The FDA plans to prioritize improvements in the quality of demographic subgroup data collection, reporting and analysis, encourages greater participation of diverse patients, and supports the transparency of subgroup data. To this end, ways to recruit, engage, educate, and study those of diverse backgrounds to alopecia areata trials will be discussed.

1. Amy J. McMichael, M.D.
Professor and Chair
Department of Dermatology
Wake Forest Baptist Medical Center
Winston-Salem, NC Alopecia Areata Research Summit 2018

2. DISCLOSURE/CONFLICTS OF INTEREST – NONE RELEVANT TO THIS DISCUSSION
Investigator
Allergan
Intendis
Procter & Gamble
Samumed
Casseopia
Concert
Alcaris
Incyte
Consultant
Johnson & Johnson
Procter & Gamble
Stiefel
Allergan
Bayer
Galderma
Incyte
Samumed
Aclaris
Anacor
Pfizer
Nutrafol
Bioniz

3.  Diversity among the medical workforce shown to improve patient care1
 Increased access to care for patients with low incomes, racial and ethnic diversity,
non-English-speaking patients, and individuals with Medicaid
 Race-concordant visits show higher patients satisfaction than race-discordant visits
 In educational environments, diversity leads to:
 Civic engagement, ease with managing diversity, recognition of racism, and cognitive
complexity (AAMC Report on Black Males in Medicine 2015)
1Cooper LA et al. Commonwealth Fund 2004. Available at www.commonwealth.org

4. Excerpted from AAMC:
Altering the course of
Black Males in Medicine
2015

5.  Dermatology falling behind population changes in the US
 3% Black dermatologists vs 12.8% Black US current population
 4.2% Hispanic origin dermatologists vs 16.3% in current population
 Differences are worse for dermatology than for medicine in general
 Definition of Underrepresented in medicine (UIM or URM) =
 Describes racial and ethnic populations that are unrepresented in medical profession
relative to numbers in general population (Association of American Medical Colleges)

7.  NO SURPRISE that the demographic shift in the US population is not reflected in
medical research
 Impact:
 Lack of under-represented minority participants impacts ability to generalize results
 Studies may fail to detect relevant findings in specific groups, due to effects of their
unique mix of environmental, physiologic, and cultural factors
 NIH enforces federal law requiring inclusion of women and minorities in all clinical
research as appropriate for scientific goals
 The FDA currently requires that all investigational new drug and new drug
application studies include demographic information prior to approval
 African Americans, Hispanic individuals, and women are underrepresented in
clinical and randomized controlled trials generally as well as within specific
subspecialties

8.  Charrow et al assessed representation of racial/ethnic minorities and women in
randomized clinical trials (RCTs) - 2010-2015
 626 RCTs across eczema, seborrheic dermatitis, psoriasis, acne, lichen planus,
vitiligo, and alopecia areata
 52 of 626 international (11.3%) studies and 58 of 97 studies (59.8%) conducted
exclusively within the US reported on the racial or ethnic demographics of study
participants
 When race reported in US RCTs, 74.4%of study participants were white
 Disease type significantly associated with degree of racial diversity (P < .001) within a
study cohort:
 30.0%of US-based psoriasis had more than 20%racially or ethnically diverse research participants
as compared with 73.9%of acne studies and 91.7%of eczema studies.
Charrow et al. JAMA Derm
Feb 2017;153(2):193-8

10.  Only one reference reports the likelihood of African American
participation in clinical Dermatology trials
 Examined parents in pediatric dermatology clinic
 Showed disparities existed between White and African American
parents
 White parents slightly more trusting and more knowledgeable about research
than African American parents
 African American parents more inclined to think children would be used as
guinea pigs
 Shadows of Tuskegee Experiments leading to Belmont report and Office for
Human Research Protections
Shaw MG, Morrell DS, Corbie-Smith GM, Goldsmith L. J Nat
Med Assoc. 101.9 (Sep 2009):900-7

11.  Standardized race/ethnicity language for study inclusion to facilitate
tracking specific research data
 Include clearly defined minimum set of demographic data collected
including specific diversity data
 Identify and prioritize dermatologic knowledge and research gaps
for under-represented groups
 When planning racially, culturally, and gender-inclusive studies,
always include methods to disseminate results back to the stake-
holders in question
Desai S, Hernandez C, McMichael A,
JAMA Dermatol 2017;153(2): 132-3

12.  Site commitment and effort important
 Incentives for patients and staff work
 The more community connections, the higher the success
 Sites more successful when sponsors reinforce diversity recruitment
 Internal diversity recruitment reinforcement actions lead to more success
 Staff that can speak the same language as the diverse population helps
 Having culturally competent staff important
 Successful sites over-estimate non-White ethnicities/races and under-estimate
White ethnicity/race populations
Pierre C, Society for Clnical
Research Sites Report, July 2018

13.  Culturally competent care is a patient-centered approach that
includes establishing rapport and engaging in shared decision-
making between the patient and physician in a manner that is
respectful of a patient's values, goals, health needs, and cultural
background
 Training will often be necessary for:
 Awareness
 Attitude
 Knowledge
 Skills
McKesey J et al. Cultural competency for the 21st
century dermatologist practicing in the US. JAAD.
2017;77(6):1159-69.

14. McKesey J et al. Cultural competency for the 21st
century dermatologist practicing in the US. JAAD.
2017;77(6):1159-69.

15.  Train more researchers and residents of diverse backgrounds in Alopecia Areata
 Include diverse students on grants, research projects
 Help them apply to Dermatology residency and MS/PhD programs
 Start with Implicit bias training – many on-line free options
 Diversify your staff
 Get to know your community and let them get to know you
 Work with NAAF to get recruitment info on the website
 Encourage Industry partners to make diversity in studies a priority
 Consider incentives for staff and patients

16. Contact me at:
Amy McMichael, MD
amcmicha@wakehealth.edu