Dataset Information

Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials.

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.

SUBMITTER: Flores LE

PROVIDER: S-EPMC7896193 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials.

Flores Laura E LE Frontera Walter R WR Andrasik Michele P MP Del Rio Carlos C Mondríguez-González Antonio A Price Stephanie A SA Krantz Elizabeth M EM Pergam Steven A SA Silver Julie K JK

JAMA network open 20210201 2

<h4>Importance</h4>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.<h4>Objective</h4>To investigate whether racial/ethnic minority groups and female and older adults are underrepresented among participants in vaccine clinical trials.<h4>Design, s ...[more]

PMID: 33606033

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Project description:ImportanceThe COVID-19 pandemic has had disproportionate effects on racial and ethnic minority communities, where preexisting clinical and social conditions amplify health and social disparities. Many of these communities report lower vaccine confidence and lower receipt of the COVID-19 vaccine. Understanding factors that influence the multifaceted decision-making process for vaccine uptake is critical for narrowing COVID-19-related disparities.ObjectiveTo examine factors that members of multiethnic communities at high risk for COVID-19 infection and morbidity report as contributing to vaccine decision-making.Design, setting, and participantsThis qualitative study used community-engaged methods to conduct virtual focus groups from November 16, 2020, to January 28, 2021, with Los Angeles County residents. Potential participants were recruited through email, video, and telephone outreach to community partner networks. Focus groups were stratified by self-identified race and ethnicity as well as age. Transcripts were analyzed using reflexive thematic analysis.Main outcomes and measuresThemes were categorized by contextual, individual, and vaccine-specific influences using the World Health Organization's Vaccine Hesitancy Matrix categories.ResultsA total of 13 focus groups were conducted with 70 participants (50 [71.4%] female) who self-identified as American Indian (n = 17 [24.3%]), Black/African American (n = 17 [24.3%]), Filipino/Filipina (n = 11 [15.7%]), Latino/Latina (n = 15 [21.4%]), or Pacific Islander (n = 10 [14.3%]). A total of 39 participants (55.7%) were residents from high-poverty zip codes, and 34 (48.6%) were essential workers. The resulting themes included policy implications for equitable vaccine distribution: contextual influences (unclear and unreliable information, concern for inequitable access or differential treatment, references to mistrust from unethical research studies, accessibility and accommodation barriers, eligibility uncertainty, and fears of politicization or pharmaceutical industry influence); social and group influences (inadequate exposure to trusted messengers or information, altruistic motivations, medical mistrust, and desire for autonomy); and vaccination-specific influences (need for vaccine evidence by subpopulation, misconceptions on vaccine development, allocation ambiguity, vaccination safety preferences, the importance of perceiving vaccine equity, burden of vaccine scheduling, cost uncertainty, and desire for practitioner recommendation).Conclusions and relevanceIn this qualitative study, participants reported a number of factors that affected their vaccine decision-making, including concern for inequitable vaccine access. Participants endorsed policy recommendations and strategies to promote vaccine confidence. These results suggest that support of informed deliberation and attainment of vaccine equity will require multifaceted, multilevel policy approaches that improve COVID-19 vaccine knowledge, enhance trust, and address the complex interplay of sociocultural and structural barriers to vaccination.

Project description:ImportancePatients from racial and ethnic minority groups (eg, Asian, Hispanic, and non-Hispanic Black patients) have low representation in clinical trials, especially in phase 1 trials in cancer. These trials represent valuable options for patients with advanced cancer who experience disease progression with standard therapy.ObjectiveTo determine whether the benefit of enrollment to phase 1 cancer trials extends to Asian, Hispanic, and non-Hispanic Black patients as much as it does for non-Hispanic White patients.Data sourcesPatient records at a single institution from January 1999 to December 2016 were reviewed. Treatment-related responses, toxic effects, and deaths were recorded.Study selectionAll phase 1 studies were included.Data extraction and synthesisData underwent independent extraction by multiple observers following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline.Main outcomes and measuresThe primary outcome was overall survival (OS), assessed using univariate and multivariable time-to-event analyses.ResultsA total of 738 patients (median [range], 60 [22-93] years; 467 [63.3] female) including 197 Hispanic patients (26.7%), 238 non-Hispanic Black patients (32.2%), and 282 non-Hispanic White patients (38.2%), were enrolled in 64 phase 1 trials, including 33 cytotoxic trials (51.5%), 21 biologic trials (32.8%), and 10 combined therapy trials (15.6%). The primary cancer diagnoses were colorectal (187 patients [25.3%]), ovarian (141 patients [19.1%]), lung (58 patients [7.9%]), uterine (49 patients [6.6%]), and breast (41 patients [5.6%]). Patients underwent a median (range) of 3 (0-13) therapies prior to trial enrollment. Among 558 patients evaluated for response, the clinical benefit rate (ie, stable disease plus response rates) was 49.1%, and the overall response rate was 6.5%. Grade 3 or 4 nonhematological toxic effects were observed in 27.8% (95% CI, 24.6%-31.3%) of patients and grade 3 or 4 hematological toxic effects were observed in 19.7% (95% CI, 17.0%-22.8%) of patients. The treatment-related mortality rate was 0.9% (95% CI, 0.4%-1.9%). Median OS was 9.6 (95% CI, 8.2-11.0) months among Hispanic patients, 8.3 (95% CI, 6.7-10.4) months among non-Hispanic Black patients, and 9.8 (95% CI, 8.5-11.4) months among non-Hispanic White patients (P = .13). In a multivariable analysis, age older than 60 years, Eastern Cooperative Oncology Group performance status score of 2 or greater, more than 2 metastatic sites, lactate dehydrogenase grade 1 or 2, grade 2 or greater low albumin, grade 1 or greater total bilirubin, and grade 2 or greater anemia were associated with worse prognosis, whereas leukocytosis greater than grade 1 was associated with better OS.Conclusions and relevanceIn this meta-analysis assessing outcomes in phase 1 cancer trials among patients from racial and ethnic minority groups, Hispanic and non-Hispanic Black patients had benefits similar to those of non-Hispanic White patients.

Project description:BackgroundType 2 diabetes is a serious, pervasive metabolic condition that disproportionately affects ethnic minority patients. Telehealth interventions can facilitate type 2 diabetes monitoring and prevent secondary complications. However, trials designed to test the effectiveness of telehealth interventions may underrecruit or exclude ethnic minority patients, with language a potential barrier to recruitment. The underrepresentation of minorities in trials limits the external validity of the findings for this key patient demographic.ObjectiveThis systematic review examines (1) the research reporting practices and prevalence of ethnic minority patients included in telehealth randomized controlled trials (RCTs) targeting type 2 diabetes and the trial characteristics associated with recruiting a high proportion of minority patients, and (2) the proportion of included RCTs that report using English language proficiency as a patient screening criterion and how and why they do so.MethodsTelehealth RCTs published in refereed journals targeting type 2 diabetes as a primary condition for adults in Western majority English-speaking countries were included. Ethnically targeted RCTs were excluded from the main review, but were included in a post hoc subgroup analysis. Abstract and full-text screening, risk of bias assessment, and data extraction were independently conducted by two reviewers.ResultsOf 3358 records identified in the search, 79 articles comprising 58 RCTs were included. Nearly two-thirds of the RCTs (38/58) reported on the ethnic composition of participants, with a median proportion of 23.5% patients (range 0%-97.7%). Fourteen studies (24%) that included at least 30% minority patients were all US-based, predominantly recruited from urban areas, and described the target population as underserved, financially deprived, or uninsured. Eight of these 14 studies (57%) offered intervention materials in a language other than English or employed bilingual staff. Half of all identified RCTs (29/58) included language proficiency as a participant-screening criterion. Language proficiency was operationalized using nonstandardized measures (eg, having sufficient "verbal fluency"), with only three studies providing reasons for excluding patients on language grounds.ConclusionsThere was considerable variability across studies in the inclusion of ethnic minority patients in RCTs, with higher participation rates in countries with legislation to mandate their inclusion (eg, United States) than in those without such legislation (eg, United Kingdom). Less than 25% of the RCTs recruited a sizeable proportion of ethnic minorities, which raises concerns about external validity. The lack of objective measures or common procedures for assessing language proficiency across trials implies that language-related eligibility decisions are often based on trial recruiters' impressionistic judgments, which could be subject to bias. The variability and inconsistent reporting on ethnicity and other socioeconomic factors in descriptions of research participants could be more specifically emphasized in trial reporting guidelines to promote best practice.Trial registrationPROSPERO International Prospective Register of Systematic Reviews: CRD42015024899; http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42015024899 (Archived by WebCite at http://www.webcitation.org/6kQmI2bdF).

Dataset Information

Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials.

Importance

Objective

Design, setting, and participants

Main outcomes and measures

Results

Conclusions and relevance

Publications

Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials.

Similar Datasets

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