Ensuring diversity in clinical trials improves the representation and generalizability of study results, allowing for a more significant impact on health outcomes for more patients. An analysis of 32,000 participants of new drug trials conducted in the U.S. in 2020 revealed that only 8% were Black, 6% Asian, 11% Hispanic, and 30% were aged 65 years and older. These estimates indicated underrepresentation as they were not aligned with U.S. Census population data.

Dermatology as a therapeutic area is subject to underrepresentation, as evidenced by a recent review of randomized clinical trials (RCTs) comparing the period 2010 – 2015 with 2015 – 2020, which found that inclusion of patient populations remains inadequate.

In this article, we describe the diversity status in dermatology clinical trials, barriers that participants face, and actionable steps to increase participant diversity in clinical research.  

 

State of Diversity in Dermatology Clinical Trials 

While it is clear that participants in clinical trials should represent the patients who will eventually use the intervention being studied. Unfortunately, racial and ethnic minorities and other diverse groups (including gender and age) are underrepresented in clinical research.

Despite U.S. Food and Drug Administration (FDA) guidelines and National Institutes of Health (NIH) diversity mandates, dermatology continues to underreport race and ethnicity clinical trial data4. To understand the state of diversity in dermatology clinical trials, Chen et al. conducted a systematic review of 392 randomized clinical trials (RCTs) from 2015 to 2020. Compared with 2010 – 2015, the transparency in reporting of race and ethnicity in U.S. studies improved over time. However, the authors concluded that the inclusion of representative patient populations had not statistically significantly changed over the two periods and remained inadequate, particularly for psoriasis trials. Further, Chen et al. found that U.S.-based eczema and acne studies had the greatest racial and ethnic diversity, while psoriasis trials were predominantly Caucasian. On gender representation in psoriasis studies, female representation decreased significantly between the two time periods.

Another recent study analyzed the top 60 dermatology journals and found that only five had diversity, equity, and inclusion (DEI) statements or editorial board members dedicated to DEI. The authors recommended that more journals implement resources, e.g., checklists and frameworks for increasing DEI, within their peer-review process and to aid authors in increasing diversity within their publication5.  

 

The example of hidradenitis suppurativa & psoriasis 

Despite legislative efforts, hidradenitis suppurativa (HS) and psoriasis clinical trials lack representation of females and minorities. Researchers report that females and minorities were underrepresented in HS and psoriasis clinical trials compared to their population prevalence. For example, in HS clinical trials, the proportion of females was 63.7% vs. 73.5%, Hispanic patients were 3.8% vs. 12.0%, and Black patients were 9.1% vs. 20.3%.  

 

Importance of Diversity in Dermatology 

Diversity in dermatology research is important, as people of different ages, genders, races, and ethnicities may have different experiences and reactions to an intervention. Ensuring diversity in clinical trials is an ethical and scientific obligation that requires a deep understanding of the barriers to participation in order to create an effective multidimensional approach. 

Diversity is valued to address the systematic and continual difference between the population of clinical trial participants and the overall country population or the population affected by the dermatological condition. Greater diversity of trial participants translates to discovering more about the intervention’s safety and efficacy. Additionally, for scientific merit and validity, the population of participants in clinical trials should shift as the country’s demographic shifts. If not, the research sample is not representative, and the study results may not be generalizable.

Researchers have gone as far as to say that ensuring the diversity of dermatology clinical trial participants should no longer be optional. In addition to increasing the generalizability of study results, a diverse study population improves our understanding of the disease and intervention under study, ensures safety and clinical benefit for diverse patient populations, and contributes to fairness and equity.  

 

Barriers to Diversity  

Underrepresented populations face barriers to participation, which include: 

• Lack of awareness of dermatology clinical trial opportunities 

• Resource constraints 

• Location and accessibility of clinical research sites and networks 

• Mistrust of clinical research 

• Social factors, e.g., lack of access to healthcare 

• Complexity of study design 

 

The example of atopic dermatitis 

A recent study on atopic dermatitis (AD) highlights critical considerations in addressing social disparities that may contribute to underrepresentation in clinical research. A chronic inflammatory skin condition, AD has different presentations and prevalence depending on skin tone, i.e., specific ethnic groups may have unique AD phenotypes, which in turn affect diagnostic and management options. This particularly affects AD in Black and Asian populations due to environmental exposure and social factors, e.g., lack of access to healthcare. Marcelletti et al. suggest that addressing social disparities can increase representation in clinical research and help serve these patient populations.

Beyond recruitment, retention is also critical, and Bissonnette et al. describe other factors that should be considered once diverse populations are successfully included in an AD trial. For example, researchers should consider the influence of ethnicity on the view of quality of life (QoL) and patient-reported outcomes (PRO), the inclusion of ethnicities that live far from clinical research sites, and the reporting of drug safety information. Amongst others, they recommend improved training for physicians on evaluating AD in patients with different skin colors and establishing systematic reporting of ethnicity, race, and skin color in clinical trial publications. 

 

How to Increase Diversity in Dermatology Trials 

Although the importance of representation in dermatology trials is increasingly recognized, effective strategies to increase diversity still need to be developed. Overall, actionable steps for improving diversity in clinical trials include  

• Regulatory guidance encouraging diversity  

• Community engagement and needs assessment are integral to the recruitment and retention of underrepresented groups.  

• Decentralization and digital health tech enhance the accessibility of clinical research.  

• Improving representation among clinical research staff. 

 

1. Regulatory guidance to increase diversity 

Regulatory agencies like the FDA and the European Medicines Agency (EMA) encourage diverse participation in clinical trials to advance health equity. On June 26, 2024, the FDA issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” aimed at helping sponsors submit Diversity Action Plans to support certain clinical studies. Ultimately, Diversity Action Plans are intended to help improve the data submitted to the FDA about all patients who may use the medical product. The FDA guidance also “urges sponsors and investigators to consider the many dimensions of clinical trial diversity, even those that extend beyond age, ethnicity, sex, and race to enroll populations that represent the patients who will be treated if the product is approved.” 

 

2. Investing in community engagement 

Barriers to participation include a lack of awareness of dermatology clinical trial opportunities, resource constraints, the location and accessibility of clinical research sites and networks, mistrust of clinical research, and study design complexity. To ensure continued participation, efforts should not be limited to recruitment but also retention, protocol compliance, and participant experience.

Community-based participatory research has been shown to improve recruitment of underrepresented patient populations. Actionable steps include: 

• To pave the way for a meaningful and mutually beneficial partnership, Kelsey et al. emphasize the importance of understanding how the community perceives the research institution and assessing the community’s health needs. Align research protocol with the community health needs. 

• You can access the Centers for Disease Control and Prevention (CDC) Principles of Community Engagement for different levels of community involvement in clinical research.  

• Co-design recruitment protocols with the community 

• Foster a multidirectional partnership in which communities are involved in all aspects of the research project. A two-way flow of information facilitates bidirectional education. 

• Both parties take equal ownership of the design, implementation, and outcome of the study. 

 

3. Participant engagement, recruitment, and retention 

A recent meta-analysis of clinical trials found that more than 50% of individuals offered trial participation agreed to enroll and that these participation rates did not differ significantly by racial subgroups. Based on their findings, the researchers suggest that many patients may not be offered the opportunity to participate in a trial, yet might be interested if given the chance. In light of this, the first step is to reach out, improve awareness of clinical research, and offer the opportunity to enroll in a trial.

Actionable steps: 

• Ensure participation is offered and promoted to a diverse population. 

• Engage the community as a partner from trial design to retention, protocol compliance, and dissemination of results. 

• Plan for and integrate community engagement into budgets, timelines, and scopes of work. 

• Continue nurturing partnerships with the community even after trial completion. 

 

4. Meeting participants where they are  

The physical distribution of clinical research sites can prevent the participation of underrepresented minority groups. Expanding research operations to nontraditional and novel types of sites enables new participation options and new relationships with communities and community-based clinicians.

In dermatology clinical research, decentralized clinical trials (DCTs) are particularly beneficial as they enable sponsors and clinical trial research sites to extend the pool of potential participants to a more diverse and underrepresented population. Dermatology is especially well-suited to virtual clinical trials because it consists of many indications where patients are otherwise generally healthy, such as acne or psoriasis. DCTs leverage various digital health tech tools to enable the completion of core trial activities remotely, offering a more sustainable and inclusive strategy for conducting dermatology clinical research. However, switching to DCTs may introduce tech-related barriers like a need for more high-speed internet access. Clinical trials using digital tools must employ the same best practices for inclusivity as all other clinical research endeavors. Both the FDA and EMA have published guidance reports on DCTs.

Innovatively leveraging existing infrastructure is possible if investigators invest in community engagement and understand community health needs well. For example, Victor et al. used networks of barbershops in their study to recruit participants and deliver the intervention with the help of local barbers. “Meeting participants where they are” resulted in the recruitment of over 300 non-Hispanic Black men and a retention rate of 95% in the intervention group.

Establishing a research infrastructure and deploying digital health technology. Actionable steps include:

• Prioritize participant access and experience  

• Leverage virtual methods like DCTs to address geographic barriers 

• Utilize digital health tools to alleviate participant burden  

• Ensure inclusive and equitable use of digital tools by assessing digital literacy and device accessibility  

 

5. Underrepresentation among investigators 

As investigators from underrepresented populations are often more effective at recruiting underrepresented participants, diversification of the clinical research workforce may result in improved diversity of trial participants. In reality, racial and ethnic minority groups are also underrepresented among investigators and the clinical research workforce. Among full-time faculty at academic institutions, a study estimated that less than 5% were African American, 3% Hispanic, and 1% Native American. Further, the researchers detected that underrepresentation among medical school faculty is increasing over time. Similar disparities exist among the sexes. 

Diversification of the Dermatological Clinical Research Workforce. Actionable steps: 

• Hiring individuals from underrepresented groups and offering support and mentorship for their research endeavors  

• American Academy of Dermatology Association (AAD)’s Diversity, Equity, and Inclusion (DEI) initiative aims to foster diversity in dermatology and increase dermatological services to underserved populations. Activities include mentoring medical students of color, encouraging them to choose dermatology, and recognizing their academic research through the ADA Investigator Awards. 

• Seek for and provide clinical trial training courses targeted at women and racial and ethnic minority groups, e.g., programs provided by the American College of Cardiology (ACC) Diversity and Inclusion initiative.

As part of its commitment to sustainability in dermatology clinical research and social sustainability, TFS HealthScience consistently emphasizes diversity and inclusion across the company, fostering a workforce that reflects a solid commitment to diversity at all organizational levels.  

 

Summary 

Increasing patient diversity in dermatology clinical trials helps ensure the generalizability of clinical trial results, reduces health disparities, and contributes to equitable access to new and effective treatment options for improved health outcomes. Strategies to increase diversity require a multidimensional approach grounded on a firm understanding of the complex nature of underrepresentation in dermatology clinical trials. Investment in community engagement and partnerships, assessment of community health needs to improve trial accessibility, leveraging digital health technology, and improving the diversity of the clinical research workforce coalesce to better translate clinical trial results to improved health outcomes for all.   

 

TFS HealthScience – Your Global CRO Partner in Dermatology 

At TFS HealthScience, the Dermatology, Immunology, and Inflammatory Disease team specializes in managing clinical development Phases I-IV and patient recruitment in multiple indications. We partner with you to develop a regulatory and operational strategy tailored to your specific trial’s requirements, then deliver all your clinical program’s scientific and medical aspects to help ensure market success. 

Our internal experts and global network of key opinion leaders (KOLs) support site start-up, patient access, referral, recruitment and retention, and investigator identification at global, regional, and local levels.

Discover how our global, full-service contract research organization (CRO) streamlines clinical development, ensuring your clinical trial progresses swiftly to market. Meet our dedicated team and view our indication knowledge. Our track record in dermatology: We have worked with more than 70 clients and established our presence in over 8,000 sites in over 30 countries. TFS has conducted over 200 dermatology clinical trials involving over 81,000 patients worldwide. The quality of our full-service portfolio is built on the expertise of our team: scientific advisors, regulatory strategists, and research professionals, all focused on your project’s success. 

We listen to deliver. Contact us today!