Transcript Slide 1

The Whats, Whys and Hows
of Hispanics & Latinos’
involvement in Clinical Research
Sara Tylosky
MMG
CONFIDENTIAL
MMG
A global full-service patient recruitment and
retention group that develops strategies to
accelerate patient enrollment, achieve participant
retention goals in clinical research
CONFIDENTIAL
Objectives:
A real story
of a Latina
being in
clinical
research
Why are
Hispanics/Lati
nos not
involved in
clinical
research
How a
HispanicLatino
physician get
involved in
clinical
research
What do
we know about
Hispanics/Latinos
and their
involvement in
clinical research
CONFIDENTIAL
Objectives:
What do
we know about
Hispanics/Latinos
and their involvement
in clinical research
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Background on Hispanics &
Latinos in the U.S.
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Hispanics/Latinos
are the dominant force in the U.S.1
• 16 percent of the U.S. population
• Americans of this descent - 2nd largest
population group
• Youngest demographic group, with a
median age of 27.4 years versus 36.8
years in the general population
• The United States has 2nd largest
Hispanic/Latino population worldwide
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1. Census 2010
Hispanics & Latinos are expected to
grow to 30 % by 20501
2010 – 16% of the population
2020 – 18% of the population
2050 – 30% of the population
Hispanic Population in U.S.
35%
30%
25%
20%
15%
10%
5%
0%
2010
2020
2050
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1. U.S. Census 2010
2000-2020 Hispanic/Latino 2nd
Generation Dominates Growth2
•Change in Hispanic Population 2000-2020:
•35.3 million to 60.4 million
140
120
100
80
60
40
119
100
71
63
47
45
25
28
Growth
20
0
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2. Pew Hispanic Center
Geography of Hispanics & Latinos:
• California & Texas: 47% have of the
Hispanic-origin population with 13.7 million
9.1 million Hispanics respectively1
• These two states are KEY geographies for
Hispanic & Latino recruitment success.
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1. U.S. Census 2010
Geography of Hispanics & Latinos:1
• 16 states with at least ½ -million Hispanic residents.
• 46 % of New Mexico's population in 2009 was Hispanic, the
highest of any state.
• Between 2008 & 2009, a 6.6 % increase in the Hispanic
population in Alabama (highest increase).
• These states represent another layer of geographic
opportunity to target Hispanic & Latino recruitment.
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1. U.S. Census 2010
Economic Challenges for Hispanics & Latinos
1 in 4 U.S. Hispanics lives in poverty, and 1 in
5 under 18 years of age live in poverty. 1
Many Hispanics hold down >1 job. It is
difficult for them to make the necessary
appointments for clinical trial for fear of losing
their job.
The most vulnerable age groups: U.S.
Hispanic children & elderly, of whom 33.1 %
& 18.3% live below the poverty line
respectively.1
Caring for children and the elderly is culturally
important for Hispanics & Latinos; therefore,
engaging in a trial presents another time
challenge to participate in a trial.
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1. U.S. Census 2010
Yet, Hispanics/Latinos are
Underrepresented in U.S. Clinical Trials
Relative to their Population
• 1995-1999: only 3% of clinical trial participants were
Hispanic or Latinos3
• 1996-2002: 3.1% of clinical trail participants for breast,
lung, colorectal, and prostate cancers were Hispanic or
Latino4
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3. Evelyn, 2001
4.Gonzalez et al 2010
Hispanics/Latinos are
Underrepresented in U.S. Clinical Trials
Relative to their Population
• From 2003-2005, overall Hispanic/Latino participation of the
National Cancer Institute funded cancer clinical trial was 5.6% 5
• As of 2009, minorities participating in clinical trials have
remained lower than Caucasian participation relative to their
demographics6
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5. iccnetwork.org 2010
6. Barreau 2010
Even in a disease – COPD, where
there is under treatment of Hispanics/Latinos
• Hispanics /Latinos have lower prevalence &
death rates for both chronic bronchitis and
emphysema compared to Caucasians7
• YET, access to quality healthcare & lack of
proper diagnosis remains a huge obstacle
for Hispanics who suffer from COPD. 8
• A study of COPD patients found that Hispanics
visited the emergency room at twice the rate
of Caucasian patients.8
• This suggests that even though fewer Hispanics
suffer from COPD, low access to healthcare
may prevent them from receiving the routine
treatment they need to control their COPD8
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www.farmasc.com
7. Centers for Disease
8.Chui-Lin et al, June, 2007
Even in a disease – COPD,
where there is under treatment of
Hispanics/Latinos
• Mexican American elders have similar
severities of COPD despite less tobacco
exposure than European American elders
and Mexican Americans represent 67% of
the Hispanics & Latinos population9
• Hispanic patients with COPD have more
problems receiving optimal care
compared to patients of other racial
groups10
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www.farmasc.com
9. Respiratory Medicine,
2006
10. Chest, 2003
What does this all mean?
Industry is behind
representing
Hispanics/Latinos in trials
Physicians are asking for
more data around
Hispanics & Latinos to
feel more comfortable to
Rx
FDA encourages
sponsors to collect the
data in accordance with
OMB for race and ethnicity
categories when
developing their study
protocols11
Hispanics & Latinos need
more appropriate health
options
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11. hhs.gov/oirm/infocollect/nclusion.html
Objectives:
A real story of
a Latina being
in clinical
research
What do we know
about
Hispanics/Latinos
and their involvement
in clinical research
CONFIDENTIAL
The real story of Gabriela,
one Hispanic/Latina12
• Gabriela, a 45 year old Latina, developed HIV from her husband from
an extramarital relationship in 1994
• Through her husband, she also passed on HIV on to her daughter.
• Both Gabriela’s husband and daughter died within a two years of
confirmation from HIV complications
• The next 2 years, Gabriela suffered from:
– anger,
– depression,
– frustration,
– confusion & sense of helplessness,
– and her health suffered.
• She decided to give up her other 2 children for adoption as she felt
incapable of taking care of them
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12. Interview 2010
The real story of Gabriela,
one Hispanic/Latina12
•
•
•
•
•
Eventually Gabriela ended up in the E.R. due to complications of:
– tuberculosis, pneumonia, herpes, mouth infection and
eventually Hepatitis C and Parkinson’s
After 5 years of psychological therapy and joining a support group, she
joined a trial in 2000 & has been in studies (via NIH) ever since.
15 years later, Gabriela is now the spokesperson to help other Latinas
seek options to better understand their medical condition and
circumstances by learning about themselves, their health and clinical
trials, called LUNA
Her one son is back living with her, taking care of her
Since most studies have been with “Americanos blancos,”
she hopes we can have more Hispanics & Latinos in trials
to see how they respond differently to medications
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12. Interview 2010
Objectives:
Why are HispanicLatinos not involved
in clinical research
A real
story of a
Latina
being in
What do we
know about clinical
Hispanics/Lati research
nos and their
involvement in
clinical
research
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Todos Juntos por la Salud Forum
February 2011 Preview of findings
around WHY low research participation
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Key issues as to lack of
Hispanic-Latino participation in trials13
• Lack of awareness
• Lack of a clear message
– Benefits of clinical research
– Bring stakeholders together
– Identify target for message
• Mistrust & misconceptions
– Stigma of certain diseases
– “White” and/or not culturally
competent staff
– Language & culture
– Lack of relationships
–
–
–
–
–
Patient level
Physician level
Community level
Access to research
Access to funding
• Lack of training
–
–
–
–
Principal Investigator training
HCPs
Nurses
Community
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13. Findings, MMG
Phase I – Develop the story about
clinical research13
•
•
•
Define the story: what is clinical research in the U.S. (Phase 1-IV) & what does
that mean for an individual patient and/or family member in lay terms
Discuss Stigmas
– Use real people via media to share stories and successes about
research
– Create access tools like CBO ambassadors, online media to
disseminate to communities to breakdown barriers of specific
diseases, e.g., mental disorders, HIV, HCV, etc.
– Tools like CISCRP and other CBOs that deal in certain diseases (AHA,
ACS, etc.)
Share benefits of being in clinical research
– How research helps future generations to come
– Can provide treatment options to disease or condition
– Be in Support groups that exist around disease (e.g., LUNA, PACT)
– Risk/benefit, payment for volunteer participation in trial, etc.
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13. Findings, MMG
Phase II – Identify groups to
share story and educate13
• Identify Stakeholders
–
–
–
–
–
–
–
–
–
Pharmas/Biotechs
PIs, HCPs, Nursing staff, CBOs, patient groups
Key Hispanic/Latino Health Advocacy groups
Hospital associations, Community centers, “hotspots” of care, safety
nets, waiting rooms = educational centers
Nursing groups
People that touch research
Corporations interested in Hispanic/Latino Health (e.g., Walmart
pharmacies, etc.)
Other CBOs (Community Based Organizations)
Patient groups
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13. Findings, MMG
Phase III – Educate & Train
•
•
•
Develop relationships between healthcare and patient community
– Create partnerships between Pharma industry, “hotspot” healthcare
communities and CBOS
– Fund through Pharmas/Biotechs Large Healthcare research advocacy
groups interested in tapping into Hispanic/Latino market (e.g., AHA,
ACS, etc.)
Create educational venues at all levels create better awareness
– Forums & campaigns like Todos Juntos broken down into
groups/regions, etc.
– P.I. training for Hispanic/Latino HCP
– Training at Hispanic/Latino nursing groups
Include cultural competency training
– Includes relationship building, spiritual awareness, gender issues,
language
– Simple language for patient
– Includes overview of the subtle differences between sub groups
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13. Findings, MMG
Phase IV –
Bring the resources together13
• Develop feedback database where learning has
occurred
• Monitor the media to update trainings/findings
• Create new relationships between healthcare and
patient community for research opportunities
• Develop tangible research projects based on new
medications coming into the marketplace
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13. Findings, MMG
Example of Language & Cultural
Competency of Hispanics & Latinos14
• Differences: A grandmother
from Puerto Rico in New York
City vs. single Mexican man
living in rural Texas vs. a 2ndgeneration Cuban student living
in Miami.
YES
SI
• Beyond Spanish. 55% of
Hispanics have Spanish as
dominant language. 21%
speak English most of the
time and 13% speak only
English.
OUI
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14. Rayo, 2010
Example of Language & Cultural
Competency of Hispanics & Latinos14
• Focus on the cultural connections.
Connect with their cultural traditionsroots in the family or in food.
• Give them something to do. 73% of
Hispanics & Latinos more likely to
engage when equipped to become
active.
• Remember that a little goes a long
way. Create a message with 1-2
seconds of a Spanish-language
which can resonate such as the VW
ads recently viewed on TV.
www.farmasc.com
14. Rayo, 2010
Hispanic oriented
VW cc ad filmed in Mexico 2008
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15. www.youtube.com/watch?v=K-0FHgMuOi0
Objectives:
A real story of
being in
clinical
research
Why are
HispanicLatinos not
involved in
clinical
research
What do we know
about
Hispanics/Latinos
and their
involvement in
clinical research
CONFIDENTIAL
How a HispanicLatino physician
get involved in
clinical research
How to become a Principal
Investigator as a community based physician
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What six key steps do you
need to take?
1.
2.
3.
4.
5.
6.
Know the regulations
Have your site inspected
Get IRB approval
Sign a Contract
Prepare for a site Initial Visit
Build your network
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1. Know the regulations-Good
Clinical Practices (GCP)16
•
GCP
– International ethical and scientific quality standard for
the design, conduct, recording and reporting of clinical
trials that involve the participation of human subjects
–
Compliance with this standard provides public
assurance that the rights, safety and wellbeing of trial
subjects are protected, consistent with the principles
that have their origin in the Declaration of Helsinki, and
that the clinical trial data and reported results of
clinical investigations are credible and accurate
– GCP training available through many online sources
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16. ClinicalTrials.com 2010
1. Know the regulations –
Key Federal Codes16
•
Regulations which define what is required by
the US FDA and covers the responsibilities of
sponsors, investigators, and Institutional
Review Board (IRB)
– 21 Code of Federal Regulation (CFR)
Part 50 Protection of Human Subjects
– 21 CFR Part 54 – Financial Disclosure
by Clinical Investigators
– 21 CFR Part 56 – Institutional Review
Boards (IRBs
– 21 CFR Part 312 – Investigational New
Drug Application
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16. ClinicalTrials.com 2010
2. Have your site inspected16
•
A clinical research associate (CRA) who represents
the sponsor will conduct a pre-study site visit at your
site to evaluate your experience, expertise and interest
as well as your staff, facility and potential patient
population available for the clinical trial.
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16. ClinicalTrials.com 2010
3. Get IRB approval16
•
Get IRB approval. An institutional review
board (IRB) is a group designated to
protect the rights, safety and well-being of
patients involved in a clinical trial by
reviewing all aspects of the trial and
approving its startup. You will be required
to obtain IRB approval for the study at
your site.
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16. ClinicalTrials.com 2010
4. Sign a Contract16
•
A contract between you and the sponsor or a CRO needs
to be signed before the clinical trial starts. The document
usually contains your responsibilities, including the
number of subjects you are expected to enroll, timelines
for enrollment and the regulatory requirements. It also
includes the sponsor’s responsibilities, including financial
compensation and how it will be paid. Most sponsors
follow a fee-for-service model, meaning they pay for
actual work performed, such as subjects enrolled and
subject visits
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16. ClinicalTrials.com 2010
5. Prepare for a site Initial Visit16
•
A CRA will conduct a site initiation visit
(SIV) after the IRB has given its approval
and the contract and all essential
documents have been completed. The
purpose of this visit is to assure that
everything is in place for you to begin
enrolling patients.
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16. ClinicalTrials.com 2010
6. Build your knowledge network17
•
•
•
•
•
Cultural competency training
www.CenterWatch.com and www.Clinicaltrials.gov are two
websites that list thousands of trials to get connected
Check out websites of other pharma/biotech companies within a
certain disease
MyClin is a unique online communication, information and
management tool for all participants in FDA regulated trials
www.myclin.com
Build relationships through conferences, forums, summits like
this and others
CONFIDENTIAL
17. CenterWatch.com, Clinicaltrials.gov, myclin.com
Summary points:
Hispanics & Latinos
are a growing
population and
major force in the
U.S. market
Hispanics & Latinos
have unmet medical
needs and represent
a key component in
clinical trials
There are unique
barriers that limit their
participation in clinical
trials
Appropriate outreach
will increase
Hispanic/Latino
participation into trials
MMG can help
implement such a
program
CONFIDENTIAL
QUESTIONS & COMMENTS?
Thank you for your time
Gracias por su tiempo
Sara Tylosky
John Benbrook
[email protected]
Tel: 561-744-9304
[email protected]
Tel: 240-747-1719
CONFIDENTIAL