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. 2019 Nov 1;2(11):e1914745.
doi: 10.1001/jamanetworkopen.2019.14745.

Demographic Characteristics of Participants in Rheumatoid Arthritis Randomized Clinical Trials: A Systematic Review

Adrienne Strait  1 , Francine Castillo  1 , Sonam Choden  2 , Jing Li  3 , Evans Whitaker  4 , Titilola Falasinnu  5 , Gabriela Schmajuk  2   3 , Jinoos Yazdany  3
Affiliations

Demographic Characteristics of Participants in Rheumatoid Arthritis Randomized Clinical Trials: A Systematic Review

Adrienne Strait et al. JAMA Netw Open. .

Abstract

Importance: Racial/ethnic minority groups, women, and elderly people experience a disproportionate burden of disease in rheumatoid arthritis (RA), making it particularly important to examine drug therapies in these populations. Despite a national health agenda to improve representation of diverse populations in randomized clinical trials (RCTs), there have been few large-scale analyses examining RCT demographic characteristics within rheumatology and none focusing on RA.

Objective: To characterize the representation of racial/ethnic minority groups, women, and elderly people through a comprehensive systematic review of RA RCTs.

Data sources: A literature search of PubMed's MEDLINE database was conducted to identify RA RCTs in adults 19 years and older published in English between January 1, 2008, and January 1, 2018.

Study selection: Randomized double-blind RCTs examining any systemic, disease-modifying therapy were included. Secondary analyses of previously published RCTs were excluded. Of 1195 identified records, 240 articles (20.1%) met final selection criteria. The analysis focused on RCTs with at least 1 US-based site.

Data extraction and synthesis: Data were extracted and synthesized according to the PRISMA guidelines for systematic reviews. Studies were screened for eligibility criteria. Demographic data on the age, sex, and race/ethnicity of RCT participants were extracted. Data analysis was conducted from October 25, 2018, to March 15, 2019.

Main outcomes and measures: Representation of race/ethnicity and sex, defined as the proportion of total participants that belonged to each racial/ethnic group or sex. Trends in proportions over time were examined and compared with US demographic data.

Results: A total of 240 RCTs with 77 071 participants were included. Of 126 RCTs with at least 1 US-based site (52.5%), the enrollment of minority racial/ethnic groups was significantly lower than their representation within the US Census population (16% vs 40%; P < .001), and the enrollment of men was significantly lower than the incidence of RA in men nationally (20.4% vs 28.6%; P < .001). There was no trend toward improved representation of racial/ethnic minority groups or men over time.

Conclusions and relevance: Given the disproportionate burden of RA among racial/ethnic minority groups, it is imperative that policy makers better incentivize the inclusion of racial/ethnic minority groups in RA RCTs.

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Conflict of interest statement

Conflict of Interest Disclosures: Ms Strait reported grants from Rheumatology Research Foundation and National Institute of Arthritis and Musculoskeletal and Skin Disease (NIAMS), during the conduct of the study. Ms Castillo reported grants from Rheumatology Research Foundation, and NIAMS during the conduct of the study. Dr Schmajuk reported receiving support from Russell/Engleman Medical Research Center for Arthritis outside the submitted work. Dr Yazdany reported grants from NIAMS during the conduct of the study and grants from Pfizer, personal fees from Eli Lilly and Astra Zeneca, and support from Russell/Engleman Medical Research Center for Arthritis outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flow Diagram for Selection of Studies
RA indicates rheumatoid arthritis; RCT, randomized clinical trial.
Figure 2.
Figure 2.. Trends in Racial/Ethnic Representation in Rheumatoid Arthritis Randomized Clinical Trials With at Least 1 US-Based Site
Figure 3.
Figure 3.. Trends in Racial/Ethnic Representation in Rheumatoid Arthritis Randomized Clinical Trials (RCTs) Compared With National Estimates
National estimates were obtained from 2013 through 2017 Census Bureau data.
Figure 4.
Figure 4.. Trends in Male Representation in Rheumatoid Arthritis Randomized Clinical Trials With at Least 1 US-Based Site
See this image and copyright information in PMC

References

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