Participation of Patients From Racial and Ethnic Minority Groups in Phase 1 Early Cancer Drug Development Trials in the US, 2000-2018.
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ABSTRACT:
SUBMITTER: Dunlop H
PROVIDER: S-EPMC9634497 | biostudies-literature | 2022 Nov
REPOSITORIES: biostudies-literature
Publications
Participation of Patients From Racial and Ethnic Minority Groups in Phase 1 Early Cancer Drug Development Trials in the US, 2000-2018.
Dunlop Hayley H Fitzpatrick Evelyn E Kurti Kevin K Deeb Stephanie S Gillespie Erin F EF Dover Laura L Yerramilli Divya D Gomez Scarlett Lin SL Chino Fumiko F Tsai C Jillian CJ
JAMA network open 20221101 11
<h4>Importance</h4>Despite federal initiatives encouraging the enrollment of individuals from racial and ethnic minority groups in US clinical trials, no studies to date have specifically examined demographic disparities among participants in phase 1 drug development trials for patients with metastatic cancer.<h4>Objective</h4>To assess trends in the enrollment of patients from racial and ethnic minority groups in US phase 1 therapeutic drug trials for metastatic cancer from 2000 to 2018.<h4>Des ...[more]
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Project description:ObjectiveTo examine the effectiveness of current community-based participatory research (CBPR) clinical trials involving racial and ethnic minorities.Data sourceAll published peer-reviewed CBPR intervention articles in PubMed and CINAHL databases from January 2003 to May 2010.Study designWe performed a systematic literature review.Data collection/extraction methodsData were extracted on each study's characteristics, community involvement in research, subject recruitment and retention, and intervention effects.Principle findingsWe found 19 articles meeting inclusion criteria. Of these, 14 were published from 2007 to 2010. Articles described some measures of community participation in research with great variability. Although CBPR trials examined a wide range of behavioral and clinical outcomes, such trials had very high success rates in recruiting and retaining minority participants and achieving significant intervention effects.ConclusionsSignificant publication gaps remain between CBPR and other interventional research methods. CBPR may be effective in increasing participation of racial and ethnic minority subjects in research and may be a powerful tool in testing the generalizability of effective interventions among these populations. CBPR holds promise as an approach that may contribute greatly to the study of health care delivery to disadvantaged populations.
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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.
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Project description:BackgroundCertain racial/ethnic minority groups have a higher risk of developing dementia, yet studies have demonstrated that they often have limited knowledge and understanding of this disease. An increasing number of educational and advocacy programs have been developed to promote dementia knowledge. We aimed at assessing current evidence and quality regarding educational interventions for promoting dementia knowledge.MethodsWe searched for intervention studies published in English that focused on educational interventions for promoting dementia knowledge among racial/ethnic minority groups. We identified 25 relevant studies through PubMed, PsycINFO, CINAHL, and Scopus, using tailored search terms. We screened titles and abstracts, reviewed full texts, synthesized relevant evidence, and evaluated the studies' quality based on the Mixed Methods Appraisal Tool. Relevant intervention studies took place in communities, hospitals or clinics, and schools, and online.ResultsMost studies were conducted in the United States (n = 21), followed by the UK (n = 3). Over half of the studies included Asian/Pacific Islander groups (n = 14), followed by Black groups (n = 12) and Hispanic groups (n = 11). The intervention delivery mode varied across studies-from workshops hosted in a faith community to talk shows on YouTube. Target populations included middle-aged and older adults, caregivers and family members, health students and professionals, and elementary school students. Common content included symptoms and signs of dementia, protective and risk factors, and local resources. The assessment of study outcomes varied across studies. Improvement in dementia knowledge and attitudes towards dementia was reported in many studies. Among the included studies, intervention satisfaction was high. The overall quality of the interventions was low.ConclusionFormally evaluated educational interventions promoting dementia knowledge are at an early stage. Existing published interventions showed adequate acceptability and promise in promoting better understanding and awareness of dementia in minority groups. More well-designed randomized controlled trials are needed.
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Project description:BackgroundThe use of mental health apps (MHAs) is increasing rapidly. However, little is known about the use of MHAs by racial and ethnic minority groups.ObjectiveIn this review, we aimed to examine the acceptability and effectiveness of MHAs among racial and ethnic minority groups, describe the purposes of using MHAs, identify the barriers to MHA use in racial and ethnic minority groups, and identify the gaps in the literature.MethodsA systematic search was conducted on August 25, 2023, using Web of Science, Embase, PsycINFO, PsycArticles, PsycExtra, and MEDLINE. Articles were quality appraised using the Mixed Methods Appraisal Tool, and data were extracted and summarized to form a narrative synthesis.ResultsA total of 15 studies met the inclusion criteria. Studies were primarily conducted in the United States, and the MHAs designed for racial and ethnic minority groups included ¡Aptívate!, iBobbly, AIMhi- Y, BRAVE, Build Your Own Theme Song, Mindful You, Sanadak, and 12 more MHAs used in 1 study. The MHAs were predominantly informed by cognitive behavioral therapy and focused on reducing depressive symptoms. MHAs were considered acceptable for racial and ethnic minority groups; however, engagement rates dropped over time. Only 2 studies quantitatively reported the effectiveness of MHAs among racial and ethnic minority groups. Barriers to use included the repetitiveness of the MHAs, stigma, lack of personalization, and technical issues.ConclusionsConsidering the growing interest in MHAs, the available evidence for MHAs for racial and ethnic minority groups appears limited. Although the acceptability seems consistent, more research is needed to support the effectiveness of MHAs. Future research should also prioritize studies to explore the specific needs of racial and ethnic minority groups if MHAs are to be successfully adopted.
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Project description:ImportanceDiverse, representative enrollment in pivotal clinical trials is vital to sufficiently power subgroup analyses and ensure equity and validity of trial results.ObjectiveTo evaluate the racial/ethnic representation, trends, and disparities in clinical trials leading to US Food and Drug Administration (FDA) ophthalmology drug approvals from 2000 to 2020.Design, setting, and participantsThis cohort study used data from participants in clinical trials of drugs for neovascular age-related macular degeneration (AMD), open-angle glaucoma (OAG), and expanded indications for diabetic retinopathy (DR) from January 1, 2000, to December 31, 2020. Trial data were sourced from FDA reviews, ClinicalTrials.gov, and relevant linked studies. National expected racial/ethnic proportions were sourced from public National Eye Institute prevalence data as well as published rates scaled using US Census Bureau data.Main outcomes and measuresThe primary outcome measures were the distribution of and change over time in the racial/ethnic proportion of participants in clinical trials leading to FDA approval of drugs for AMD, OAG, and DR.ResultsDuring the 20-year period, 31 clinical trials were identified for 13 medications with 18 410 participants. The distribution of trial participants was different from the expected trial distribution for most approvals with regard to race/ethnicity (12 drugs) and sex (10 drugs). Compared with the first decade (2000-2010), trials conducted in the second decade (2011-2020) showed increases in enrollment of Asian (odds ratio [OR], 2.30; 95% CI, 1.97-2.68; P < .001) and Hispanic or Latinx participants (OR, 1.74; 95% CI, 1.49-2.03; P < .001) for AMD, Asian participants (OR, 2.21; 95% CI, 1.46-3.42; P < .001) for DR, and Black (OR, 1.60; 95% CI, 1.43-1.78; P < .001) and Hispanic or Latinx participants (OR, 10.31; 95% CI, 8.05-13.35; P < .001) for OAG. There was a decrease in Black participants in DR trials (OR, 0.58; 95% CI, 0.42-0.79; P < .001). Based on these trends, the enrollment incidence ratio is expected to worsen by 2050, with overrepresentation of white participants vs underrepresentation of Black and Hispanic or Latinx participants in trials of drugs for AMD (1.08 vs 0.04 vs 0.77), DR (1.83 vs 0.87 vs 0.59), and OAG (1.62 vs 0.90 vs 0.37).Conclusions and relevanceIn this cohort study, Black, Hispanic or Latinx, and other non-White participants were underrepresented in clinical trials leading to FDA ophthalmology drug approvals compared with the expected disease burden and racial/ethnic distribution in the US. Although there was meaningful improvement from 2000 to 2020, further efforts to increase minority enrollment in clinical trials seem to be warranted.
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Project description:BackgroundStarting in 2018, national death certificates included a new racial classification system that accounts for multiple-race decedents and separates Native Hawaiian and Pacific Islander (NHPI) individuals from Asian individuals. We estimated cancer death rates across updated racial and ethnic categories, sex, and age.MethodsAge-standardized US cancer mortality rates and rate ratios from 2018 to 2020 among individuals aged 20 years and older were estimated with national death certificate data by race and ethnicity, sex, age, and cancer site.ResultsIn 2018, there were approximately 597 000 cancer deaths, 598 000 in 2019, and 601 000 in 2020. Among men, cancer death rates were highest in Black men (298.2 per 100 000; n = 105 632), followed by White (250.8; n = 736 319), American Indian/Alaska Native (AI/AN; 249.2; n = 3376), NHPI (205.6; n = 1080), Latino (177.2; n = 66 167), and Asian (147.9; n = 26 591) men. Among women, Black women had the highest cancer death rates (206.5 per 100 000; n = 104 437), followed by NHPI (192.1; n = 1141), AI/AN (189.9; n = 3239), White (183.0; n = 646 865), Latina (128.4; n = 61 579), and Asian (111.4; n = 26 396) women. The highest death rates by age group occurred among NHPI individuals aged 20-49 years and Black individuals aged 50-69 and 70 years and older. Asian individuals had the lowest cancer death rates across age groups. Compared with Asian individuals, total cancer death rates were 39% higher in NHPI men and 73% higher in NHPI women.ConclusionsThere were striking racial and ethnic disparities in cancer death rates during 2018-2020. Separating NHPI and Asian individuals revealed large differences in cancer mortality between 2 groups that were previously combined in vital statistics data.
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Project description:ImportanceApproximately 1 in 5 new patients with head and neck cancer (HNC) in the US belong to racial and ethnic minority groups, but their survival rates are worse than White individuals. However, because most studies compare Black vs White patients, little is known about survival differences among members of racial and ethnic minority groups.ObjectiveTo describe differential survival and identify nonclinical factors associated with stage of presentation among patients with HNC belonging to racial and ethnic minority groups.Design, setting, and participantsThis population-based retrospective cohort study used data from the 2007 to 2016 Surveillance, Epidemiology, and End Results (SEER) database and included non-Hispanic Black, Asian Pacific Islander, American Indian/Alaska Native, and Hispanic patients with HNC. The data were analyzed from December 2020 to May 2021.Main outcomes and measuresOutcomes were time to event measures: (HNC-specific and all-cause mortality) and stage of presentation. Covariates included nonclinical (age at diagnosis, sex, race and ethnicity, insurance status, marital status, and a composite socioeconomic status [SES]) and clinical factors (stage, cancer site, chemotherapy, radiation, and surgery). A Cox regression model was used to adjust associations of covariates with the hazard of all-cause death, and a Fine and Gray competing risks proportional hazards model was used to estimate associations of covariates with the hazard of HNC-specific death. A proportional log odds ordinal logistic regression identified which nonclinical factors were associated with stage of presentation.ResultsThere were 21 966 patients with HNC included in the study (mean [SD] age, 56.02 [11.16] years; 6072 women [27.6%]; 9229 [42.0%] non-Hispanic Black, 6893 [31.4%] Hispanic, 5342 [24.3%] Asian/Pacific Islander, and 502 [2.3%] American Indian/Alaska Native individuals). Black patients had highest proportion with very low SES (3482 [37.7%]) and the lowest crude 5-year overall survival (46%). After adjusting for covariates, Hispanic individuals had an 11% lower subdistribution hazard ratio (sdHR) of HNC-specific mortality (sdHR, 0.89; 95% CI, 0.83-0.95), 15% lower risk for Asian/Pacific Islander individuals (sdHR, 0.85; 95% CI, 0.78-0.93), and a trending lower risk for American Indian/Alaska Native individuals (sdHR, 0.85; 95% CI, 0.71-1.01), compared with non-Hispanic Black individuals. Race, sex, insurance, marital status, and SES were consistently associated with all-cause mortality, HNC-specific mortality, and stage of presentation, with non-Hispanic Black individuals faring worse compared with individuals of other racial and ethnic minority groups.Conclusions and relevanceIn this cohort study that included only patients with HNC who were members of racial and ethnic minority groups, Black patients had significantly worse outcomes that were not completely explained by stage of presentation. There may be unexplored multilevel factors that are associated with social determinants of health and disparities in HNC outcomes.
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Project description:ImportanceBolstering the ranks of women and underrepresented groups in medicine (URM) among medical faculty can help address ongoing health care disparities and therefore constitutes a critical public health need. There are increasing proportions of URM faculty, but comparisons of these changes with shifts in regional populations are lacking.ObjectiveTo quantify the representation of women and URM and assess changes and variability in representation by individual US medical schools.Design, setting, and participantsThis retrospective cross-sectional study assessed US medical school faculty rosters for women and URM, including American Indian and Alaska Native, Black, Hispanic, and Native Hawaiian or other Pacific Islander faculty. US allopathic medical schools participating in the Association of American Medical Colleges (AAMC) Faculty Administrative Management Online User System from 1990 to 2019 (updated December 31 for each year), were included. Faculty data were analyzed from yearly cross-sections updated as of December 31 for each year from 1990 to 2019. For census data, decennial census data were used for years 1990, 2000, and 2010. Intercensal estimates were used for all other years from 1990 to 2019.Main outcomes and measuresTrends and variability in representation quotient (RQ), defined as representation of a group within an institution's faculty compared to its respective US county.ResultsThere were 121 AAMC member institutions (72 076 faculty) in 1990, which increased to 144 institutions (184 577 faculty) in 2019. The median RQ of women faculty increased from 0.42 (IQR, 0.37-0.46) to 0.80 (IQR, 0.74-0.89) (slope, +1.4% per year; P < .001). The median RQ of Black faculty increased from 0.10 (IQR, 0.06-0.22) to 0.22 (IQR, 0.14-0.41) (slope, +0.5% per year; P < .001), but remained low. In contrast, the median RQ of Hispanic faculty decreased from 0.44 (IQR, 0.19-1.22) to 0.34 (IQR, 0.23-0.62) (slope, -1.7% per year; P < .001) between 1990 and 2019. Absolute total change in RQ of URM showed an increase; however, the 30-year slope did not differ from zero (+0.1% per year; P = .052). Although RQ of women faculty increased for most institutions (127 [88.2%]), large variability in URM faculty trends were observed (57 institutions [39.6%] with increased RQ and 10 institutions [6.9%] with decreased RQ). Nearly one-quarter of institutions shifted from the top to bottom 50th percentile institutional ranking by URM RQ with county vs national comparisons.Conclusions and relevanceThe findings of this cross-sectional study suggest that representation of women in academic medicine improved with time, while URM overall experienced only modest increases with wide variability across institutions. Among URM, the Hispanic population has lost representational ground. County-based population comparisons provide new insights into institutional variation in representation among medical school faculty.
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Project description:BackgroundRacial and ethnic minorities (REMs) continue to be underrepresented in clinical trials despite the 1993 National Institutes of Health's Revitalization Act mandating the representation of women and underrepresented minority groups in clinical trials. Although Blacks represent 15% and Hispanics 13% of the cancer population, their clinical trial enrollment rates are disproportionately low at 4% to 6% and 3% to 6%, respectively. A systematic review exploring interventions aimed at improving cancer clinical trial (CCT) enrollment for REMs was conducted.MethodsA systematic search of PubMed, Cochrane CENTRAL, and Ovid PsycINFO was conducted for English-language studies since 1993. Inclusion criteria included peer-reviewed, US-based studies with interventions aimed to recruit underrepresented minority adult patients into cancer clinical trials. REM groups were defined as Black, Hispanic, Asian, American Indian, and Native Hawaiian/other Pacific Islander.ResultsThe systematic search identified 3123 studies, of which nine met inclusion criteria. Interventions included patient navigation/coaching (n = 4), a clinical trial educational video (n = 2), institutional research infrastructure changes (n = 1), a relationship building and social marketing recruitment model (n = 1), and cultural competency training for providers (n = 1). A statistically significant improvement in accrual was shown in three of the patient navigation interventions, one of the clinical trial educational videos and an institutional research infrastructure change.ConclusionsThis systematic review illustrates several potential mechanisms by which to increase CCT recruitment for patients of REM backgrounds in various clinical settings. More randomized controlled trials are needed to further explore the benefits of these interventions for REMs.
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