Comparison of Racial, Ethnic, and Geographic Location Diversity of Participants Enrolled in Clinic-Based vs 2 Remote COVID-19 Clinical Trials.
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ABSTRACT:
SUBMITTER: Stewart J
PROVIDER: S-EPMC8844998 | biostudies-literature | 2022 Feb
REPOSITORIES: biostudies-literature
Publications
Comparison of Racial, Ethnic, and Geographic Location Diversity of Participants Enrolled in Clinic-Based vs 2 Remote COVID-19 Clinical Trials.
Stewart Jenell J Krows Meighan L ML Schaafsma Torin T TT Heller Kate B KB Brown Elizabeth R ER Boonyaratanakornkit Jim J Brown Clare E CE Leingang Hannah H Liou Caroline C Bershteyn Anna A Schwartz Mark D MD Agrawal Vaidehi V Friedman-Klabanoff DeAnna D Eustace Stephen S Stankiewicz Karita Helen C HC Paasche-Orlow Michael K MK Kissinger Patricia P Hosek Sybil G SG Chu Helen Y HY Celum Connie C Baeten Jared M JM Wald Anna A Johnston Christine C Barnabas Ruanne V RV
JAMA network open 20220201 2
<h4>Importance</h4>Racial and ethnic diversity among study participants is associated with improved generalizability of clinical trial results and may address inequities in evidence that informs public health strategies. Novel strategies are needed for equitable access and recruitment of diverse clinical trial populations.<h4>Objective</h4>To investigate demographic and geographical location data for participants in 2 remote COVID-19 clinical trials with online recruitment and compare with those ...[more]
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Project description:ImportanceThe Best Pharmaceuticals for Children Act states that in issuing a written request (WR), the US Food and Drug Administration (FDA) shall consider the adequate representation (eg, proportionate to the disease population) of children from racial and ethnic minority populations. If the terms of the WR are fulfilled, the FDA may grant an additional 6 months of exclusivity for any unexpired patents and exclusivities attached to approved indications.ObjectiveTo report on the race and ethnicity of participants enrolled in pediatric studies conducted in response to WRs for which pediatric exclusivity was granted between 2001 and 2021.Design, setting, and participantsThis retrospective review examines pediatric exclusivity request submissions for oncologic drugs that received pediatric exclusivity between December 2001 and January 2021 based on fulfillment of the requirements of a WR that were identified using the FDA's Document Archiving Reporting and Regulatory Tracking System. Demographic data were manually abstracted from supporting study reports, and data were pooled across submissions for the analysis. Data were analyzed throughout 2022 and 2023.Main outcomes and measuresRepresentation by race, sex, and ethnicity in pediatric studies conducted in response to WRs.ResultsA total of 22 pediatric exclusivity requests were identified, comprising 40 studies and 2025 patients. Most trials (26 [65%]) in the analysis were cooperative group studies. Representation by race was as follows: American Indian/Alaska Native (13 [0.6%]), African American/Black (228 [11.3%]), Asian (92 [4.6%]), Native Hawaiian/other Pacific Islander (33 [1.6%]), White (1303 [64.3%]), other (194 [9.6%]), and unknown/not reported (162 [8.0%]). Representation by sex was female individuals (41.2%) and male individuals (58.8%). Ethnicity was as follows: Hispanic (226 [5.7%]), non-Hispanic (910 [22.5%]), unknown/not reported ethnicity (2800 [69.1%]), and other ethnicity (114 [2.8%]).Conclusions and relevanceThe study results suggest that overall, representation of participants of racial and ethnic minority groups in studies supporting pediatric exclusivity requests appear comparable with the racial distribution of childhood cancers in the US based on data from the National Childhood Cancer Registry Explorer. However, fewer Hispanic participants were enrolled in the trials we reviewed (8%) compared with the representation of Hispanic patients in the National Childhood Cancer Registry (28%). This discrepancy may be partially explained by the large proportion of participants with unknown information regarding ethnicity. Further research into the reasons for the large proportion of participants with missing ethnicity information is needed.
| S-EPMC10767639 | biostudies-literature
Project description:PurposeThere is growing interest in improving the inclusiveness of racial and ethnic minority participants in trials of acute respiratory distress syndrome (ARDS). With our study we aimed to examine temporal trends of representation and mortality of racial and ethnic minority participants in randomized controlled trials of ARDS.MethodsWe performed a secondary analysis of eight ARDS Network and PETAL Network therapeutic clinical trials, published between 2000 and 2019. We classified race/ethnicity into "White", "Black", "Hispanic", or "Other" (including Asian, American Indian or Alaskan Native, Native Hawaiian, or other Pacific Islander participants).ResultsOf 5375 participants with ARDS, 1634 (30.4%) were Black, Hispanic, or Other race participants. Representation of racial and ethnic minority participants in trials did not change significantly over time (p = 0.257). However, among participants with moderate to severe ARDS (i.e., partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 150), the difference in mortality between racial and ethnic minority participants and White participants decreased over time. In the five most recent trials, including 2923 participants with ARDS, there were no statistically significant differences in mortality between racial/ethnic groups, even after adjusting for potential confounders. In these five most recent trials, mortality was 31% for White, 31.9% for Black, 30.3% for Hispanic, and 37.1% for Other race participants (p = 0.633).ConclusionRepresentation of racial and ethnic minority participants in ARDS trials from North America, published between 2000 and 2019, did not change over time. Black and Hispanic participants with ARDS may have similar mortality as White participants within trials.
| S-EPMC10709247 | biostudies-literature
Project description:We estimated racial/ethnic differences in attention-deficit/hyperactivity disorder (ADHD) care quality and treatment continuity among Medicaid-enrolled children. Using Medicaid data from 9 states (2008 to 2011), we identified 172 322 youth (age 6 to 12) initiating ADHD medication. Outcome measures included: (1) adequate follow-up care in the (a) initiation and (b) continuation and maintenance (C&M) treatment phases; (2) combined treatment with medication and psychotherapy (versus medication alone); (3) medication discontinuation; and (4) treatment disengagement (ie, discontinued medication and received no psychotherapy). Logistic regressions controlled for confounding measures. Among those initiating medication, three-fifths received adequate follow-up care in the initiation and C&M phases, and under two-fifths received combined treatment. Compared with whites, African American youth were less likely to receive adequate follow-up in either phase (P < .05), whereas Hispanic youth were more likely to receive adequate follow-up in the C&M phase (P < .001). African American and Hispanic youth were more likely than whites to receive combined treatment (P < .05). Over three-fifths discontinued medication, and over four-tenths disengaged from treatment. Compared with whites, African American and Hispanic children were 22.4% and 16.7% points more likely to discontinue medication, and 13.1% and 9.4% points more likely to disengage from treatment, respectively (P < .001). Care quality for Medicaid-enrolled youth initiating ADHD medication is poor, and racial/ethnic differences in these measures are mixed. The most important disparities occur in the higher rates of medication discontinuation among minorities, which translate into higher rates of treatment disengagement because most youth discontinuing medication receive no psychotherapy.
| S-EPMC5470500 | biostudies-literature
Project description:ObjectivePost-randomisation exclusions in randomised controlled trials are common and may include participants identified as not meeting trial eligibility criteria after randomisation. We report how a decision might be reached and reported on, to include or exclude these participants. We illustrate using a motivating scenario from the BREATHE trial (Trial registration ClinicalTrials.gov, NCT02426112) evaluating azithromycin for the treatment of chronic lung disease in people aged 6-19 years with HIV in Zimbabwe and Malawi.Key pointsIncluding all enrolled and randomised participants in the primary analysis of a trial ensures an unbiased estimate of the intervention effect using intention-to-treat principles, and minimises the effects of confounding through balanced allocation to trial arm. Ineligible participants are sometimes enrolled, due to measurement or human error. Of 347 participants enrolled into the BREATHE trial, 11 (3.2%) were subsequently found to be ineligible based on lung function criteria. We assumed no safety risk of azithromycin treatment; their inclusion in the trial and subsequent analysis of the intervention effect therefore mirrors clinical practice. Senior trial investigators considered diurnal variations in the measurement of lung function, advantages of retaining a higher sample size and advice from the Data Safety and Monitoring Board and Trial Steering Committee, and decided to include these participants in primary analysis. We planned and reported analyses including and excluding these participants, and in our case the interpretation of treatment effect was consistent.ConclusionThe decision, by senior investigators, on whether to exclude enrolled participants, should reflect issues of safety, treatment efficacy, statistical power and measurement error. As long as decisions are made prior to finalising the statistical analysis plan for the trial, the risk of exclusions creating bias should be minimal. The decision taken should be transparently reported and a sensitivity analysis can present the opposite decision.
| S-EPMC7713189 | biostudies-literature
Project description:ObjectiveTo examine racial and ethnic disparities in the receipt of minimally adequate depression treatment in Medicaid-enrolled youth.MethodMedicaid claims data of 2008 through 2011 were used to derive a cohort of youth (5-17 years old) who were diagnosed with a new episode of major depression (N = 45,816) across 9 states. Dichotomous outcomes measured the receipt of minimally adequate psychotherapy (≥4 psychotherapy visits within 12 weeks of initiation); minimally adequate medication (filled antidepressants for 84 of 144 days); any minimally adequate treatment (psychotherapy or medication); and no psychotherapy or medication. Racial/ethnic disparities in the outcome measures were estimated using logistic regression models that controlled for predisposing, enabling, and need-related factors.ResultsLess than four-tenths (38.3%) of the cohort received minimally adequate psychotherapy, 19.2% received minimally adequate pharmacotherapy, and 49.9% received any minimally adequate treatment; conversely, 16.4% received no treatment. Adjusted percentages of black (42.3%; p < .001) and Hispanic (48.2%; p < .001) youth who received minimally adequate treatment were significantly smaller than for non-Hispanic whites (54.7%) because of lower likelihoods of receiving minimally adequate psychotherapy and/or minimally adequate pharmacotherapy. In addition, adjusted percentages of black (20.2%; p < .001) and Hispanic (15.0%; p < .01) youth who received no treatment were significantly larger than for non-Hispanic white youth (12.9%).ConclusionThe percentage of Medicaid-enrolled youth who receive minimally adequate treatment for depression is small overall and even smaller for racial/ethnic minorities than for whites. Future research is needed to identify strategies that improve the overall quality of depression treatment in Medicaid-enrolled youth and decrease disparities in care.
| S-EPMC8051617 | biostudies-literature
Project description:Diverse representation in clinical trials is crucial to understand the efficacy and safety of drugs in minority groups. This review aims to (1) describe research participants' sex, racial, and ethnic diversity in clinical drug trials and (2) describe the sex distribution of researchers conducting the research. We reviewed all clinical drug trials published in the journals "Clinical Pharmacology and Therapeutics" and "Clinical and Translational Science" in 2000-2001 and 2020-2021 and analyzed the research participants' and researchers' demographics. We compared the race of the research participants with the concurrent race diversity of the reference population in the countries where the research was conducted. We identified 281 articles with 17,639 research participants. Approximately one-third of the research participants were women in both 2000-2001 and 2020-2021. The representation from racial minorities of Black and Asian people increased from 2000-2001 to 2020-2021, but Asian and Native American people are still under-represented in clinical drug trials today. The proportion of female authors increased, but female authors still made up less than 40% of the total number of authors in 2020-2021. In conclusion, men are still over-represented in clinical pharmacology research, and some races are still vastly under-represented. Furthermore, although the proportion of female authors increased with time, they are still under-represented as first and last authors.
| S-EPMC10264921 | biostudies-literature
Project description:ImportancePrecision oncology is revolutionizing cancer care, allowing for personalized treatments to improve outcomes. Cancer research has benefitted from well-designed studies incorporating precision medicine objectives, but it is unclear if these studies are representative of the diverse cancer population.ObjectiveTo evaluate racial and ethnic representation in breast, prostate, lung, and colorectal cancer studies incorporating precision oncology objectives in the Clinicaltrials.gov registry and compare with the incidence of these cancer types in racial and ethnic minority groups in the US population.Design, setting, and participantsThis cross-sectional study identified US-based breast, prostate, lung, and colorectal cancer studies incorporating precision oncology objectives for reporting of race and ethnicity. The Surveillance, Epidemiology, and End Results and US Census databases were used to determine cancer incidence by race and ethnicity, linked with cancer type and median year of enrollment for each trial. Data were collected and analyzed between December 2020 and April 2021.Main outcomes and measuresThe expected number of participants per study by each racial and ethnic group was calculated based on the corresponding US-based proportion. Under- and overrepresentation was defined as the ratio of the actual number of enrolled cases to the expected number of cases for each trial by cancer type. Ratios above 1 indicated overrepresentation while a ratio below 1 indicated underrepresentation. Random-effects meta-analysis of representation ratios of individual trials was performed to weigh each individual study.ResultsOf 93 studies encompassing 5867 enrollees with race and ethnicity data; 4826 participants (82.3%) were non-Hispanic White, 587 (10.0%) were Black, and 238 (4.1%) were Asian. Per observed-to-expected ratios, White participants were overrepresented in all studies, with a ratio of 1.35 (95% CI, 1.30-1.37), as well as Asian participants, with a ratio of 1.46 (95% CI, 1.28-1.66), while Black participants (ratio, 0.49; 95% CI, 0.45-0.54), Hispanic participants (ratio, 0.24; 95% CI, 0.20-0.28), and American Indian and Alaskan Native participants (ratio, 0.43; 95% CI, 0.24-0.78) were underrepresented. By individual cancer site, White participants were consistently overrepresented in all studies, while Black and Hispanic participants were underrepresented.Conclusions and relevanceThis analysis found that precision oncology studies for breast, lung, prostate, and colorectal cancers vastly underrepresent racial and ethnic minority populations relative to their cancer incidence in the US population. It is imperative to increase diversity among enrollees so that all individuals may benefit from cancer research breakthroughs and personalized treatments.
| S-EPMC8576580 | biostudies-literature
Project description:Evidence suggests that autistic adults have higher odds of developing several co-occurring conditions, but less is known about disparities by race and ethnicity in this population. Using 2008-2012 Medicaid Analytic eXtract (MAX) data, we (i) identify the prevalence of co-occurring conditions among the population of autistic adult Medicaid beneficiaries compared to a matched sample of those without an autism spectrum disorder (ASD) diagnosis, (ii) conduct logistic regression to estimate odds ratios for these health conditions predicted by an autism diagnosis, and (iii) estimate odds of having these health conditions as predicted by racial/ethnic group among the autistic population only. Overall, autistic adults did not have higher prevalence of some major health conditions (cardiovascular conditions, stroke, cancer, cardiovascular disease), but they did have higher odds of others (nutrition conditions, epilepsy, disorders of the central nervous system). Analysis by racial/ethnic group, however, shows that Black, Hispanic, and Asian autistic beneficiaries had higher odds of diabetes, hospitalized cardiovascular diseases, and hypertension, among other conditions. Policymakers should be aware that racial disparities found in the general population persist in the autistic population and should work to implement systems and programs to improve screening and preventive care for minority autistic populations. LAY SUMMARY: Autistic adults may have several co-occurring physical and mental health conditions, which could differ by racial/ethnic group. We find that, compared to the general Medicaid population, autistic adult Medicaid beneficiaries have elevated odds of some health conditions, like epilepsy and nutrition conditions, as well as some psychiatric conditions, such as anxiety and attention disorders. We also find that many of the same health disparities by racial/ethnic group in the general population persist among the autistic adult Medicaid population. For example, Black, Hispanic, and Asian Medicaid autistic beneficiaries have higher odds of diabetes, and Black and Hispanic autistic beneficiaries have higher odds of obesity and nutrition conditions than white autistic beneficiaries.
| S-EPMC8812993 | biostudies-literature
Project description:Racial and ethnic disparities in the use of nine common autism-related services among Medicaid-enrolled children with autism spectrum disorder (ASD) were examined, distinguishing between school and other community-based outpatient settings. Using 2012 Medicaid Analytic Extract data, we identified 117,848 continuously enrolled children with ASD. Several racial and ethnic disparities were found, varying by geography. Black, Asian, and Native American/Pacific Islanders received fewer outpatient services compared with white children, but there was no disparity for Latinx children. Black and Asian children received more school-based services than white children. Disparities in case management/care coordination services were largest and present in each minority group. Geographic variation in receipt of services suggests targets for policy intervention to improve access for minorities with ASD.
| S-EPMC8137720 | biostudies-literature
Project description:BackgroundHospital admissions for cardiogenic shock have increased in the United States. Temporary mechanical circulatory support (tMCS) can be used to acutely stabilize patients. We sought to evaluate the presence of racial, ethnic, and socioeconomic inequities in access to MCS in the United States among patients with cardiogenic shock.MethodsMedicare data were used to identify patients with cardiogenic shock admitted to hospitals with advanced tMCS (microaxial left ventricular assist device [mLVAD] or extracorporeal membranous oxygenation [ECMO]) capabilities within the 25 largest core-based statistical areas, all major metropolitan areas. We modeled the association between patient race, ethnicity, and socioeconomic status and use of mLVAD or ECMO.ResultsAfter adjusting for age and clinical comorbidities, dual eligibility for Medicaid was associated with a 19.9% (95% CI, 11.5%-27.4%) decrease in odds of receiving mLVAD in a patient with cardiogenic shock (P < .001). After adjusting for age, clinical comorbidities, and dual eligibility for Medicaid, Black race was associated with 36.7% (95% CI, 28.4%-44.2%) lower odds of receiving mLVAD in a patient with cardiogenic shock. Dual eligibility for Medicaid was associated with a 62.0% (95% CI, 60.8%-63.1%) decrease in odds of receiving ECMO in a patient with cardiogenic shock (P < .001). Black race was associated with 36.0% (95% CI, 16.6%-50.9%) lower odds of receiving ECMO in a patient with cardiogenic shock, after adjusting for Medicaid eligibility.ConclusionsWe identified large and significant racial, ethnic, and socioeconomic inequities in access to mLVAD and ECMO among patients presenting with cardiogenic shock to metropolitan hospitals with active advanced tMCS programs. These findings highlight systematic inequities in access to potentially lifesaving therapies.
| S-EPMC11307759 | biostudies-literature