Quantifying Patient Subpopulation Disparities in New Drugs and Biologics Approved Between 2007 and 2017

Getz, Kenneth A.; Smith, Zachary; Peña, Yaritza

doi:10.1007/s43441-020-00181-9

Cited by 11 publications

(21 citation statements)

References 9 publications

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“…Black participants are the most underrepresented within US research in adults . While some have emphasized historical abuse and persistent distrust in medical research, others have emphasized limited access to clinical trials .…”

Section: Discussionmentioning

confidence: 99%

“…Black participants are the most underrepresented within US research in adults. 29,30 While some have emphasized historical abuse and persistent distrust in medical research, 31 others have emphasized limited access to clinical trials. 32 Other factors that may contribute to disparities in research participation include implicit and explicit biases of research team members and financial or transportation barriers.…”

Section: Jama Network Open | Pediatricsmentioning

confidence: 99%

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Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial

et al. 2021

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IMPORTANCE It remains poorly understood how parents decide whether to enroll a child in a neonatal clinical trial. This is particularly true for parents from racial or ethnic minority populations.Understanding factors associated with enrollment decisions may improve recruitment processes for families, increase enrollment rates, and decrease disparities in research participation. OBJECTIVE To assess differences in parental factors between parents who enrolled their infant and those who declined enrollment for a neonatal randomized clinical trial. DESIGN, SETTING, AND PARTICIPANTSThis survey study conducted from July 2017 to October 2019 in 12 US level 3 and 4 neonatal intensive care units included parents of infants who enrolled in the High-dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) trial or who were eligible but declined enrollment. Data were analyzed October 2019 through July 2020. EXPOSURE Parental choice of enrollment in neonatal clinical trial. MAIN OUTCOMES AND MEASURES Percentages and odds ratios (ORs) of parent participation as categorized by demographic characteristics, self-assessment of child's medical condition, study comprehension, and trust in medical researchers. Survey questions were based on the hypothesis that parents who enrolled their infant in HEAL differ from those who declined enrollment across 4 categories: (1) infant characteristics and parental demographic characteristics, (2) perception of infant's illness, (3) study comprehension, and (4) trust in clinicians and researchers. RESULTSOf a total 387 eligible parents, 269 (69.5%) completed the survey and were included in analysis. This included 183 of 242 (75.6%) of HEAL-enrolled and 86 of 145 (59.3%) of HEAL-declined parents. Parents who enrolled their infant had lower rates of Medicaid participation (74 [41.1%] vs 47 [55.3%]; P = .04) and higher rates of annual income greater than $55 000 (94 [52.8%] vs 30 [37.5%]; P = .03) compared with those who declined. Black parents had lower enrollment rates compared with White parents (OR, 0.35; 95% CI, 0.17-0.73). Parents who reported their infant's medical condition as more serious had higher enrollment rates (OR, 5.7; 95% CI, 2.0-16.3). Parents who enrolled their infant reported higher trust in medical researchers compared with parents who declined (mean [SD] difference, 5.3 [0.3-10.3]). There was no association between study comprehension and enrollment. CONCLUSIONS AND RELEVANCEIn this study, the following factors were associated with neonatal clinical trial enrollment: demographic characteristics (ie, race/ethnicity, Medicaid status, and (continued) Key Points Question How do parents with infants enrolled in a neonatal clinical trial differ from those who decline participation? Findings In this survey study including 269 parent responses, participants who enrolled their infant had different demographic characteristics (lower rate of Medicaid participation, higher income, less likely to identify as Black), reported their infant's medical condition as more serious, and reported ...

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Section: Discussionmentioning

confidence: 99%

Section: Jama Network Open | Pediatricsmentioning

confidence: 99%

Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial

et al. 2021

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“…2,3 Set against a landscape of well-documented inequities in health care delivery and access, it is no wonder that mistrust of the biomedical research establishment persists in Black communities and has resulted in lower participation rates of Black individuals in many clinical trials. 4 The underrepresentation of Black participants in research trials has taken on a new urgency as the world faces the greatest public health challenge of this generation in the form of the coronavirus disease 2019 (COVID-19) pandemic, which is caused by the novel coronavirus SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). In the US, this pandemic has disproportionately affected Black persons and many other people of color, with Black people experiencing a mortality rate 2 to 3 times as high as White or Asian American individuals.…”

mentioning

confidence: 99%

“…The research enterprise must admit to its own ugly scars of institutional racism, from the unethical Tuskegee syphilis experiments on Black men to recent troubling revelations that Black researchers are significantly less likely to receive funding from the National Institutes of Health (NIH) than their White counterparts, and that research involving health care disparities is less likely to be funded . Set against a landscape of well-documented inequities in health care delivery and access, it is no wonder that mistrust of the biomedical research establishment persists in Black communities and has resulted in lower participation rates of Black individuals in many clinical trials …”

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confidence: 99%

Recognition of Research Participants’ Need for Autonomy

Wolinetz

Collins

2020

JAMA

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, marked what would have been the 100th birthday of Henrietta Lacks, the Black woman whose cervical cancer cells gave rise to the immortal HeLa cell line. HeLa cells have played an extraordinary role in scientific research, underlying multiple Nobel Prize-winning discoveries and enabling medical advances for polio, cancer, Ebola virus disease, sickle cell disease, and countless other conditions. However, the bright biomedical legacy of HeLa cells is tarnished by the injustice of this biospecimen being preserved without the consent of Lacks or her family, whose identity was revealed decades ago. 1 This failure, while permitted by the ethical norms of the time, has affected the Lacks family in profound ways, including limiting the comfort, pride, and satisfaction that comes with knowing a deceased loved one made an important contribution to science. Today's current events provide an opportune time to reflect on the experiences of Lacks and other African Americans in the context of biomedical research, and to look ahead to what can be done to make that future far more just and equitable. In the wake of the killing of George Floyd and other similar events, the US may have reached an inflection point in challenging systemic racism and a long history of injustices against Black individuals. The research

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“…Furthermore, only 13% of all clinical trials from approved NDAs and BLAs included data on participant ethnicities. 16 The FDA's lenient requirements on reporting participant demographics, specifically, race and ethnicity, and lack of accountability hinders the progression towards a more diverse clinical trial population. In 2017, the US Congress passed the FDA Reauthorization Act which required the FDA to conduct a public meeting with experts on clinical trial eligibility prior to developing industry guidance on the topic.…”

Section: Historical Backgroundmentioning

confidence: 99%

Key barriers against racial and ethnic minority participation in U.S. clinical trials

Bae

2022

Int J Clin Trials

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<p class="abstract">Despite the United States’ (U.S.) longstanding history of promoting a melting pot nation of people from diverse racial and ethnic backgrounds all capable of achieving the American Dream, it is argued that the U.S. is failing to deliver high quality healthcare to all of its constituents equally. The widely seen health disparities of ethnic minority groups endure has extended into the parallel field of clinical research and clinical trials. There is a staggering gap between the percentage of White clinical trial participants compared to clinical trial participants of racially and ethnically diverse minority groups in U.S. clinical trials. Underrepresentation of minority groups in clinical trials dismisses opportunities to identify potential serious sub-group safety or efficacy signals, open doors to access life-saving treatments, and ultimately improve the standard of evidence-based medicine in the United States. Current literature on this issue frequently reiterates the following five key barriers underrepresented minority groups face against clinical trial participation: mistrust, lack of awareness and access, cultural and language barriers, investigator and provider bias, and financial burdens. A deeper dive into understanding each barrier will be critical in implementing changes with actions and in perspectives in order to address the issue of poor racial and ethnic representation in clinical trial populations.</p>

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Quantifying Patient Subpopulation Disparities in New Drugs and Biologics Approved Between 2007 and 2017

Cited by 11 publications

References 9 publications

Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial

Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial

Recognition of Research Participants’ Need for Autonomy

Key barriers against racial and ethnic minority participation in U.S. clinical trials

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