medwireNews: A systematic review has identified insufficient representation of people from racial minority groups, older individuals, and men in randomized controlled trials (RCTs) investigating treatments for rheumatoid arthritis (RA).
“Given the disproportionate burden of RA in racial/ethnic minority groups, it is imperative that policy makers better incentivize their inclusion in RA RCTs,” write the researchers in JAMA Network Open.
The systematic review included 240 trials of systemic, disease-modifying RA therapies that were published between 2008 and 2018.
White people were the most commonly represented ethnicity in these trials over the 10-year period studied, with the proportion of White participants ranging from 74.6% to 97.0% in a given year. The proportion of Black participants ranged from 0.6% to 4.7%, while Hispanic representation ranged from 0.0% to 14.4%. Asian, Native Hawaiian, and Pacific Islander representation ranged from 0.0% to 10.4%, and American Indian or Alaska Native representation ranged from 0.0% to 5.7%.
Adrienne Strait (University of California, San Francisco, USA) and colleagues report that there were fluctuations in the proportion of trial participants from different racial groups over time, but “there were no significant trends in the representation of nonwhite groups vs white groups over the observed period.”
Moreover, when the researchers focused on trial populations involved in the 126 trials with at least one site in the USA, the proportion of participants from minority racial groups was significantly lower than their overall representation in the US census population, at 16% versus 40%. This was true for Black (2.7 vs 13.4%), Hispanic (4.4 vs 18.1%), and other racial minority groups.
Strait and team say that a number of “historic and systems-based factors” may influence the participation of racial minority groups in clinical trials, and recommend that “[i]t would be beneficial for future RCTs to collect information about race/ethnicity at all stages of enrollment (ie, invitation, screening, randomization) to allow us to better target solutions.”
The team also identified a significant discrepancy between the proportion of men enrolled in RCTs with at least one US-based site and the proportion of male RA patients in the USA (22.3 vs 28.6%), “suggesting that men have been underrepresented in US-based RA RCTs during the examined 10-year period.”
Therefore, “it may also be beneficial for rheumatology-specific campaigns to advocate for greater inclusion of men in RCTs,” writes the team.
And the investigators report that 41.3% of the RCTs in the systematic review included an upper age limit, with 17.9% excluding adults aged older than 74 or 75 years, which they say “raises concerns about the generalizability of RA RCT results to older populations.”
Strait et al conclude that “it may be necessary to conduct studies that include solely elderly populations to ascertain if current RA treatments are effective and well-tolerated in this group.”
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JAMA Netw Open 2019; 2: e1914745