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Evaluating Demographic Representation in Clinical Trials: Use of the Adaptive Coronavirus Disease 2019 Treatment Trial (ACTT) as a Test Case

  1. Author:
    Ortega-Villa, Ana M [ORCID]
    Hynes, Noreen A
    Levine, Corri B
    Yang, Katherine [ORCID]
    Wiley, Zanthia
    Jilg, Nikolaus [ORCID]
    Wang,Jing
    Whitaker, Jennifer A
    Colombo, Christopher J
    Nayak, Seema U
    Kim, Hannah Jang
    Iovine, Nicole M
    Ince, Dilek [ORCID]
    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 [ORCID]
    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
    Tomashek, Kay M

  2. Author Address

    Biostatistics Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, Rockville, Maryland, USA., Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Division of Infectious Disease, Department of Internal Medicine, University of Texas Medical Branch, Galveston, Texas, USA., Department of Clinical Pharmacy, University of California, San Francisco, San Francisco, California, USA., Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA., Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA., Brigham and Women 39;s Hospital, Harvard Medical School, Boston, Massachusetts, USA., Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA., Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA., Department of Virtual Health and Department of Medicine, Madigan Army Medical Center, Tacoma, Washington, USA., Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA., Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA., Department of Community Health Systems, School of Nursing, University of California, San Francisco, San Francisco, California, USA., National Patient Care Services, Kaiser Permanente, Oakland, California, USA., Division of Infectious Diseases and Global Medicine, Department of Medicine, University of Florida Health, Gainesville, Florida, USA., Division of Infectious Diseases, Department of Internal Medicine, University of Iowa, Iowa City, Iowa, USA., Division of Infectious Diseases, University of California, Davis, Sacramento, California, USA., COVID-19 Emergency Response Team, Centers for Disease Control and Prevention, Atlanta, Georgia, USA., COVID-19-Associated Hospitalization Surveillance Network, Centers for Disease Control and Prevention, Atlanta, Georgia, USA., Department of Medicine, Baylor College of Medicine, Houston, Texas, USA., Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA., Division of Infection Diseases, Emory University School of Medicine, Atlanta, Georgia, USA., National Emerging Special Pathogens Treatment and Education Center, Atlanta, Georgia, USA., Division of Infectious Diseases, Department of Medicine, Duke University Medical Center, Durham, North Carolina, USA., Division of Infectious Diseases, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska, USA., Department of Pulmonary and Critical Care Medicine, Northwest Permanente, Kaiser Permanente Northwest, Portland, Oregon, USA., The Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, USA., Division of Infectious Diseases, Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA., Division of Infectious Diseases, Department of Medicine, University of Rochester Medical Center, Rochester, New York, USA., Department of Medicine, University of California, San Francisco, San Francisco, California, USA., Department of Medicine, Montefiore Medical Center, University Hospital for Albert Einstein College of Medicine, Bronx, New York, USA., Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA., Division of Pulmonary and Critical Care, Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA., Division of Infectious Diseases, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York, USA., Department of Internal Medicine, Saint Louis University and St Louis Veterans Affairs Medical Center, St Louis, Missouri, USA., Division of Pulmonary and Critical Care, Cedars-Sinai Medical Center, Los Angeles, California, USA., Division of Infectious Diseases, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA., Division of Infectious Diseases and Global Public Health, University of California, San Diego, San Diego, California, USA., Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, University of California, San Diego, San Diego, California, USA.,
    1. Year: 2023
    2. Date: Jun
    3. Epub Date: 2023 05 27
  2. Journal: Open Forum Infectious Diseases
    1. 10
    2. 6
    3. Pages: ofad290
  4. Type of Article: Article
  5. Article Number: ofad290
  1. Abstract:

    Clinical 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. We 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. US 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. Although 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 by Oxford University Press on behalf of Infectious Diseases Society of America 2023.

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External Sources

  1. View Full Text
  2. DOI: 10.1093/ofid/ofad290
  3. PMID: 37383244
  4. PMCID: PMC10296069
  5. PII : ofad290

Library Notes

  1. Fiscal Year: FY2022-2023
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