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Review
. 2018 Mar 17;20(4):20.
doi: 10.1007/s11926-018-0728-2.

The Representation of Gender and Race/Ethnic Groups in Randomized Clinical Trials of Individuals with Systemic Lupus Erythematosus

Titilola Falasinnu  1 , Yashaar Chaichian  2 , Michelle B Bass  3 , Julia F Simard  4   5
Affiliations
Review

The Representation of Gender and Race/Ethnic Groups in Randomized Clinical Trials of Individuals with Systemic Lupus Erythematosus

Titilola Falasinnu et al. Curr Rheumatol Rep. .

Abstract

Purpose of review: This review evaluated gender and race/ethnic representation in randomized controlled trials (RCTs) of patients with systemic lupus erythematosus (SLE).

Recent findings: Whites comprise 33% of prevalent SLE cases and comprised 51% of RCT enrollees. Blacks encompass 43% of prevalent SLE cases, but only represented 14% of RCT enrollees. Hispanics comprise 16% of prevalent SLE cases and 21% of RCT enrollees, while Asians comprise 13% of prevalent SLE cases and 10% of RCT enrollees. Males encompass 9% of SLE cases and 7% of RCT enrollees. The reporting and representation of males have remained stable over time, although their representation in RCTs is slighter lower than the prevalence of SLE in males. The representation of Hispanics, Asians, and Native Americans increased over time. However, the representation of blacks among RCT participants has decreased since 2006-2011. RCTs among SLE patients need larger sample sizes in order to evaluate heterogeneity in outcomes among racial subgroups. It is imperative that novel strategies be developed to recruit racial minorities with SLE by identifying and improving barriers to RCT enrollment in order to better understand the disease's diverse population.

Keywords: Clinical trials; Enrollment; Ethnicity; Race; Representation.

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Conflict of interest statement

Conflict of Interest

Dr. ChiChian prior partial salary support (2015–2016) from Genomics Institute of the Novartis Research Foundation, as part of translational SLE immune profiling study.

Dr. Falasinnu reports grants from National Heart, Lung, and Blood Institute, during the conduct of the study.

Dr. Michelle B. Bass and Dr. Julia F Simard declare that they have no conflict of interest.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.

Figures

Fig. 1
Fig. 1
The attrition diagram for literature search. After eliminating observational studies (n = 2438), unavailable full text articles (n = 101), studies that were not SLE-related (n = 143) and non-randomized studies (n = 108), 193 studies were retained for this review
Fig. 2
Fig. 2
Race and gender reporting over time. Percentages of studies reporting representation of males, whites, blacks, Hispanics, or Asians from 1997 to 2017. Reporting of most race/ethnic groups appears to peak in the period 2007–2011, after which there appears to be a decrease. However, the reporting of Native American inclusion increased over time
Fig. 3
Fig. 3
Race and gender representation over time. Average percentages of race and male enrollments in race-reporting trials from 1997 to 2017. Whites represented between 47 and 56% of RCT enrollees between the periods 1997–2001 and 2012–2017; however, blacks comprised 18 and 10% of enrollees, respectively. There appears to be an increase in the representation of racial minority groups other than blacks until the period 2007–2011, after which there appears to be a decrease. Hispanics comprised 6% of enrollees in the period 1997–2001, but this increased to 23% of enrollees in the period 2012–2017. The inclusion of Asians increased from 9% in 1997–2001 to 11% in 2012–2017. Native Americans increased from 0 to 4% during those two periods
Fig. 4
Fig. 4
Compares the overall race and gender representation with recently published prevalence estimates. While whites comprised 33% of prevalent SLE cases in the USA [9, 10, 19, 20], they comprised 51% of RCT enrollees. Blacks comprised 43% of prevalent SLE cases [9, 10, 19, 20], but only 14% of RCT enrollees. Hispanics encompassed 16% of prevalent SLE cases [9, 10, 19, 20] and 21% of RCT enrollees, while Asians comprised 13% of prevalent SLE cases and 10% of RCT enrollees
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References

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