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. 2023 Dec 23:7:100134.
doi: 10.1016/j.gloepi.2023.100134. eCollection 2024 Jun.

Improved clinical trial race/ethnicity reporting and updated inclusion profile, 2017-2022: A New Jersey snapshot

Affiliations

Improved clinical trial race/ethnicity reporting and updated inclusion profile, 2017-2022: A New Jersey snapshot

Elli Gourna Paleoudis et al. Glob Epidemiol. .

Abstract

Background: Diverse representation in clinical trials is an important goal in the testing of a medical, diagnostic, or therapeutic intervention. To date, the desired level of trial equity and inclusivity has been unevenly achieved.

Methods: Employing the US National Library of Medicine's Clinicaltrials.gov registry, we examined 481 clinical trials conducted - at least in part - in the state of New Jersey. These trials were initiated after the FDA-mandated Common Rule changes, i.e., between January 2017 and October 2022, were enacted, and had their results posted. We analyzed sex/race/ethnicity reporting as well as applicable enrollment. Using meta-analysis, we estimated group participation proportions of a subset of the 481 identified trials; specifically, the 229 studies that were conducted solely within the US (i.e., without international sites) and compared them to US census data.

Findings: Within the 481 clinical trials analyzed, over 97% reported on the race and/or ethnicity of their enrollees; all included information on sex. Reporting was not affected by funding source or therapeutic area. Based on the 229 solely US-based studies, the participants overall were 76.7% White; 14.1% Black; 2.7% Asian; and 15% Hispanic. Inclusion of Black participants did not differ from the 2020 US census data; in contrast, the levels of Asian and Hispanic participation were below the corresponding census percentages.

Interpretation: The past five years have seen an overall uptick in the equity of race/ethnicity reporting and inclusivity of clinical trials, as compared to previously reported data, presaging the potential acquisition of ever more powerful and meaningful results of such interventional studies going forward.

Funding: Support for this study comes from the Hackensack Meridian Health Research Institute and the Hackensack Meridian School of Medicine.

Research in context: Evidence before this studyClinical trials are a critical part of determining whether or not a medical (drug/device/biologic) or socio-behavioral intervention is safe and truly effective. Through their use, scientific understanding is advanced and, ideally, human health is improved. To gain the most impactful information from a clinical trial, it should be sufficiently representative, that is, should enroll an adequate number of participants, and include a diverse population. Without such inclusion, the study is of only limited generalizability. Efforts are underway by funders, sites, and other stakeholders, to enhance reporting and promote inclusive enrollment. The extent to which such attempts are yielding results - at least for clinical trials in the state of New Jersey - is the focus of this data-driven analysis. The ClinicalTrials.gov registry database was carefully mined for the information contained in this report.Added value of this studyOur analysis of clinical trials initiated in the state of New Jersey and conducted there or elsewhere in the US reveals several positive trends. Our 5-year snapshot reveals that a very large percentage of trials report on race/ethnicity - and inclusivity is improving. While there is still some way to go to have the demographic numbers in these trials match US census values, our results suggest that recent efforts are having an effect.Implications of all the available evidenceFor myriad reasons, clinical trials have not enjoyed the public's universal trust over the years. In many ways, medicine moves at the speed of trust - without it, the promise of modern healthcare is brought into question. Clinical trials must include a commitment to diverse enrollment pools and equitable reporting under the law. Creating a legacy of trust - through greater inclusivity in clinical trials and more transparent reporting of results - will begin to heal the divide and engender faith in modern medicine and today's healthcare system. It would also allow for the desired far-reaching generalizability of results across patient populations. To better appreciate what needs to be done going forward, we must truly understand the state of clinical trials reporting and demographic inclusion. This report initiates such an analysis, by carefully documenting how New Jersey's clinical trials are performing. By virtue of its location (e.g., proximity to the cities of New York and Philadelphia) the state is part of a large biopharma cluster and healthcare nexus; it is critical that it performs well with respect to adopting/adhering to updated clinical trial guideline mandates. This report provides a glimpse - an important first look - into the state of clinical trials in New Jersey - from 2017 through 2022.

Keywords: Clinical trials; Clinicaltrials.gov; Ethnicity; Evidence-based medicine; Race.

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Conflict of interest statement

The authors declare no competing/conflicting interests.

Figures

Fig. 1
Fig. 1
a. CONSORT flow diagram of study search paring parameters and inclusion of trials. b. Clinical trial distribution. Map of the US with distribution of clinical trials that were conducted – at least in part – in New Jersey and solely within the US (i.e., without international sites. 229 such studies meet this criteria in total – hence the number 229 appears inside New Jersey.
Fig. 2
Fig. 2
Summary of the racial, ethnic, and sex proportions in trials conducted in the US. Standard box and whisker plots depict medians, 1st and 3rd quartiles (horizontal lines within colored boxes), data points located 1.5 times interquartile range from 1st and 3rd quartile (whisker ends), and data beyond that distance (circles; possible outliers).
Fig. 3
Fig. 3
Variability in racial, ethnic, and sex proportions in the clinical trials (US locations only). The left panel shows the variability of racial, ethnic, and sex proportions in examined clinical trials that started in the period between 2017 and 2021 in the US. The right panel shows histograms of distributions of proportions in clinical trials. Each Black symbol represents a clinical trial conducted in the US. Red line indicates the percentage of interest from the 2020 US census. Blue line is a LOESS curve, which is a smoothed curve used here to qualitatively assess patterns in the data. (For interpretation of the references to colour in this figure legend, the reader is referred to the web version of this article.)
Fig. 4
Fig. 4
Modified forest plots for overall and subgroup meta-analysis, Location and COVID-19. Vertical lines indicate the 2020 US census percentages. Circles and bars indicate overall or subgroup (Location and COVID) estimates of population group proportions and 95% confidence intervals, respectively, from the random-effects model.
Fig. 5
Fig. 5
Proportions by Therapeutic area. Modified forest plots for subgroup meta-analysis, Location and COVID-19. Vertical lines indicate the 2020 US census percentages. Circles and bars indicate overall or subgroup (Therapeutic area)) estimates of population group proportions and 95% confidence intervals, respectively, from the random-effects model.

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