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Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials.
Flores, Laura E; Frontera, Walter R; Andrasik, Michele P; Del Rio, Carlos; Mondríguez-González, Antonio; Price, Stephanie A; Krantz, Elizabeth M; Pergam, Steven A; Silver, Julie K.
  • Flores LE; College of Allied Health Professions, University of Nebraska Medical Center, Omaha.
  • Frontera WR; Department of Physical Medicine, Rehabilitation and Sports Medicine and Department of Physiology, University of Puerto Rico School of Medicine, San Juan.
  • Andrasik MP; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
  • Del Rio C; Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.
  • Mondríguez-González A; Hubert Department of Global Health, Rollin School of Public Health of Emory University, Atlanta, Georgia.
  • Price SA; Universidad Central del Caribe, Bayamón, Puerto Rico.
  • Krantz EM; Hellen Keller International, New York, New York.
  • Pergam SA; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
  • Silver JK; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
JAMA Netw Open ; 4(2): e2037640, 2021 02 01.
Article in English | MEDLINE | ID: covidwho-1092150
ABSTRACT
Importance Medical research has not equitably included members of racial/ethnic minority groups or female and older individuals. There are limited data on participant demographic characteristics in vaccine trials despite the importance of these data to current trials aimed at preventing coronavirus disease 2019.

Objective:

To investigate whether racial/ethnic minority groups and female and older adults are underrepresented among participants in vaccine clinical trials. Design, Setting, and

Participants:

This cross-sectional study examined data from completed US-based vaccine trials registered on ClinicalTrials.gov from July 1, 2011, through June 30, 2020. The terms vaccine, vaccination, immunization, and inoculation were used to identify trials. Only those addressing vaccine immunogenicity or efficacy of preventative vaccines were included. Main Outcomes and

Measures:

The numbers and percentages of racial/ethnic minority, female, and older individuals compared with US census data from 2011 and 2018. Secondary outcome measures were inclusion by trial phase and year of completion.

Results:

A total of 230 US-based trials with 219 555 participants were included in the study. Most trials were randomized (180 [78.3%]), included viral vaccinations (159 [69.1%]), and represented all trial phases. Every trial reported age and sex; 134 (58.3%) reported race and 79 (34.3%) reported ethnicity. Overall, among adult study participants, White individuals were overrepresented (77.9%; 95% CI, 77.4%-78.4%), and Black or African American individuals (10.6%; 95% CI, 10.2%-11.0%) and American Indian or Alaska Native individuals (0.4%; 95% CI, 0.3%-0.5%) were underrepresented compared with US census data; enrollment of Asian individuals was similar (5.7%; 95% CI, 5.5%-6.0%). Enrollment of Hispanic or Latino individuals (11.6%; 95% CI, 11.1%-12.0%) was also low even among the limited number of adult trials reporting ethnicity. Adult trials were composed of more female participants (75 325 [56.0%]), but among those reporting age as a percentage, enrollment of participants who were aged 65 years or older was low (12.1%; 95% CI, 12.0%-12.3%). Black or African American participants (10.1%; 95% CI, 9.7%-10.6%) and Hispanic or Latino participants (22.5%; 95% CI, 21.6%-23.4%) were also underrepresented in pediatric trials. Among trials reporting race/ethnicity, 65 (48.5%) did not include American Indian or Alaska Native participants and 81 (60.4%) did not include Hawaiian or Pacific Islander participants. Conclusions and Relevance This cross-sectional study found that among US-based vaccine clinical trials, members of racial/ethnic minority groups and older adults were underrepresented, whereas female adults were overrepresented. These findings suggest that diversity enrollment targets should be included for all vaccine trials targeting epidemiologically important infections.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Vaccines / Ethnicity / Clinical Trials as Topic / Patient Selection / Sexism Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Journal: JAMA Netw Open Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Vaccines / Ethnicity / Clinical Trials as Topic / Patient Selection / Sexism Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Journal: JAMA Netw Open Year: 2021 Document Type: Article