tetano
Editor, Senior Moderator
Open Forum Infect Dis
. 2023 May 27;10(6)
fad290.
doi: 10.1093/ofid/ofad290. eCollection 2023 Jun. Evaluating Demographic Representation in Clinical Trials: Use of the Adaptive Coronavirus Disease 2019 Treatment Trial (ACTT) as a Test Case
Ana M Ortega-Villa[SUP] 1 [/SUP], Noreen A Hynes[SUP] 2 [/SUP], Corri B Levine[SUP] 3 [/SUP], Katherine Yang[SUP] 4 [/SUP], Zanthia Wiley[SUP] 5 [/SUP], Nikolaus Jilg[SUP] 6 7 [/SUP], Jing Wang[SUP] 8 [/SUP], Jennifer A Whitaker[SUP] 9 [/SUP], Christopher J Colombo[SUP] 10 11 [/SUP], Seema U Nayak[SUP] 12 [/SUP], Hannah Jang Kim[SUP] 13 14 [/SUP], Nicole M Iovine[SUP] 15 [/SUP], Dilek Ince[SUP] 16 [/SUP], Stuart H Cohen[SUP] 17 [/SUP], Adam J Langer[SUP] 18 [/SUP], Jonathan M Wortham[SUP] 19 [/SUP], Robert L Atmar[SUP] 20 [/SUP], Hana M El Sahly[SUP] 9 [/SUP], Mamta K Jain[SUP] 21 [/SUP], Aneesh K Mehta[SUP] 22 23 [/SUP], Cameron R Wolfe[SUP] 24 [/SUP], Carlos A Gomez[SUP] 25 [/SUP], Tatiana Beresnev[SUP] 12 [/SUP], Richard A Mularski[SUP] 26 27 [/SUP], Catharine I Paules[SUP] 28 [/SUP], Andre C Kalil[SUP] 25 [/SUP], Angela R Branche[SUP] 29 [/SUP], Annie Luetkemeyer[SUP] 30 [/SUP], Barry S Zingman[SUP] 31 [/SUP], Jocelyn Voell[SUP] 32 [/SUP], Michael Whitaker[SUP] 19 [/SUP], Michelle S Harkins[SUP] 33 [/SUP], Richard T Davey Jr[SUP] 32 [/SUP], Robert Grossberg[SUP] 34 [/SUP], Sarah L George[SUP] 35 [/SUP], Victor Tapson[SUP] 36 [/SUP], William R Short[SUP] 37 [/SUP], Varduhi Ghazaryan[SUP] 12 [/SUP], Constance A Benson[SUP] 38 [/SUP], Lori E Dodd[SUP] 1 [/SUP], Daniel A Sweeney[SUP] 39 [/SUP], Kay M Tomashek[SUP] 12 [/SUP]
Affiliations
Background: 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.
Methods: 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.
Results: 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.
Conclusions: 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.
Keywords: ACTT; COVID-19 clinical trials; representation evaluation.
. 2023 May 27;10(6)
fad290.doi: 10.1093/ofid/ofad290. eCollection 2023 Jun. Evaluating Demographic Representation in Clinical Trials: Use of the Adaptive Coronavirus Disease 2019 Treatment Trial (ACTT) as a Test Case
Ana M Ortega-Villa[SUP] 1 [/SUP], Noreen A Hynes[SUP] 2 [/SUP], Corri B Levine[SUP] 3 [/SUP], Katherine Yang[SUP] 4 [/SUP], Zanthia Wiley[SUP] 5 [/SUP], Nikolaus Jilg[SUP] 6 7 [/SUP], Jing Wang[SUP] 8 [/SUP], Jennifer A Whitaker[SUP] 9 [/SUP], Christopher J Colombo[SUP] 10 11 [/SUP], Seema U Nayak[SUP] 12 [/SUP], Hannah Jang Kim[SUP] 13 14 [/SUP], Nicole M Iovine[SUP] 15 [/SUP], Dilek Ince[SUP] 16 [/SUP], Stuart H Cohen[SUP] 17 [/SUP], Adam J Langer[SUP] 18 [/SUP], Jonathan M Wortham[SUP] 19 [/SUP], Robert L Atmar[SUP] 20 [/SUP], Hana M El Sahly[SUP] 9 [/SUP], Mamta K Jain[SUP] 21 [/SUP], Aneesh K Mehta[SUP] 22 23 [/SUP], Cameron R Wolfe[SUP] 24 [/SUP], Carlos A Gomez[SUP] 25 [/SUP], Tatiana Beresnev[SUP] 12 [/SUP], Richard A Mularski[SUP] 26 27 [/SUP], Catharine I Paules[SUP] 28 [/SUP], Andre C Kalil[SUP] 25 [/SUP], Angela R Branche[SUP] 29 [/SUP], Annie Luetkemeyer[SUP] 30 [/SUP], Barry S Zingman[SUP] 31 [/SUP], Jocelyn Voell[SUP] 32 [/SUP], Michael Whitaker[SUP] 19 [/SUP], Michelle S Harkins[SUP] 33 [/SUP], Richard T Davey Jr[SUP] 32 [/SUP], Robert Grossberg[SUP] 34 [/SUP], Sarah L George[SUP] 35 [/SUP], Victor Tapson[SUP] 36 [/SUP], William R Short[SUP] 37 [/SUP], Varduhi Ghazaryan[SUP] 12 [/SUP], Constance A Benson[SUP] 38 [/SUP], Lori E Dodd[SUP] 1 [/SUP], Daniel A Sweeney[SUP] 39 [/SUP], Kay M Tomashek[SUP] 12 [/SUP]
Affiliations
- PMID: 37383244
- PMCID: PMC10296069
- DOI: 10.1093/ofid/ofad290
Background: 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.
Methods: 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.
Results: 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.
Conclusions: 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.
Keywords: ACTT; COVID-19 clinical trials; representation evaluation.