In a conversation with Dr. Stephanie Manson Brown, Head of Clinical Development at Allergan Aesthetics, we explore the company’s initiatives to enhance diversity in clinical trials. Dr. Brown discusses the motivations behind the Aesthetics Diversity Summit, the challenges of ensuring diverse representation, and the solutions Allergan Aesthetics is implementing. This dialogue underscores the company’s commitment to inclusivity and leadership in the industry.
Moe: Why did you convene the Aesthetics Diversity Summit?
Dr. Manson Brown: We initiated the Aesthetics Diversity Summit to advance the next generation of clinical investigators through training and mentorship. Proposed at our EEDI Ad Board in 2022, this initiative focuses on licensed physician mentees serving diverse patient groups, who are new to clinical trial research with no more than three years of experience. The program includes an 8-hour in-person training session, a visit to our facilities in Irvine, California, and the ADMIRE Pathfinder Training course, a virtual course on clinical trial fundamentals. Participants who complete both training courses are considered for inclusion in AbbVie’s site feasibility network for future trials, based on their research and site readiness, and qualifications against protocol selection criteria. This comprehensive approach ensures that we are equipping new investigators with the necessary skills and knowledge to contribute effectively to clinical research, ultimately enhancing the diversity and inclusivity of our trials.
Moe: What inspired your focus on racial equity in aesthetics?
Dr. Manson Brown: Our mission is to empower confidence in our customers, patients, and colleagues, enabling them to be their best authentic selves. This mission drives our core principle of fostering a culture of inclusion where diversity is celebrated. It’s crucial to have clinical data that covers a broader demographic because the skin needs and aging patterns of every person are unique. Including patients from diverse backgrounds in clinical research supports superior patient outcomes and drives insights into next-generation product development. For instance, our Maximum Difference Study, presented at the ASDS conference, surveyed around 4,000 adults across different demographic
groups in the US. It revealed varying aesthetic concerns, such as black females prioritizing dark circles, hair loss, and hyperpigmentation, while white females focused on lines, under-eye bags, and sagging skin. These insights highlight the importance of understanding diverse needs to develop effective aesthetic solutions.
Moe: What are the challenges of ensuring diverse trial representation?
Dr. Manson Brown: Ensuring diverse representation in clinical trials involves several challenges. Historical mistrust from underrepresented groups is a significant barrier, as are access issues related to geography, economic factors, and logistics. Additionally, a lack of awareness and education about clinical trials often leads to mistrust. Strict inclusion and exclusion criteria can limit participation, and culturally competent materials may be lacking, presenting relevance and language barriers. To address these challenges, we are investing in infrastructure to support diversity in aesthetic medicine. This includes providing mentorship, training, and knowledge to the next generation of aesthetic medicine talent, enabling them to better meet the needs of our current and future consumers and empower confidence in all. By addressing these barriers, we aim to create a more inclusive environment for clinical trial participation.
Moe: What solutions are you proposing for greater inclusivity in trials?
Dr. Manson Brown: We have developed a comprehensive action plan targeting the pre-trial, study start-up, and post-trial phases to increase enrollment from underrepresented groups. This plan ensures the representation of clinically relevant populations who may benefit from our products. For example, during the pre-trial stage, we are reviewing eligibility criteria to broaden restrictive criteria and remove unintentional barriers, increasing subject access and reducing screen failure and dropout rates. We are also focusing geographically by identifying key locations with diverse subjects and incorporating targeted diversity questions into site feasibility questionnaires. Additionally, we are exploring professional partnerships with organizations like the Skin of Color Society to develop training materials and resources. These efforts aim to create a more inclusive trial design and improve access for diverse populations.
Moe: How do these plans fit your larger mission of celebrating diversity?
Dr. Manson Brown: The Aesthetic Diversity Summit aimed to foster greater education about diversity in clinical trials and partner with healthcare professionals who have access to diverse patient backgrounds. By providing these physicians with the right resources, we help their patients feel confident in seeking safe and effective results. The Summit was a key milestone, but we recognize that diversity is an ongoing journey requiring continuous efforts to create an inclusive environment reflecting the communities we serve. Our commitment to diversity is not a one-time achievement but an integral part of our mission to empower confidence and celebrate diversity within the aesthetics industry. We strive to lead by example and inspire others to prioritize inclusivity in their clinical trials.
Moe: How do you see your leadership in trial diversity influencing others?
Dr. Manson Brown: We anticipate implementing a new process for future studies to define target demographics based on patient benefit, effectiveness, and safety. This ensures our clinical studies accurately reflect the diversity of the real-world population that may benefit from our treatments. Addressing clinical trial diversity requires concerted efforts from manufacturers, researchers, healthcare professionals, and community organizations to build trust, improve access, and create inclusive trial designs. We hope our progress will drive greater conversations and collaboration on this topic, encouraging other companies to follow suit and prioritize diversity in their clinical trials. By setting a precedent, we aim to foster a more inclusive and equitable industry that benefits all patients.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.