Delivering on Diversity in Clinical Trials: Getting Started

Patient diversity in clinical trials is top-of-mind for today's leading researchers. “It [diversity in clinical trials] is not where we want it to be yet. Now that the NIH has required companies to indicate how diverse their trials are, I think that has made a difference,” Susan Taylor, MD, professor of dermatology at the University of Pennsylvania in Philadelphia, recently told Dermatology Times in an interview at Masterclasses in Dermatology.

Susan Taylor, MD

Taylor is a co-founder of the Skin of Color Society (SOCS) and is gearing up to celebrate the organization’s 20th anniversary during the SOCS Scientific Symposium in San Diego on March 7, 2024 ahead of the American Academy of Dermatology (AAD) Meeting. The theme of this year’s symposium is “Pathways to Equity: Advancing Advocacy, Research, and Clinical Excellence.”

A study assessing the representation of diverse racial and ethnic groups in dermatology clinical trials conducted in the US between 2017 and 2021 was initiated last year. Data from 246 trials indicated that 87.4% reported racial information. Comparisons with census data revealed underrepresentation of Black/African American, American Indian/Alaskan Native, and those identifying with 2 or more races. Additionally, Hispanic or Latino participants were also underrepresented. Despite considering prevalence rates, Black/African Americans remained the most underrepresented group. The study underscores the importance of accurate representation in clinical trials to address health disparities, enhance clinical understanding, and improve access to treatments for the increasingly diverse population.¹

“I think there's a real effort by a variety of pharmaceutical companies to identify principal investigators who have [access to] diverse populations, who know how to enroll diverse patients in clinical trials,” Taylor said. “One of the major challenges that we face in recruiting for clinical trials that include diverse populations is identifying the investigators who have those patient populations [represented]...You know, often there are very good dermatologists who don't have the resources to start a clinical trials unit as a part of their practice.”

Taylor believes there is an additional need for training and awareness on how to incorporate investigation into practices that serve diverse patient populations. Clinical trials play a pivotal role in advancing dermatological knowledge and expanding the treatment armamentarium, and there are numerous ways to get started.² Here are a few resources to get the ball rolling on research in your practice. 

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Networking and Familiarizing Yourself With the Process

Establishing collaborations with research institutions, universities, or pharmaceutical companies is crucial for accessing clinical trial opportunities. ClinicalTrials.gov also outlines clinical trials at all stages, and the site is available for anyone to search by disease state, treatment modality, or location. Networking with colleagues and researchers in the field can also open doors to potential partnerships. While engaging in networking opportunities, familiarization with the regulatory processes governing clinical trials in the United States is an essential first step. The US Food and Drug Administration provides comprehensive guidelines on conducting clinical trials, ensuring participant safety, and maintaining ethical standards.³

Adhering to ethical considerations is equally paramount in clinical research. Guidelines established by the World Medical Association (WMA) educates clinical trial investigators on the principles of informed consent, patient confidentiality, and institutional review board approval processes. The WMA guidelines also delve into the use of placebos, interventions, and post-trial provisions.⁴

Attend Meetings and Add Sponsored Events to Your Agenda

Before attending any meeting or conference, there are proactive measures that can ensure the right connections are made to get started in clinical research. Bahadir Simsek, MD, cardiology resident in the internal medicine program at Yale New Haven Hospital, et al, recommend reviewing presenter and registration lists, contacting potential mentors beforehand via email or social media, and narrowing down attendance to sessions aligned with specific interests. This allows you to approach key opinion leaders with intention instead of shaking hands and handing over business cards.⁵

Most meetings and conferences host sponsored events and product theaters to share insight on current clinical trials and give clinicians the ability to network with pharmaceutical companies to express interest in involvement. Networking in the exhibit hall can also serve as an avenue to share more information about patient populations served in your practice.⁵

Join Professional Organizations

Professional organizations such as the Skin of Color Society, American Academy of Dermatology, Society for Pediatric Dermatology, Pediatric Dermatology Research Alliance, American Society for Dermatologic Surgery, Society for Investigative Dermatology, and many more give members the insider track of upcoming and current research underway. There are often grants and funding available for those looking to get their research kickstarted and gain exposure. The AAD keeps a running list of research grants from outside organizations.⁶

“That's [training and education is] a huge gap, and if we fill that gap, then we'll have more excellent investigators who have access to those diverse patient populations,” Taylor concluded.

What advice do you have for dermatology clinicians looking to get involved in research? We would love to hear from you! Email DTEditor@mmhgroup.com.

References

1. Mineroff J, Nguyen JK, Jagdeo J. Racial and ethnic underrepresentation in dermatology clinical trials. J Am Acad Dermatol. 2023 Aug;89(2):293-300. doi: 10.1016/j.jaad.2023.04.011. Epub 2023 Apr 14. PMID: 37062462.
2. Carson PA. Clinical research in dermatology: 10 steps to getting started. Dermatol Ther. 2006 Nov-Dec;19(6):377-82. doi: 10.1111/j.1529-8019.2006.00095.x. PMID: 17199680.
3. Center for drug evaluation and research: conducting clinical trials. US Food and Drug Administration. June 30, 2020. Accessed February 28, 2024. https://www.fda.gov/drugs/development-approval-process-drugs/conducting-clinical-trials.
4. World Medical Association. World Medical Association declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4.doi: 10.1001/jama.2013.281053. PMID: 24141714.
5. Simsek B, Kostantinis S, Karacsonyi J, et al. How to effectively network During an in-person conference: insights for junior researchers. Anatol J Cardiol. 2023;27(2):69-70. doi:10.14744/AnatolJCardiol.2022.2500
6. Research grants from outside organizations. American Academy of Dermatology. Accessed February 28, 2024. https://www.aad.org/member/career/awards/outside.