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Patient-centric Psoriasis (PsO)/Psoriatic Arthritis (PsA) Clinical Trials 

Psoriasis and Psoriatic Arthritis

 

This video, featuring Dr Todd Schlesinger, emphasizes the importance of ensuring diversity in clinical trials and highlights ways in which the clinical trial process can be more inclusive of diverse populations.


Transcript: 

Hello, and thank you for joining us. My name is Todd Schlesinger, and I'm a board-certified dermatologist and clinical investigator. Today, I'd like to discuss diversity in dermatology clinical trials and how we can improve representation of patients with skin of color.

So, let's first talk about why diversity in clinical trials is important. By 2044, it's estimated that more than 50% of the US population will have skin of color.

Clinical trial populations need to reflect the diversity of the US population. Lack of diversity in clinical trials can skew findings, mask adverse events, and provide efficacy and safety results that are not generalizable to the population.

Efforts have been made to increase diversity of patient populations included in clinical trials through mandates and guidance from both the National Institutes of Health, or NIH, and the Food and Drug Administration, or FDA. While this is a good start, the actual percentages from clinical trials are still not where they need to be.

For example, one study found that while dermatology clinical trials are reporting population race and ethnicity at an increasing rate, the proportion of non-White participants remained unchanged when looking at trials conducted from 2015 to 2020 compared to 2010 to 2015. Psoriasis studies were found to be the least diverse, with only 12.1 % of studies including 20% or more non-White participants. From what we've reviewed so far, we know the lack of diversity in dermatology trials is a problem.

So, why is this happening? Well, there are many patient-related barriers to clinical trial participation. They may perceive some risks in participating in clinical trials or just generally mistrust the medical institution, healthcare providers, or the research process, especially if they don't have a great relationship with their healthcare providers. They may also lack education regarding clinical trial process or disease state, or access to care, including transportation, child care, or the inability to miss work.

Finally, language barriers and lack of diversity in the healthcare delivery system may deter participation as well. How can we address some of these barriers and expand access to trials to more diverse populations? One of the most important things we can do is to provide education on upcoming trials and the benefits and risks of participation. Healthcare providers should be able to discuss clinical trials with patients from all backgrounds.

Educational materials that are culturally sensitive and patient-directed should be available for patients to read and take home with them. This education is most impactful when delivered by trusted members of the community. Healthcare providers should work closely with community organizations to increase overall trust and spread awareness about clinical trial opportunities.

For example, advertising in community centers or via social media has the potential to increase clinical trial participation. Access is a major barrier to clinical trial participation. We can increase access to trials by allowing for greater flexibility when scheduling patients, considering replacing in-person visits with telemedicine when appropriate, and supporting both providers and patients through funding opportunities, especially in areas that have limited resources.

We can take into account cultural considerations to entry by ensuring inclusive language, terminology, and word choice when describing race and ethnicity, building a team of research staff that's diverse and bilingual, and mandating cultural competency training for research staff. Lastly, the healthcare system needs to also promote the development of a more diverse healthcare provider network. This will go a long way in encouraging diverse populations to participate.

If you look at recent data from the American Association of Medical Colleges, it found that Black and Hispanic dermatologists made up only 3% and 4% of the dermatology workforce, respectively. These numbers are nowhere near high enough. We can educate future healthcare providers on opportunities designed to address the issue of underrepresentation within medicine, including the Skin of Color Society's clinical trial mentorship program.

We've talked about the lack of diversity in dermatology clinical trials, the barriers these patients face, as well as some potential solutions. It is extremely important for us healthcare providers to establish a trusting and collaborative relationship with each patient. By connecting with patients and understanding their background, we can provide tailored education to build trust in the healthcare research process.

It is essential to understand that each patient has a history and personal preferences that will need to be considered throughout the trial. Thank you so much for joining us today.

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