Colin Scott, Forest Research Institute Inc. - Speaker at the marcus evans Evolution Summit, held in Wheeling, IL, April 30 - May 2, 2012 delivered his presentation on the topic Hispanic Patients: An Underrepresented Ethnic Minority in Clinical Research

1. Clinical Trials:
Hispanic P ti i ti
Hi i Participation
A Novel Approach to
pp
Recruitment
Colin Scott, MD
Senior Director – Respiratory
Forest Research Institute

2. Minority Participation in Clinical Research
Why is industry lagging?

3. US 2010 C
Census: 2050 P j ti
Projection
US Demographic Projection
70
60
50
16% 30%
40 2010
%
30 2050
20
10
0
Am rican
Asian
H panic
H anic
can
hite
on-
on-
Afric
ispa
h
no
isp
A
er
o
W
N
Only the Hispanic population shows
significant growth in proportional share

4. Hispanic Initiatives
Hi i I iti ti
Administrative Body Edicts
NIH Revitalization Act, 1993
US Congressional Mandate 2001: clinical trials sufficient to elicit
information of ethnic groups
Office of Management and Budget: Policy Directive
15, 1997
Recommendations for the collection of race and ethnicity data
FDA Guidance for Industry, 2005
Collection of Race and Ethnicity Data in Clinical Trials: differences have
been observed in ethnically distinct subgroups attributable to intrinsic or
extrinsic factors.

5. Forest Clinical Trial Data: 2010
F t Cli i l T i l D t
Demographic Actual v. US Population
100
80
60
4% v. 16%
Forest
%
40 US
Δ 75% Δ 50%
20
0
White
Whit non- Hispanic
Hi i African
Af i Other
Oth
Hispanic American
Non-Hispanic
Trial Participant: middle class, non-Hispanic, white

6. Farma Consulting International
F C lti I t ti l
Bottom-up Approach to
Patient Recruitment
Aim to match
patients to sites www.farmasc.com

7. Targeted Approach to Patients
T t dA h t P ti t
Socioeconomic Profiling
Culture
Language
Location
Economic status
Educational status
Use profile to develop a targeted outreach

8. Touch Points for Outreach
T hP i t f O t h

9. US Hi
Hispanic Population by State
i P l ti b St t

10. Targeted Information Elucidation
T t dI f ti El id ti
Traditional Questionnaire:
structured, open ended, interview
–guided
Nodora J. et al HEALTH 2 (2010)
742-752 Fat Tony says “it gotta be
gaffed”
“Know about clinical trials and
Know
are willing to participate” Targeted Questionnaire:
specific, closed questions,
spontaneous
Communication, Farma
Consulting: data on file 2011
“What’s in it for me?”
“Well, he would, wouldn’t he?”

11. Farma Focus Gro p Results
Foc s Group Res lts
Potential
Potential
Hispanic
Hispanic
Hi i
Patients
Patients
“Trials are
dangerous”
d ”

12. “Clinical T i l
“Cli i l Trials are Dangerous”
D ”
Clinical trials are more closely
regulated than clinical practice
Potential Benefits (per FDA.gov)
• Active involvement in healthcare
• Access to new treatments
• Expert medical care
F. Ross
• Help others by contributing to medical research Johnson
Actual Benefits “BGO”
BGO
• Free intensive healthcare- insurance not needed
• Free drug – (placebo fallacy)
• Extensive diagnostic panel
• Feel better

13. Farma Focus Gro p Results
Foc s Group Res lts
Potential
p
Hispanic
Patients
“Trials are
dangerous”
d ”
“Primary care
= ER”

14. “Primary Care – ER & W lk i ”
“P i C Walk-in”
Dallas Focus Groups (Health fair attendees)
p )
61% reported having a Primary Care Physician
50% used ER or walk-in clinic as their primary care giver
6% used a faith healer
28% haven’t had need of primary care
Threat
h
PCP bad source for clinical trial information
Opportunity
O t it
Reduce the burden of care in ER and walk-in clinics

15. Healthcare Providers:
Underserved Patients
Community clinic in the ‘Barrio’ in San Antonio
Family Pharmacy at medical plaza in San Antonio

16. Farma Focus Gro p Results
Foc s Group Res lts
Potential
p
Hispanic
Patients
“Trials are “COPD? No breathless”
dangerous”
d ”
“Primary care
= ER”

17. “COPD? – N b
No breathless!”
thl !”
¿Fumas o Fumabas? ¿Ti
¿F F b ? ¿Tienes
problemas para respirar? ¿Tienes
40 años o más? Estudio de
investigación clínica p
g para g
gente
con problemas respiratorios.
Podrías recibir compensación.
No se necesita seguro.
Llámanos al
1-866-788-3690
xxx xxxx
KISS Principle

18. Farma Focus Gro p Results
Foc s Group Res lts
“Can’t afford to
Potential get there and
Hispanic what’s i i for
h ’ in it f
Patients me if I do?”
“Trials are “COPD? No breathless”
dangerous”
d ”
“Primary care
= ER”

19. “What’s i
“Wh t’ in it for Me?”
f M ?”
Variable Site Zip Catchment
Zip
Percent Hispanic 48% 91%
Ave. Household $32,952 $20,117
Site Income
Catchment Households 15.4% 36.3%
Below
Poverty
Advanced Degree 51.3% 13.4%
Holders
San Antonio, TX

20. “What’s i
“Wh t’ in it for Me?”
f M ?”
Without patients there will be no clinical trials
Patients should not be Visit costs should be paid to
expected to incur any cost the patients after each visit
attendant on participation
p p as a motivator for retention
in a clinical trial

21. Physician O t
Ph i i Outreach
h
MAHPA Symposium
Hispanic Physicians:
Less involved in drug studies
Less sure about safety
Have less patients asking
about drug studies
Outreach:
Symposia
PI training
Sub-investigator status
Pro-bono benefit of referral

22. Hispanic Participation – Bottom Line
1. Traditional methods not very
successful
2.
2 Outreach has to be targeted
3. Tailor outreach to specific
patient needs
• Reach out at community
level
• Explain benefit
• Pay up-front
We measure success one patient at a time