Racial and Ethnic Differences in Drug Disposition and Response: Review of New Molecular Entities Approved Between 2014 and 2019

Ramamoorthy, Anuradha; Kim, Hannah; Shah-Williams, Ebony; Zhang, Lei

doi:10.1002/jcph.1978

Cited by 24 publications

(23 citation statements)

References 5 publications

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“…5 Moreover, these demographic domains have also been shown to be independent modulators of drug/vaccine efficacy and toxic effects in specific settings. [6][7][8][9][10] Vaccines and drugs are usually approved based on established safety and efficacy through the rigorous conduct of randomized clinical trials. 11 Prevention and treatment regimens shown to be effective in clinical trials cannot be confidently applied to all populations when individuals with diverse backgrounds are not adequately represented.…”

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confidence: 99%

Sex, Racial, and Ethnic Representation in COVID-19 Clinical Trials

et al. 2023

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ImportanceSince the onset of the COVID-19 pandemic, there have been calls for COVID-19 clinical trials to be fully representative of all demographic groups. However, limited evidence is available about the sex, racial, and ethnic representation among COVID-19 prevention and treatment trials.ObjectiveTo investigate whether female participants and racial and ethnic minority individuals are adequately represented in COVID-19 prevention and treatment trials in the US.Data SourcesIdentified studies were registered on ClinicalTrials.gov or published in the PubMed database from October 2019 to February 2022.Study SelectionIncluded studies must have provided the number of enrolled participants by sex, race, or ethnicity. Only interventional studies conducted in the US for the primary purpose of the diagnosis, prevention, or treatment of (or supportive care for) COVID-19 conditions were included.Data Extraction and SynthesisData on counts of enrollments by demographic variables (sex, race, and ethnicity) and location (country and state) were abstracted. Studies were broadly categorized by primary purpose as prevention (including vaccine and diagnosis studies) vs treatment (including supportive care studies). A random effects model for single proportions was used. Trial estimates were compared with corresponding estimates of representation in the US population with COVID-19.Main Outcomes and MeasuresSex, racial, and ethnic representation in COVID-19 clinical trials compared with their representation in the US population with COVID-19.ResultsOverall, 122 US-based COVID-19 clinical trials comprising 176 654 participants were analyzed. Studies were predominantly randomized trials (n = 95) for treatment of COVID-19 (n = 103). Sex, race, and ethnicity were reported in 109 (89.3%), 95 (77.9%), and 87 (71.3%) trials, respectively. Estimated representation in prevention and treatment trials vs the US population with COVID-19 was 48.9% and 44.6% vs 52.4% for female participants; 23.0% and 36.6% vs 17.7% for Hispanic or Latino participants; 7.2% and 16.5% vs 14.1% for Black participants; 3.8% and 4.6% vs 3.7% for Asian participants; 0.2% and 0.9% vs 0.2% for Native Hawaiian or Other Pacific Islander participants; and 1.3% and 1.4% vs 1.1% for American Indian or Alaska Native participants. Compared with expected rates in the COVID-19 reference population, female participants were underrepresented in treatment trials (85.1% of expected; P &lt; .001), Black participants (53.7% of expected; P = .003) and Asian participants (64.4% of expected; P = .003) were underrepresented in prevention trials, and Hispanic or Latino participants were overrepresented in treatment trials (206.8% of expected; P &lt; .001).Conclusions and RelevanceIn this systematic review and meta-analysis, aggregate differences in representation for several demographic groups in COVID-19 prevention and treatment trials in the US were found. Strategies to better ensure diverse representation in COVID-19 studies are needed, especially for prevention trials.

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confidence: 99%

Sex, Racial, and Ethnic Representation in COVID-19 Clinical Trials

et al. 2023

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“…Of the new molecular entities (NMEs) approved by the FDA's CDER between 2008 and 2019, ~ 15% of drugs showed: (i) differences in exposure and/or response based on race/ethnicity; (ii) differences based on pharmacogenetic factors known to vary in frequency across global populations; or (iii) had postmarketing studies in a specific population. 7 When differences in exposure/response are clinically significant and warrant different prescribing recommendations, such information is included in the FDA-approved product labeling. For example, African American patients taking tacrolimus may need to be titrated to higher dosages to attain comparable trough concentrations to White patients; additionally, they may be at an increased risk for new-onset diabetes following transplantation.…”

Section: Considerations From a Clinical Pharmacology Perspectivementioning

confidence: 99%

The Importance of Diversity in Clinical Trials

Johnson-Williams

Jean

Liu

et al. 2022

Clin Pharma and Therapeutics

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This paper discusses some root causes that contribute to the lack of diversity in clinical trials, the impact of limited diversity, and opportunities that can be leveraged to close the gaps in the inclusion of a diverse patient population in clinical trials. Specifically, we outline the importance of representation, clinical pharmacology and regulatory considerations, the role of realworld data, and suggestions for stakeholder collaboration.

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“…Sufficient participation of diverse groups in clinical studies is critical to determine the true safety and efficacy of new therapies. Without a genuinely representative sample population, researchers risk losing critical health information pertaining to the differential effects of potential new treatments on the target population, thus perpetuating the widening gap of health disparities in the US healthcare system [9,10].…”

Section: Introductionmentioning

confidence: 99%