Supporting inclusive research
Identifying barriers to recruiting skin of colour patients to dermatology studies and ways to overcome these barriers (1,300 words, 7 minutes)
At the “Meeting the Challenge Summit” hosted by The Skin of Colour Society in Washington, D.C. in June 2022, key stakeholders across the clinical trial ecosystem met to advance discussions regarding the need for broader inclusion of racial and ethnic minority patients in dermatology clinical trials. Their findings were published in a special communication in JAMA Dermatology on May 24, 2023.
They write that a recent analysis of data from more than 20,000 US-based trials (The Lancet Regional Health–Americas July 2022; 11:100252) found a 1.7% increase in trial diversity between 2000 and 2020. The authors of that paper noted minority enrollment remained below census estimates and was most significant for Latino and Asian individuals.
Other papers that examined changes in the diversity of dermatology clinical trials (JAMA Dermatology Feb. 2017; 153(2):193-198, JAMA Dermatology Jan. 26, 2022; 158(3):288-292), found that while race and ethnicity reporting in dermatologic clinical trials in the U.S. increased to 71.9% during 2015 to 2020 from 59.8% during 2010 to 2015, the proportion of studies with adequate non-White racial and ethnic representation remained statistically stagnant.
As part of the Summit, stakeholders identified several barriers to diversity in dermatology clinical trials and discussed strategies to overcome those barriers.
Barriers they identify include:
Socially determined factors such as economic stability (income), level of education, health care access, and community context.
Factors specifically influencing African American participation such as low levels of trial awareness, negative attitudes, religious beliefs, and logistical barriers (including transportation and childcare needs).
The stakeholders agreed there has been a presumption that historical and modern-day biases against marginalized populations drive low representation in biomedical research. However, they said a large body of evidence says this isn’t true.
They cite studies that show non-White individuals are as likely or more likely to consent to being in a trial if asked. However, other research shows that minority individuals are being invited to participate at lower rates.
Additionally, they note that findings from the Tuskegee Legacy Project found that Black survey respondents were more willing to participate in a biomedical study if their physician asked them.
Bottom line: Black, Asian, Non-Hispanic White and other minority populations remain underrepresented in biomedical clinical trials. The barriers to their participation are largely related to socioeconomic factors such as participation time and cost requirements and not an unwillingness to participate. Addressing these factors and improving the diversity of the dermatology workforce could help make clinical trial participation more representative.
From the literature on minority representation in dermatology
Current landscape of clinical trials for vitiligo: improving outcome standardization and trial diversity
The authors of this paper evaluated the demographic characteristics of participants in trials of vitiligo treatments compared to the global vitiligo population. They also evaluated trends and characteristics of treatments in clinical trials for vitiligo to project future growth areas for the field.
The literature review included phase II and III studies, and they examined data on study timeframe, blinding, intervention type, vitiligo types and patient demographics including Fitzpatrick skin type and race or ethnicity.
While the authors noted that most patient demographics in vitiligo clinical trials were mostly consistent with epidemiological estimates of vitiligo, there is a noticeable lack of trial participants of higher Fitzpatrick skin types. Quality of life, which may be more heavily impacted by vitiligo in patients with darker skin, may be underreported since less than 10% of trials considered this outcome.
Many variables including Fitzpatrick skin type and blinding status were underreported across studies.
Development of an Eczema Area and Severity Index atlas for diverse skin types
This paper describes the development of an Eczema Area and Severity Index (EASI) lesion severity atlas and refined guidance for investigators and clinicians to use across diverse patient populations.
The researchers reviewed clinical images from internal atopic dermatitis (AD) photo repositories and selected representative images of the four AD signs included in EASI for different physician-assessed skin phototypes.
In total, they reviewed more than 3,000 clinical photographs. They then used an iterative review process to select the final images for the atlas. Researchers then created two different atlas versions across six physician-assessed phototypes (I-VI) and three skin complexions (light, medium, and dark).
The authors propose guidance language for erythema that reflects the range of colours encountered across different skin complexions (shades of red, purple, and brown).
Evaluating the impact of exclusion criteria on the generalizability of hidradenitis suppurativa treatment research
Researchers conducted this study to characterize the trends of exclusion criteria and explore the impact of exclusion criteria on participant diversity, length of enrollment, and the number of enrolled participants in clinical trials of hidradenitis suppurativa.
A literature search included 19 randomized controlled trials, totalling 2,664 screened patients and 2,234 enrolled from 25 countries.
The authors found a weak to moderate positive correlation between the number of exclusion criteria and the proportion of enrolled participants. Still, no association was seen between the number of exclusion criteria, the number of enrolled Black participants, and enrollment length.
They did not see any trend in the number of exclusion criteria over time. The authors concluded that while the number of exclusion criteria appeared to impact the number of enrolled participants, the lack of skin of colour representation in hidradenitis suppurativa randomized controlled trials does not appear to be influenced by the number of exclusion criteria.
Racial and ethnic disparities in research and clinical trials
This review details contributing factors to the underrepresentation of racial and ethnic minorities in clinical trials across medical specialties including dermatology.
Factors the authors identify that contribute to this disparity include:
A documented history of racial and ethnic minorities, particularly Blacks, experiencing mistreatment and human experimentation without consent from the medical community
Multiple well-recognized physicians who are credited with significant medical advancements have a history of unethical medical practices against marginalized minority groups
Inadequate reporting and representation of racially and ethnically diverse participants in dermatologic clinical trials
The authors write that a lack of education among marginalized minority groups, mistrust of the medical community, and language barriers will all need to be addressed to recruit and retain racial and ethnic minorities as participants in research.
VIDEO: Skepticism around clinical trials | History & health: Equitable access to care series
This panel discussion from the Humanities Research Center, Virginia Commonwealth University in Richmond, Va., explores how marginalized people in the U.S. are impacted by the history and procedures of clinical trials, how these experiences influence skepticism toward clinical trials, and how to promote activism focused on outreach and awareness.
At the intersection of skin and society
CBC News has released a “report card” on the status of the 231 calls for justice that the Canadian National Inquiry into Missing and Murdered Indigenous Women and Girls (MMIWG) released four years ago.
The news outlet’s analysis concludes that only two calls—identifying 18 areas needing reform, including education, justice, and health—have been completed. More than half have not been started.
The CBC defined calls deemed “not started” as those where promises may have been made or money may have been committed, but no change has been effected, and no money has been spent.
They defined “in progress” as calls where some level of government has concretely funded or made legislative or programming changes.
The two completed calls are:
In 2019, sections 79 to 84.1 of the Corrections and Conditional Release Act were implemented into the Corrections and Conditional Release Act.
In 2022, the federal government announced the creation of the role of deputy commissioner for Indigenous corrections. In March 2023, Corrections Canada announced Kathy Neil had been hired to fill the role, starting in May 2023.
The full report card can be read here.
This week
June 12 to 18 is Men’s Health Week in the U.K.
June 12 is International Albinism Awareness Day
June 16 is International Day of the African Child
Something to think about in the week ahead…
Walt Disney
Next week
In a talk during the 8th annual Skin Spectrum Summit, Dr. Monica K. Li of Vancouver detailed some of the differences in skin barrier function among individuals with different skin types and geographic origins.
If you like Skin Spectrum Weekly, why not check out Chronicle’s other publications, podcasts, and portal?
Established in 1995, The Chronicle of Skin & Allergy is a scientific newspaper print providing news and information on practical therapeutics and clinical progress in dermatologic medicine. The latest issue features:
Dr. Jerry Tan (Windsor, Ont.) discusses recent findings on the presentation and prevalence of truncal acne
Drs. Jaggi Rao (Edmonton), Maxwell Sauder (Toronto), and Jason Rivers (Vancouver) give their thoughts on skin cancer prevention and how to increase the adoption of sun-safe habits among the population.
An essay from Dr. Munirah Aljaser (Montreal) submitted to the 2022 Dermatology Industry Taskforce on Inclusion, Diversity and Equity (DiTiDE) short essay contest. Dr. Aljaser wrote on the challenge of changing the cultural perception that lighter-coloured skin is more beautiful.
Plus regular features, including the popular column “Vender on Psoriasis” by Hamilton, Ont. dermatologist Dr. Ron Vender
Read a recent digital edition here. To apply for a complimentary* subscription or to receive a sample copy, please email health@chronicle.org with your contact information.
The Women in Dermatology e-newsletter updates new findings concerning dermatologic issues that affect women and the female dermatologists who care for them. Read the current issue here.
Season two of the Shear Listening Pleasure podcast with Dr. Neil Shear has launched. Listen to the eighth episode here, where Dr. Shear speaks with dermatologist Dr. Sonja Molin (Kingston, Ont.) about allergology, patch testing, and the growth of Queen’s University’s dermatology division.
And if you’re looking for a web destination for all things derm, please visit derm.city, “Where Dermatology Lives.” Please like, rate, review, and share it with your colleagues.