Race, ethnicity, socioeconomic status poorly reported in systemic sclerosis trials
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Randomized controlled trials investigating systemic sclerosis do a poor job of documenting the race, ethnicity and socioeconomic status of participants, according to data published in Arthritis Care & Research.
“We have planned this study to better understand how reporting of race/ethnicity and patient socioeconomic status is accurate and how the different racial/ethnic groups have been represented in randomized studies conducted in systemic sclerosis so far,” Michele Iudici, MD, PhD, MPH, of Geneva University Hospitals and the University of Geneva, in Switzerland, told Healio.
To investigate how race, ethnicity and socioeconomic status are reported and used in randomized controlled trials of SSc, Iudici and colleagues collected data from the MEDLINE database. The search was conducted on Aug. 31, 2021, and identified randomized controlled trials focusing on SSc that had been conducted since 2000. Studies were excluded if they featured “scleroderma-like” disorders or if they were secondary publishing versions of trials. Nonrandomized trials, observational studies, meeting abstracts and non-English language studies were additionally excluded.
Following the data acquisition, the researchers sifted through titles and abstracts to manually exclude papers that did not fit the inclusion criteria. They then reviewed potential papers’ full versions to ensure eligibility. Every paper was analyzed with certain data elements were extracted, including represented countries, the journal impact factor, the year of publication and funding source, the phase of development, the investigated intervention, the number of patients and the specific subtype of SSc,, specific complications being studied and whether patients’ race, ethnicity or socioeconomic status was reported.
The analysis included a total of 106 studies analyzing 6,693 patients. Approximately one-third of the studies reported the race and/or ethnicity of the participants. According to the researchers, there was no improvement on the reporting of race and ethnicity as papers became more recent. Just two papers included information on the socioeconomic status of the included patients.
Study location was the biggest factor on whether race or ethnicity was reported, the researchers wrote. In studies where this data were reported, white patients were the most well-represented, at 79%, followed by Asian patients at 7% and Black patients at 6%.
“Our results should hopefully foster a better reporting of important demographic and socioeconomic factors in randomized studies on systemic sclerosis, and promote initiatives to improve trial participation of underrepresented groups,” Iudici told Healio.
Perspective
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David A. McLain, MD, MACR, FACP, FRCP
Studies have shown that there is a lack of Black, Indigenous and people of color (BIPOC) representation in clinical trials that could compromise the generalizability of the results. The recognition of this problem is not new.
There was a flurry of articles from 2005 to 2010 about this underrepresentation in studies of various disease states. Per the NIH, adequate enrollment could be determined by using the participation-to-prevalence ratio, which is the percentage of BIPOC individuals among trial participants divided by the percentage of BIPOC patients in the overall disease population. Among the many randomized controlled trials with inadequate representation are those examining systemic lupus erythematosus, acute pain, cancer, stroke, cardiovascular disease, obesity, COVID-19 and vaccines.
Studies have indicated that the low racial and ethnic enrollment in clinical research was due to several key reasons, including structural racism and socio-economic disadvantage. The implicitly biased perceptions of physicians or research staff regarding potential BIPOC candidates have hindered opportunities to communicate effectively with participants and prevented BIPOC recruitment within study design. Additionally, BIPOC candidates may be less willing to participate in a trial if the enrollment staff does not have a similar cultural or ethnic background.
Personal relationships with patients and the community, participant training and mentoring, and engagement and operational practices of the research staff also play important roles in BIPOC group enrollment. As noted with the present analysis, studies published in the past few years show improved, though inadequate, inclusion of underrepresented groups. This will continue to be an area of interest in research study design.
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