1. Evaluating Demographic Representation in Clinical Trials: Use of the Adaptive Coronavirus Disease 2019 Treatment Trial (ACTT) as a Test Case.
- Author
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Ortega-Villa, Ana M, Hynes, Noreen A, Levine, Corri B, Yang, Katherine, Wiley, Zanthia, Jilg, Nikolaus, Wang, Jing, Whitaker, Jennifer A, Colombo, Christopher J, Nayak, Seema U, Kim, Hannah Jang, Iovine, Nicole M, Ince, Dilek, Cohen, Stuart H, Langer, Adam J, Wortham, Jonathan M, Atmar, Robert L, El Sahly, Hana M, Jain, Mamta K, Mehta, Aneesh K, Wolfe, Cameron R, Gomez, Carlos A, Beresnev, Tatiana, Mularski, Richard A, Paules, Catharine I, Kalil, Andre C, Branche, Angela R, Luetkemeyer, Annie, Zingman, Barry S, Voell, Jocelyn, Whitaker, Michael, Harkins, Michelle S, Davey, Richard T, Grossberg, Robert, George, Sarah L, Tapson, Victor, Short, William R, Ghazaryan, Varduhi, Benson, Constance A, Dodd, Lori E, Sweeney, Daniel A, and Tomashek, Kay M
- Subjects
ACTT ,COVID-19 clinical trials ,representation evaluation ,Clinical Research ,Infectious Diseases ,Prevention ,Clinical Trials and Supportive Activities ,Good Health and Well Being - Abstract
BackgroundClinical trials initiated during emerging infectious disease outbreaks must quickly enroll participants to identify treatments to reduce morbidity and mortality. This may be at odds with enrolling a representative study population, especially when the population affected is undefined.MethodsWe evaluated the utility of the Centers for Disease Control and Prevention's COVID-19-Associated Hospitalization Surveillance Network (COVID-NET), the COVID-19 Case Surveillance System (CCSS), and 2020 United States (US) Census data to determine demographic representation in the 4 stages of the Adaptive COVID-19 Treatment Trial (ACTT). We compared the cumulative proportion of participants by sex, race, ethnicity, and age enrolled at US ACTT sites, with respective 95% confidence intervals, to the reference data in forest plots.ResultsUS ACTT sites enrolled 3509 adults hospitalized with COVID-19. When compared with COVID-NET, ACTT enrolled a similar or higher proportion of Hispanic/Latino and White participants depending on the stage, and a similar proportion of African American participants in all stages. In contrast, ACTT enrolled a higher proportion of these groups when compared with US Census and CCSS. The proportion of participants aged ≥65 years was either similar or lower than COVID-NET and higher than CCSS and the US Census. The proportion of females enrolled in ACTT was lower than the proportion of females in the reference datasets.ConclusionsAlthough surveillance data of hospitalized cases may not be available early in an outbreak, they are a better comparator than US Census data and surveillance of all cases, which may not reflect the population affected and at higher risk of severe disease.
- Published
- 2023