TY - JOUR
T1 - Sponsor Perspectives on the Impact of the COVID-19 Pandemic on Interventional Cancer Clinical Trial Protocols and Data Quality
AU - Unger, Joseph M.
AU - Stires, Hillary
AU - Levit, Laura A.
AU - Stewart, Mark
AU - McKelvey, Brittany Avin
AU - Canin, Beverly
AU - Dressler, Emily
AU - Flaherty, Keith
AU - Fredette, Peter
AU - Jones, Lee
AU - McCann, Peggy
AU - Miller, Therica
AU - Onitilo, Adedayo A.
AU - Palmieri, Fran
AU - Patel, Timil
AU - Paul, Rocio
AU - Smith, Gary L.
AU - Bruinooge, Suanna S.
AU - Garrett-Mayer, Elizabeth
AU - Lei, Xiudong Jennifer
AU - Alva, Ajjai
AU - Schenkel, Caroline
N1 - Publisher Copyright:
© 2023 by American Society of Clinical Oncology.
PY - 2023/10/1
Y1 - 2023/10/1
N2 - PURPOSE The onset of the COVID-19 pandemic created major disruptions in the conduct of cancer clinical trials. In response, regulators and sponsors allowed modifications to traditional trial processes to enable clinical research and care to continue. We systematically evaluated how these mitigation strategies affected data quality and overall trial conduct. METHODS This study used surveys and live interviews. Forty-one major industry and National Cancer Institute Network groups (sponsors) overseeing anticancer treatment trials open in the United States from January 2015 to May 2022 were invited to participate. Descriptive statistics were used for survey data summaries. Key themes from interviews were identified. RESULTS Twenty sponsors (48.8%; 15 industry and five Network groups) completed the survey; 11/20 (55.0%) participated in interviews. Sponsors predominantly (n 5 12; 60.0%) reported large (≥11 trials) portfolios of phase II and/or phase III trials. The proportion of sponsors reporting a moderate (9) or substantial (8) increase in protocol deviations in the initial pandemic wave versus the pre-pandemic period was 89.5% (17/19); the proportion reporting a substantial increased dropped from 42.1% (n 5 8/19) in the initial wave to 15.8% (n 5 3/19) thereafter. The most commonly adopted mitigation strategies were remote distribution of oral anticancer therapies (70.0%), remote adverse event monitoring (65.0%), and remote consenting (65.0%). Most respondents (15/18; 83.3%) reported that the pandemic had minimal (n 5 14) or no impact (n 5 1) on overall data integrity. CONCLUSION Despite nearly all sponsors observing a temporary increase in protocol deviations, most reported the pandemic had minimal/no impact on overall data integrity. The COVID-19 pandemic accelerated an emerging trend toward greater flexibility in trial conduct, with potential benefits of reduced burden on trial participants and sites and improved patient access to research.
AB - PURPOSE The onset of the COVID-19 pandemic created major disruptions in the conduct of cancer clinical trials. In response, regulators and sponsors allowed modifications to traditional trial processes to enable clinical research and care to continue. We systematically evaluated how these mitigation strategies affected data quality and overall trial conduct. METHODS This study used surveys and live interviews. Forty-one major industry and National Cancer Institute Network groups (sponsors) overseeing anticancer treatment trials open in the United States from January 2015 to May 2022 were invited to participate. Descriptive statistics were used for survey data summaries. Key themes from interviews were identified. RESULTS Twenty sponsors (48.8%; 15 industry and five Network groups) completed the survey; 11/20 (55.0%) participated in interviews. Sponsors predominantly (n 5 12; 60.0%) reported large (≥11 trials) portfolios of phase II and/or phase III trials. The proportion of sponsors reporting a moderate (9) or substantial (8) increase in protocol deviations in the initial pandemic wave versus the pre-pandemic period was 89.5% (17/19); the proportion reporting a substantial increased dropped from 42.1% (n 5 8/19) in the initial wave to 15.8% (n 5 3/19) thereafter. The most commonly adopted mitigation strategies were remote distribution of oral anticancer therapies (70.0%), remote adverse event monitoring (65.0%), and remote consenting (65.0%). Most respondents (15/18; 83.3%) reported that the pandemic had minimal (n 5 14) or no impact (n 5 1) on overall data integrity. CONCLUSION Despite nearly all sponsors observing a temporary increase in protocol deviations, most reported the pandemic had minimal/no impact on overall data integrity. The COVID-19 pandemic accelerated an emerging trend toward greater flexibility in trial conduct, with potential benefits of reduced burden on trial participants and sites and improved patient access to research.
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U2 - 10.1200/OP.23.00185
DO - 10.1200/OP.23.00185
M3 - Article
C2 - 37643386
AN - SCOPUS:85173604011
SN - 2688-1527
VL - 19
SP - 907
EP - 916
JO - JCO Oncology Practice
JF - JCO Oncology Practice
IS - 10
ER -