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. 2023 Jul 3;7(4):pkad048.
doi: 10.1093/jncics/pkad048.

Quantifying the impact of the COVID-19 pandemic on cancer center clinical trial operations

Thomas J George  1 , Tara L Lin  2 , Tricia Adrales Bentz  3 , Stefan Grant  4 , Collette M Houston  5 , Melissa A Nashawati  6 , Bhanu Pappu  7 , Helen Peck  8 , Alex Zafirovski  9 , Kimberly Kerstann  10 , Patricia LoRusso  11 , Anne Schnatterly  12 , Janie Hofacker  13 , Kendra Cameron  13 , Hailey Honeycutt  13 , Theresa L Werner  14
Affiliations

Quantifying the impact of the COVID-19 pandemic on cancer center clinical trial operations

Thomas J George et al. JNCI Cancer Spectr. .

Abstract

Background: Oncology clinical trials are complex, and the COVID-19 pandemic caused major disruptions in 2020.

Methods: Using its networking and sharing of best practices, the Association of American Cancer Institutes, comprising 105 cancer centers, solicited a longitudinal series of voluntary surveys from members to assess how clinical trial office operations were affected. The surveys showed that centers were able to keep oncology trials available to patients while maintaining safety. Data were collected regarding interventional clinical trial accruals for the calendar years 2019, 2020, and 2021.

Results: Data demonstrated a sizeable decrease in interventional treatment trial accruals in both 2020 and 2021 compared with prepandemic figures in 2019. No cancer center reported an increase in interventional treatment trial accruals in 2020 compared with 2019, with most centers reporting a moderate decrease. In mid-2022, 15% of respondents reported an increasing trend, 31% reported no significant change, and 54% continued to report a decrease.

Conclusions: The pandemic necessitated rapid adoption of trial operations, with the emergence of several best practices, including remote monitoring, remote consenting, electronic research charts, and work-from-home strategies for staff. The national infrastructure to conduct trials was significantly affected by the pandemic, with noteworthy resiliency, evidenced by improvements in efficiencies and patient-centered care delivery but with residual capacity challenges that will be evident for the foreseeable future.

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Conflict of interest statement

Dr George has disclosed consulting or holding an advisory role for Tempus and Pfizer. Dr Stefan Grant disclosed holding equity for TheraBionic, Inc; is an advisory board member for Florence Healthcare; and receives research support from Guardant Health. Dr Patricia LoRusso disclosed being on the following advisory boards for the following: AbbVie; Agios; GenMab; Roche-Genentech; CytomX; Takeda; Cybrexa; Agenus; IQVIA; TRIGR; Pfizer; ImmunoMet; Black Diamond; GlaxoSmithKline; QED Therapeutics; AstraZeneca; EMD Serono; Shattuck; Astellas; Salarius Silverback; MacroGenics; Kyowa Kirin Pharmaceutical Development; Kineta, Inc.; Zentalis Pharmaceuticals; Molecular Templates; ABL Bio; SK Life Science; STCube Pharmaceuticals; Bayer; I-Mab; Seagen; imCheck; Relay Therapeutics; Stemline; Compass BADX; Mekanist; Mersana Therapeutics; BAKX Therapeutics; Scenic Biotech; Qualigen; Roivant Sciences; and NeuroTrials. The remaining authors have disclosed that they have not received any financial consideration from any person or organization to support the preparation, analysis, results, or discussion of this article.

Figures

Figure 1.
Figure 1.
Distribution and locations of participating centers.
Figure 2.
Figure 2.
Survey evolution and participation among respondents. AACI = Association of American Cancer Institutions.
Figure 3.
Figure 3.
A) Interventional treatment trial accruals (national aggregate) per year, by survey participants. B) Interventional nontreatment trial accruals (national aggregate) per year, by survey participants.
Figure 4.
Figure 4.
A) New methods adopted to facilitate remote monitoring as a result of the COVID-19 pandemic. B) Trial monitoring options that centers offered in the early phase of the pandemic (2020). C) Trial monitoring options that cancer centers offered moving forward (2022). EMR = electronic medical record.
Figure 5.
Figure 5.
A) Clinical research office departments affected by departures. B) Reasons for clinical research staff departures. C) Greatest ongoing challenge to clinical research operations at cancer centers (2022). QA = quality assurance; RN = registered nurse.
See this image and copyright information in PMC

References

    1. Yabroff KR, Wu XC, Negoita S, et al. Association of the COVID-19 pandemic with patterns of statewide cancer services. J Natl Cancer Inst. 2022;114(6):907-909. doi: 10.1093/jnci/djab122. - DOI - PMC - PubMed
    1. Broom A, Kenny K, Page A, et al. The paradoxical effects of COVID-19 on cancer care: current context and potential lasting impacts. Clin Cancer Res. 2020;26(22):5809-5813. doi: 10.1158/1078-0432.CCR-20-2989. - DOI - PubMed
    1. Tolaney SM, Lydon CA, Li T, et al. The impact of COVID-19 on clinical trial execution at the Dana-Farber Cancer Institute. J Natl Cancer Inst. 2021;113(11):1453-1459. doi: 10.1093/jnci/djaa144. - DOI - PMC - PubMed
    1. Upadhaya S, Yu JX, Oliva C, Hooton M, Hodge J, Hubbard-Lucey VM.. Impact of COVID-19 on oncology clinical trials. Nat Rev Drug Discov. 2020;19(6):376-377. doi: 10.1038/d41573-020-00093-1. - DOI - PubMed
    1. Boughey JC, Snyder RA, Kantor O, et al. Impact of the COVID-19 pandemic on cancer clinical trials. Ann Surg Oncol. 2021;28(12):7311-7316. doi: 10.1245/s10434-021-10406-2. - DOI - PMC - PubMed

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