Mona Shahriari, MD, and Valerie D. Callender, MD, discuss trial diversity, better outcome measures, and how investigators can earn patient trust.
In this November episode of Skin of Color Savvy podcast, Mona Shahriari, MD, associate professor of dermatology at Yale University, spoke with Valerie D. Callender, MD, about whether
This podcast is produced by HCPLive and hosted by
Callender said representation has improved since she began conducting trials in 2001, when skin of color research was largely limited to phase 4 and investigator-initiated studies. Her site now takes part in phase 2 and 3 programs, and she credited the FDA push for diversity action plans with encouraging sponsors to build diverse populations into protocols.¹ Shahriari noted that meeting an enrollment target is only the first layer, since a study can hit a demographic goal and still miss the patient in the exam room.
Both dermatologists described how protocol design can quietly exclude patients. Callender pointed to exclusions for keloid or hypertrophic scar history, visit schedules limited to business hours, and shampoo studies requiring daily hair washing, which would screen out many Black women. She recommended evening or Saturday visits, while Shahriari said sponsors should budget for the staffing and overtime those accommodations require, along with transportation and virtual visit options.
Callender also said outcome measures often miss what matters to patients. Erythema is harder to see in darker skin, and she suggested dermatoscopy or other objective tools to confirm active inflammation. Shahriari added that post-inflammatory pigment change can matter more to patients than clearance scores. Callender said the 2025 SOCS summit, which she helped lead with Valerie Harvey, MD, identified disease areas with poor outcome measures, and a paper is forthcoming. Patients at that meeting also raised concern about losing access to a drug that worked once a study ends, a point Shahriari said sponsors could address.
Callender said investigators, not patients, should take responsibility for trust. She recommended transparency, visible community involvement, diverse staff, and humility during informed consent. Shahriari said many diverse investigators remain underrepresented as trial sites and that patients often feel more comfortable when the investigator resembles them. For retention, Callender stressed communication, being present for visits, returning patient calls personally, and compensating participants for time, transportation, and meals. She also described Skin of Color Society training with the National Medical Association dermatology section that mentors early-career investigators on contracts, budgets, recruitment, and retention.
Callender said she first checks demographics, wanting race, ethnicity, and skin tone all reported, then sample size, inclusion and exclusion criteria, and whether the design is controlled or open label. A systematic review of 626 dermatology trials found that reporting of race or ethnicity was limited, even among US studies.² Both clinicians review adverse event tables, particularly for topicals, to see whether post-inflammatory hyperpigmentation occurred and resolved. Shahriari said clinicians should be open with patients about what the data do and do not show.
Callender expects the field to keep working toward representation and said progress may take 15 to 20 years. She encouraged new investigators to look for gaps in their own clinics, search the literature, and build relationships with sponsors and medical science liaisons.
To learn more about SOCS’s programs and initiatives, visit the
Editor’s note: This summary was edited with the help of AI tools. Shahriari and Callender had no relevant financial disclosures of note.
