Seven Strategies to Increase Patient Diversity in Dermatology Clinical Trials
Explore how diverse patient representation leads to the development of safer and more effective treatments for dermatologic diseases.
The underrepresentation of diverse groups in clinical research is an area of regulatory, scientific and industry focus, partly due to the recent U.S. Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.” Adding to this momentum, in December 2022 the U.S. Congress passed the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act, which requires sponsors applying for Investigational New Drugs and Investigational Device Exemptions to submit diversity action plans for Phase III or other pivotal trials, no later than the end of Phase II meeting.
The issue of including diverse populations that represent disease prevalence and country and regional demographics is not new to industry. For decades, the FDA and other regulators have been issuing guidance documents focused on expanding inclusion of racial and ethnic minorities (Black/African Americans, Asian, Filipino, Hispanic/Latino, Native American/Alaskan Native, Native Hawaiian/other Pacific Islander Americans), women, pediatric patients and the elderly in clinical trials.
The medical and scientific community have long understood that increasing diversity in clinical trials is key to the development of medical products that are safe and more effective for everyone who will use them. The failure to achieve diversity in clinical trials has led to limited information about drug response and measures of safety and efficacy in historically underrepresented populations. To overcome these challenges, drug developers must understand the keys to accessing diverse communities and positioning clinical research in a meaningful manner, thereby driving development of therapeutics that are safe and effective in all populations.
Drivers of Disparities in Dermatologic Conditions
Common factors that lead to disparate patient outcomes include:
- Barriers to access to health care in underserved populations
- Lack of awareness and lack of information about dermatologic conditions
- Late diagnosis and misdiagnosis
- Delayed treatment
- Lack of adequate and consistent treatment by a dermatologist
- Genetic linkages
The other complicating factor for these conditions is that, although the prevalence and presenting severity is higher in patients of color, most of the clinical trials for investigational and approved products have been conducted in largely Caucasian populations — meaning safety and efficacy data treatments do not include data from patients with higher disease prevalence and disease burden.
Similarly, many of the disease assessment tools and rating scales used in validating dermatology clinical trial efficacy endpoints were not designed or validated in all skin types, so do not fully represent the differences in disease presentation and severity in populations of color.
Diversity in Dermatologic Disease Prevalence, Presentation and Outcomes
Skin conditions affect all skin types and all racial and ethnic groups. However, there are several examples of differences in disease prevalence, atypical disease clinical appearance and disparate disease severity in different populations.
- Eczema/Atopic Dermatitis (AD) has a distinct appearance in skin of color or darker skin tones compared to white skin and is often misdiagnosed, resulting in delayed and sub-optimal treatment. Studies have shown it is also more common and sometimes more severe in Black, Hispanic and Asian patients, and patients with skin of color often present with more treatment-resistant AD.
- Psoriasis is a common condition across skin types and races and ethnicities. Prevalence is highest in white (3.6%) followed by non-Hispanic Black (1.9%) and Hispanic (1.6%) populations. Although there are similarities in disease presentation and characteristic distribution, there are also marked differences in the presentation in different skin tones, which can lead to delay in diagnosis and under-treatment, inappropriate treatment and lack of treatment.
- Hidradenitis Suppurativa is more common in Black, Hispanic and certain Asian populations. Its severity and presentation have been linked to genetics, autosomal dominant pattern of familial HS inheritance and multiple disease co-morbidities, with diagnostic and treatment delays.
- Vitiligo is the most common depigmenting disorder, with a prevalence of approximately 0.5% in the world population, affecting males and females equally. Disease burden varies with skin tones — because it is a chronic depigmenting skin disorder, it is more noticeable in darker skin. People from certain racial groups may be more stigmatized and emotionally and psychologically affected by vitiligo. Some data also show trends for longer treatment delays for individuals with skin of color.
- Melanoma accounts for 75% of all skin cancer deaths in the U.S. Although individuals of lighter skin tones are more likely to develop melanoma, studies have found that Black populations have a worse prognosis than white individuals. Black patients have the highest percentage of late-stage diagnoses, leading to higher mortality.
Strategies to Increase Diverse Populations in Dermatology Clinical Trials
1. Connect with diverse communities to build relationships based on trust and respect. Share information about dermatologic conditions and clinical research through community organizations, patient advocacy groups and other trusted partners.
2. Identify and engage sites in areas with high racially/ethnically diverse populations. Less experienced or research-naïve, community-based clinics and dermatology practices will lean on support and training from sponsors and CROs to engage diverse populations in the study.
3. Build relationships with diverse dermatologists and engage them in clinical research networks through collaborations with organizations such as the Skin of Color Society, the National Medical Association and the National Hispanic Medical Association. It is important to cultivate partnerships to train diverse investigators and build clinical research capacity at sites in diverse communities.
4. Develop culturally competent, targeted minority patient engagement and educational materials. This could include translating materials into different languages and creating easy-to-read, health-literate collateral.
5. Decrease logistical and financial burdens of study participation by deploying digital and decentralized trial tools, near patient solutions, and travel coordination and reimbursement. Data published in 2019 found that study participants who received reimbursement were significantly more likely to complete study assessments than participants who did not receive reimbursement.
6. Understand the impact of disease epidemiology and protocol design on the recruitment and retention of diverse populations. A great way to do this is by pressure-testing protocols with patient advocacy groups and building their feedback into the study design.
7. Incorporate the voice and perspective of patients, patient advocates and community into the design of the program. Our 2023 industry trends report finds that, for large pharmaceutical organizations, building relationships with patient advocacy groups is the leading strategy to enhance participation and meet diversity goals, followed by remote monitoring and patient education. In smaller/mid-sized organizations, protocol designs that incorporate inclusion criteria and patient assistance resources are the top two strategies for participation and diversity.
Choose the Right Clinical Trial Partner
Partnering with a contract research organization (CRO) that has expertise in operationalizing patient diversity plans is key to success in supporting submission and product approval in compliance with regulatory expectations for patient diversity.
Whether you need to develop a plan or support in executing your plan, the PPD clinical research business of Thermo Fisher Scientific can enable your diversity plan development. Our established global network of experienced dermatology investigative sites is complemented by the SiteCoach® training platform, which expands the site footprint into underrepresented communities by providing good clinical practice (GCP) training and support to less experienced dermatology sites.