMed
    1. Schrag D, Hershman DL, Basch E. Oncology practice during the COVID-19 pandemic. JAMA 2020;323(20):2005–2006. - PubMed
    1. Waterhouse DM, Harvey RD, Hurley P, Levit LA, Kim ES, Klepin HD, et al. Early impact of COVID-19 on the conduct of oncology clinical trials and long-term opportunities for transformation: findings from an American Society of Clinical Oncology Survey. JCO Oncol Pract 2020;16(7):417–421. - PubMed

LinkOut - more resources