hispanic patients: an underrepresented ethnic minority in clinical research - colin scott, forest...
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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 ResearchTRANSCRIPT
Clinical Trials: Hi i P ti i tiHispanic Participation
A Novel Approach to ppRecruitment
Colin Scott, MDSenior Director RespiratorySenior Director – RespiratoryForest Research Institute
Minority Participation in Clinical Research
Why is industry lagging?
US 2010 C 2050 P j tiUS 2010 Census: 2050 ProjectionUS Demographic ProjectionUS Demographic Projection
6070
16% 30%
20304050
%20102050
16% 30%
01020
hite
on-
pani
c
anic
can
rican
on-
Asi
an
Wh no
His
p
His
pa
Afri
c
Am
er No A
Only the Hispanic population shows Only the Hispanic population shows significant growth in proportional share
Hi i I iti tiHispanic Initiatives
Administrative Body EdictsAdministrative Body Edicts
NIH Revitalization Act, 1993US Congressional Mandate 2001: clinical trials sufficient to elicit US Congressional Mandate 2001: clinical trials sufficient to elicit information of ethnic groups
Office of Management and Budget: Policy Directive 15, 199715, 1997
Recommendations for the collection of race and ethnicity data
FDA Guidance for Industry, 2005Collection of Race and Ethnicity Data in Clinical Trials: differences have Collection of Race and Ethnicity Data in Clinical Trials: differences have been observed in ethnically distinct subgroups attributable to intrinsic or extrinsic factors.
F t Cli i l T i l D t 2010Forest Clinical Trial Data: 2010
Demographic Actual v. US Population
100
40
60
80
%
ForestUS
4% v. 16%
0
20
40
Whit Hi i Af i Oth
USΔ 75% Δ 50%
White non-Hispanic
Hispanic AfricanAmerican
Non-Hispanic
Other
Trial Participant: middle class, non-Hispanic, white
F C lti I t ti lFarma Consulting International
Bottom-up Approach to Patient RecruitmentPatient Recruitment
Aim to match Aim to match patients to sites www.farmasc.com
T t d A h t P ti tTargeted Approach to Patients
Socioeconomic Profiling
CultureLanguageLanguageLocationEconomic statusEconomic statusEducational status
Use profile to develop a targeted outreach
T h P i t f O t hTouch Points for Outreach
US Hi i P l ti b St tUS Hispanic Population by State
T t d I f ti El id tiTargeted Information Elucidation
Traditional Questionnaire: structured, open ended, interview –guided
Nodora J. et al HEALTH 2 (2010) 742-752
“Know about clinical trials and
Fat Tony says “it gotta be gaffed”
Know about clinical trials and 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?”
Farma Foc s Gro p Res ltsFarma Focus Group Results
Potential Hispanic Potential Hi i Hispanic PatientsHispanic Patients
“Trials are d ”dangerous”
“Cli i l T i l D ”“Clinical Trials are Dangerous”Clinical trials are more closely Clinical trials are more closely regulated than clinical practicePotential Benefits (per FDA.gov)
• Active involvement in healthcare
• Access to new treatments
F. Ross Johnson
“BGO”
• Expert medical care
• Help others by contributing to medical research
Actual Benefits BGOActual Benefits
• Free intensive healthcare- insurance not needed
• Free drug – (placebo fallacy)
• Extensive diagnostic panel
• Feel better
Farma Foc s Gro p Res ltsFarma Focus Group Results
Potential Hispanic pPatients
“Trials are d ”dangerous”
“Primary care “Primary care
= ER”
“P i C ER & W lk i ”“Primary Care – ER & 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
hThreatPCP bad source for clinical trial information
O t itOpportunityReduce the burden of care in ER and walk-in clinics
Healthcare Providers: Underserved Patients
Community clinic in the ‘Barrio’ in San Antonio
Family Pharmacy at medical plaza in San Antonio
Farma Foc s Gro p Res ltsFarma Focus Group Results
Potential Hispanic pPatients
“Trials are d ”
“COPD? No breathless”dangerous”
“Primary care “Primary care
= ER”
“COPD? N b thl !”“COPD? – No breathless!”
¿F F b ? ¿Ti¿Fumas o Fumabas? ¿Tienesproblemas para respirar? ¿Tienes
40 años o más? Estudio de investigación clínica para gente g p g
con problemas respiratorios. Podrías recibir compensación.
No se necesita seguro. Llámanos al Llámanos al
1-866-788-3690 xxx xxxx
KISS Principle
Farma Foc s Gro p Res ltsFarma Focus Group Results
Potential Hispanic
“Can’t afford to get there and h ’ i i fHispanic
Patientswhat’s in it for
me if I do?”
“Trials are d ”
“COPD? No breathless”dangerous”
“Primary care “Primary care
= ER”
“Wh t’ i it f M ?”“What’s in it for Me?”Variable Site Zip CatchmentVariable Site Zip Catchment
Zip
Percent Hispanic 48% 91%
SiteAve. Household
Income$32,952 $20,117
Catchment Households Below Poverty
15.4% 36.3%
Poverty
Advanced Degree Holders
51.3% 13.4%
San Antonio, TX
“Wh t’ i it f M ?”“What’s in it for Me?”
Without patients there will be no clinical trials
Patients should not be expected to incur any cost attendant on participation
Visit costs should be paid to the patients after each visit as a motivator for retentionp p
in a clinical trialas a motivator for retention
Ph i i O t hPhysician OutreachMAHPA Symposium
Hispanic Physicians:Less involved in drug studies
MAHPA Symposium
Less sure about safety
Have less patients asking about drug studies
Outreach:Symposia
PI training
Sub-investigator status
Pro-bono benefit of referral
Hispanic Participation – Bottom Line
1. Traditional methods not very successful
2 Outreach has to be targeted2. Outreach has to be targeted
3. Tailor outreach to specific patient needs
• Reach out at community level
• Explain benefit• Explain benefit
• Pay up-front
We measure success one patient at a time