The concept is at the very core of everything we do: the best health care products are those that help the most people by providing the greatest benefit. Those products should result from clinical trials that include the diverse and representative populations who need them most. It sounds simple, but it’s not. The fact is that while people of diverse ethnic and cultural backgrounds make up nearly 40% of the U.S. population -- and are disproportionally impacted by chronic conditions like diabetes and cardiovascular disease, they are still heavily under-represented in the clinical trials process. Women are likewise under-represented. These gaps exacerbate existing health equity challenges by curbing access to life-changing and life-saving treatments for some, while limiting insights into how different groups respond to new therapies. So we are doing something to close those gaps. Right now. By launching an initiative to drive diversity in research and improve care among under-represented populations, we are working to advance health equity and make access a crucial aspect of product innovation, two key aspects of Abbott's 2030 Sustainability Program. The medical therapies we develop can only be as strong and inclusive as the people who design, develop and participate in our clinical trials. Their involvement will benefit all.

2. Jennifer Jones-McMeans, Ph.D.
Divisional Vice President
Global Clinical Affairs
Abbott’s Vascular Business
SESSION B
Embracing Diversity and
Inclusion in Clinical Trial Design

3. • Learning Objectives
• Diversity and the Clinical Trial Landscape
• Driving Change
• Why Diversity in Clinical Trials Matters
• Promoting Inclusion and Diversity
Agenda

4. Learning Objectives
Explain the importance of diversity and inclusion in clinical trials—making them more
accessible to more people, specifically in underserved communities
Identify ways to better engage diverse communities in clinical trials—making them
more accessible to people
Employ best practices for encouraging diverse participants in clinical trials
Illustrate how clinical trials advance modern medicine but cannot work for all
populations unless all populations participate
Showcase the benefits of delivering long-term impact on clinical trials by designing
clinical trials that more accurately represent the broad spectrum of people

5. Defining Race
“By worldview, I mean a culturally
structured systematic way of looking at,
perceiving, and interpreting various
world realities.
...I define race as such a worldview.”
—Audrey Smedley, Ph.D.
Emerita, Virginia Commonwealth University
Fellow AAAS
Smedley & Smedley, 2012

6. Diverse Populations’ Disease Burden
HYPERTENSION
Non-Hispanic black adults aged 20+
were most likely to have hypertension
in 2015-2016
Notes: Hypertension is measured high
blood pressure (systolic pressure ≥ 140 mm
Hg or diastolic pressure ≥ 90 mm Hg) or
taking medication to lower high blood
pressure. Estimates may differ from others
based on the same data due to different
analytic methodology.
% age adjusted
50%
40%
30%
20%
10%
0%
29.4% 28.7%
42.1%
27.2%
Hispanic White, not
Hispanic
Black, not
Hispanic
Asian, not
Hispanic
OBESITY
Hispanic and non-Hispanic black adults
aged 20+ were most likely to have
obesity in 2015-2016
Notes: Obesity among adults is measured
body mass index (BMI) ≥ 30.0. BMI is
measured weight (kg) divided by measured
height, squared (m2). Estimates may differ
from others based on the same data due to
different analytic methodology.
% age adjusted
50%
40%
30%
20%
10%
0%
46.9%
38.2%
47.5%
12.4%
Hispanic White, not
Hispanic
Black, not
Hispanic
Asian, not
Hispanic
DIABETES
Hispanic and non-Hispanic adults aged
20+ were most likely to have diabetes
in 2015-2016
Notes: Estimates of diabetes prevalence
include both physician-diagnosed and
undiagnosed diabetes. They may differ from
others based on the same data due to
different analytic methodology.
% age adjusted
50%
40%
30%
20%
10%
0%
21.5%
13.0%
19.6%
14.5%
Hispanic White, not
Hispanic
Black, not
Hispanic
Asian, not
Hispanic
HIGH TOTAL
CHOLESTEROL
Hispanic, non-Hispanic white, non-
Hispanic Black, and non-Hispanic Asian
adults aged 20+ were equally likely to
have high total cholesterol in 2015-2016
Notes: High total cholesterol is measured
serum total cholesterol ≥ 240 mg/dL
(6.20 mmol/L). Estimates may differ from
others based on the same data due to
different analytic methodology.
% age adjusted
50%
40%
30%
20%
10%
0%
11.2% 12.6%
10.2% 10.7%
Hispanic White, not
Hispanic
Black, not
Hispanic
Asian, not
Hispanic
NCHS, National Health and Nutrition Examination Survey (NHANES)

7. Economic
Stability
Neighborhood and
Physical Environment
• Employment
• Income
• Expenses
• Debt
• Medical bills
• Support
• Housing
• Transportation
• Safety
• Parks
• Playgrounds
• Walkability
• Zip Code/Geography
Education
• Literacy
• Language
• Early childhood
education
• Vocational training
• Higher education
Food
• Hunger
• Access to healthy
options
Community and
Social Context
• Social integration
• Support system
• Community
engagement
• Discrimination
• Stress
Healthcare
System
• Health coverage
• Provider availability
• Provider linguistic and
cultural competency
• Quality of care
HEALTH OUTCOMES
Mortality, Morbidity, Life Expectancy,
Healthcare Expenditures, Health Status, Functional Limitations
Artiga & Hinton, 2018
Social Determinants of Health

8. The Issue with
Representation in
Clinical Trials
Clinical trials are the foundation of modern
medicine and the ultimate test of effectiveness
and safety before medicines and medical
devices are approved
Women and people of color are systematically
under-represented in clinical trials, thus impacting
the overall outcome, effectiveness, and safety of
new innovations and breakthrough therapies on
broad patient populations
Yates et al, 2020

9. Clinical Trials Not Representative
of U.S. Population
Hispanic
16%
African
American
12%
Caucasian/
Other 72%
U . S .
P O P U L A T I O N
Society for Women’s Health Research and United States Food and Drug Administration Office of Women’s Health, 2011
Hispanic
1% African
American
5%
Caucasian/
Other 94%
C L I N I C A L T R I A L
P A R T I C I P A N T S

10. • In 2020, Center for Drug Evaluation and Research approved
53 novel drugs, either as:
– New molecular entities (NMEs) under new drug applications (NDAs) or
– New therapeutic biologics under biologics license applications (BLAs)
• Overall, 32K patients participated in these trials
• Selected subpopulation demographics from these trials
are presented
Food and Drug Administration (FDA)
Drug Trial Snapshot Report
Women, 56%
Men,
44%
Sex
White
75%
Black or
African
American
8%
Asian
6%
Other
11%
Race
USA, 75%
Outside
USA, 25%
Geography
Non-Hispanic or
Unknown, 89%
Hispanic,
11%
Ethnicity
<65, 70%
≥65, 30%
Age
Percent Participation in Clinical Trials by Subpopulation* for Molecular Entities and Therapeutic Biologics Approved in 2020
⃰ The percentage of all other races combined (American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, Other, Unknown/Unreported) makes up to 100% of race category.
⃰ The percentage of Non-Hispanic and Unknown/Unreported ethnicity makes up to 100% of ethnicity category.
⃰ The percentage of patients from anywhere else in the world makes up to 100% of geographic category.
United States Food and
Drug Administration, 2021
2020 Summary Statistics (January 1, 2020–December 31, 2020)

11. A New Approach to
Diversity in Clinical Trials

12. By 2030, we intend to improve the lives of more than three billion people—
one in every three people on the planet.
That’s over one billion more people than we currently impact.
Advance
health equity
through partnership
Transform care for
chronic disease,
malnutrition, and
infectious diseases
Make access and
affordability core to
new product innovation
AB B O T T ’ S G O AL
A Sustainable Future Starts with Health

13. Making a Difference Today
Removing
Barriers For
Patient Access
Diversity
Advisory Board
Cross-industry
Collaboration
Investigator
Selection
Diversity
Site Selection
Diversity
Mentoring
Collaborating with
investigators
representative of
the people
they serve
Rectifying the
representative of
trial participants by
adding a focus on
diversity of
enrollment at
investigative sites
Providing experts
and advising to
mentor new
investigators
Working proactively
to understand and
remove barriers to
patient access to
clinical trials
Partnering with
organizations like
AdvaMed and
regulators to
facilitate change
Providing counsel
on ways to reduce
barriers to
access among
underrepresented
communities, so
that they become
more inclusive
across the industry

14. Mentor physicians new
to research
Lack of trust and comfort
in process
Build community trust through
community focused physicians
Investigator, Site Selection, and Mentoring
0.3% 5.0%
1.0%
0.8%
56.2%
17.1%
5.8%
0.1%
13.7%
% of All Active Physicians by Race/Ethnicity in 2018
American Indian or Alaska Native (2,570)
Black or African American (45,534)
Multiple Race, Non-Hispanic (8,932)
Other (7,571)
White (516,304)
Asian (157,025)
Hispanic (53,526)
Native Hawaiian or Other Pacific Islander (941)
Unknown (126,144)
Note: Shows the percentage of active physicians by race and ethnicity as of July 1, 2019
Source: Race and ethnicity are obtained from a variety of sources including DBS, ERAS, APP, MCAT, SMDEP,
GQ, MSQ, PMQ, FACULTY, GME, STUDENT with priority given to the most recent self-reported source.
Clark et al. (2019)
Social Determinants of Health: Poor Diversity of Physicians

15. Diversity in the sites selected for clinical trials leads to diversity in
the patients enrolled; and therefore, more applicable data outcomes
Dr. Lyssa Ochoa, vascular surgeon
at the SAVE Clinic in San Antonio,
Texas, noticed discrepancies in
the health outcomes of
her patient population.
Abbott recruited Dr. Ochoa to
participate in the LIFE-BTK
trial in hopes of addressing
the disparities.
SAVE Clinic was a “non-traditional”
site and new to the clinical trial
process but had access to the
patients with the greatest
need for treatment.
Today, with Abbott’s support,
the SAVE Clinic has access to
resources and is developing clinical
research skills that will ultimately
benefit the patients it serves.
New Model Realized: LIFE-BTK
Changing the Clinical Trial Ecosystem

16. TRANSPORTATION
SUPPORT
LODGING
& MEALS
HOME
VISITS
PATIENT
WEBSITE
TRANSLATION
SERVICES
PATIENT VIDEO &
RADIO MEDIA TOUR
Removing Barriers for Patient Access

17. Food and Drug Administration guidance to
promote enrollment practices to lead to
clinical trials that best reflect the population
that will use the treatment if approved
• Broadening eligibility criteria
• Inclusive trial practices
• Trial designs that support broader enrollment
• Reduce burden in trial enrollment
• Enrollment retention practices
Cross-Industry
Collaboration

18. Long-Term Vision
• Physicians are more reflective of U.S. and
global population
• Diverse patients in clinical trials to mirror the
diversity of those burdened with the disease
• Therapeutics that have demonstrated
efficacy for all populations
Diversity Advisory
Board

19. Care for all patients
Treat the patient
population adversely
impacted
Product data across
groups of people
The right thing to do
Diversity in
Clinical Trials
Integration of Health Equity

20. Engagement with a
broader population
Improved next-gen
healthcare
Clinical evidence inclusive
of underserved populations
Clinical Trials Diversity Results

21. OFFER
trial sites resources
to support the
development of
diversity action plans
SEEK OUT
opportunities to expand
the reach of trials via
identification and
mentoring new sites
DISCUSS
diversity with trial
sites for awareness
and action
ENCOURAGE
diverse patient
enrollment conversations
Key Learnings and Recommendations
Accelerating Clinical Trial Inclusion and Diversity

22. Built as if it was
intended for my family.

23. • Artiga, S. & Hinton, E. (2018, May 10). Beyond Health Care: The Role of Social Determinants in Promoting Health and Health Equity. Kaiser Family Foundation.
https://www.kff.org/racial-equity-and-health-policy/issue-brief/beyond-health-care-the-role-of-social-determinants-in-promoting-health-and-health-equity/
• Clark, L. T., Watkins, L., Pina, I. L., Elmer, M., Akinboboye, O., Gorham, M., Jamerson, B., McCullough, C., Pierre, C., Polis, A. B., Puckrein, G. & Regnante,
J. M. (2019, May). Increasing diversity in clinical trials: Overcoming critical barriers. Current Problems in Cardiology, 44(5), 148-172.
https://doi.org/10.1016/j.cpcardiol.2018.11.002
• Smedley, A. & Smedley, B. (2012). In Race in North America: Origin and Evolution of a Worldview (4th ed.). Taylor & Francis.
• Society for Women’s Health Research and United States Food and Drug Administration Office of Women’s Health. (2011). Dialogues on Diversifying Clinical
Trials. https://www.fda.gov/media/84982/download
• U.S. Food & Drug Administration. (2021, February). 2020 Drug Trials Snapshots Summary Report.
https://www.fda.gov/media/145718/download?utm_medium=email&utm_source=transaction
• Yates, I., Byrne, J., Donahue, S., McCarty, L., & Mathews, A. (2020, August). Representation in clinical trials: A review on reaching underrepresented populations
in research. Clinical Researcher, 34(7). https://acrpnet.org/2020/08/10/representation-in-clinical-trials-a-review-on-reaching-underrepresented-populations-in-
research/
References

24. Jennifer Jones-McMeans, Ph.D.
Divisional Vice President
Global Clinical Affairs
Abbott’s Vascular Business
jennifer.jones@abbott.com
Questions & Answers

25. Jennifer Jones-McMeans, Ph.D.
Divisional Vice President
Global Clinical Affairs
Abbott’s Vascular Business
jennifer.jones@abbott.com
Thank You