Eliminating Barriers to Minority
Participation in Clinical Trials
Debra Wujcik, RN, PhD
Director Clinical Trials at Meharry
Assistant Professor of Nursing
History of Mistrust
Background
• Approximately 20% of adult cancer patients are
medically eligible for a cancer clinical trial.
• Less than 3% of adult cancer patients
participate in a cancer clinical trials.
– Accrual is even less for minority and medically
underserved populations.
• Studies show minority groups are as willing to
participate as whites, but are less likely to be
invited to participate.
• Those who participate in clinical trials are more
likely to be insured and have higher
socioeconomic status.
Presentation Outline
• Cancer Clinical Trials Unit at Nashville
General Hospital at Meharry
• ENACCT Community Partners Project
Program Development
• 1998
– Nashville General Hospital
moved to Meharry Medical
College Campus
• 2000
– Research team formed at
MMC under U54
Partnership grant
• 2003
– Minority Based Community
Clinical Oncology Program
Grant (MBCCOP)
Assumptions
• Vanderbilt studies would be opened at
NGH and accrual would begin.
• Minority and underserved persons don’t
want to participate in research.
Identification of Barriers to Care
and Clinical Trial Participation
• Missed appointments.
– How does the patient enter the system?
– Who makes the appointments?
– Who reminds the patient?
• Missed communication.
– How does the physician know the pathology results?
– How does the patient find out?
• Missed rides.
– Does the patient have transportation?
– How reliable is the transportation?
Identification of Barriers (cont.)
• Lack of insurance.
– Most patients present with no insurance
• Indigent
• Self pay on sliding scale and/or with discounts
• TN Care
• Lack of understanding.
– Assess what the patient knows/understands.
– Who influences patient? What do they
know/understand?
Procedure for Screening
• All patients diagnosed at MMC are evaluated for
study eligibility.
– Cancer committee requested all patients with cancer
be evaluated.
• Pathology reports are sent to research staff.
• Cases are identified and “managed” by the
research team.
– Team reports progress through the system and
arranges appointments and referrals as needed for
diagnostic work up and staging.
Clinical Trial Accrual Rates
2001-2004
Year
Screened
Study
Available
Placed
on study
Total
Accrual
Rate
Actual Accrual
Rate
1
154
32
15
10%
47%
2
108
38
17
16%
45%
3
145
44
27
19%
43%
4
162
50
36
22%
44%
Reasons patients did not go on
study (2001-2004)
•
•
•
•
•
•
•
•
•
•
•
Co-morbidity
Eligibility
Performance status
Refused treatment
Dept of corrections
Refused research
Refused specific trial
Returned to local MD
Insurance
Lost to follow up
Transportation
19
17
12
8
5
3
3
2
1
1
1
72
27%
23%
17%
11%
7%
4%
4%
3%
1%
1%
1%
Cases are identified and managed
by the research team
•
•
•
Every patient is identified and
screened.
– Pathology reports are
reviewed.
– Abnormal screening results
are reviewed.
Information is entered into a
database for review at weekly
research team meeting.
Patients are navigated through
the system using:
– Nurse navigator
– Research nurse
Model of Care Refined
• Every patient is identified and screened.
–
–
Pathology reports are reviewed.
Abnormal screening results are reviewed.
• Information is entered into a database for
review at weekly research team meeting.
• Patients are navigated through the system
using:
–
–
Nurse navigator
Research nurse
Model of Care Refined (cont.)
• Physician is advised if a clinical trial
available.
– A plan to address obstacles such as
transportation or medications is developed.
• Clinical trial option is offered during initial
treatment discussion.
– Clinical trial is not an afterthought.
– Patient is not referred elsewhere for clinical
trial participation.
Screened Patients
Racial/Ethnic Distribution of Screened Patients
0%
1%
8%
Black
46%
White
Hispanic
Asian
45%
Alaskan
Screened Patients
Insurance Distribution of Screened Patients
18%
38%
4%
Uninsured
Indigent
TN Care
8%
Medicare
Commercial
TDOC
16%
16%
Screened Patients
Gender Distribution of Screened Patients
36%
Male
Female
64%
All Patients on Study 2005-2008
Racial/Ethnicity Distribution in Cancer Trials
120%
100%
Hispanic
80%
Pac Islander
60%
White
40%
Black
20%
0%
2005
2006
2007
2008
All Patients on Study 2005-2008
Gender Distribution in Cancer Trials
120%
100%
80%
Female
60%
Male
40%
20%
0%
2005
2006
2007
2008
Clinical Trial Accrual Rates
Year
Screened
Study
Available
Placed
on study
Total
Accrual
Rate
Actual Accrual
Rate
1
154
32
15
10%
47%
2
108
38
17
16%
45%
3
145
44
27
19%
43%
4
162
50
36
22%
44%
5
138
29
19
14%
66%
6
184
59
53
29%
90%
7
234
91
66
28%
73%
21%
68%
Ave
Outcome of Screened Patients
2005-2007
Study available, pt. eligible
33%
On study
30.0%
Refused research
2.5%
Treat off study
0.5%
Study available, pt not eligible
5%
Treat off study
4.5%
No treatment offered
0.5%
Study not applicable
8%
Treat off study
7.0%
No treatment offered
1.0%
Study not available
50%
Treat off study
46.5%
No treatment offered
Refused Treatment
3.5%
3%
Wujcik, D & Wolff, SN. (2010).
Recruitment of African
Americans to national oncology
clinical trials through a clinical
trials shared resource. Journal
of Health Care for the Poor and
Underserved, 21: 37-52.
Summary
• Racial/ethnic minority and underinsured
patients are willing to participate in cancer
clinical trials.
• A team approach and case management
(navigation) strategies ensure success.
• A proactive rather than reactive approach
is needed.
ENACCT Implementation
Partners Project
Education Network to Advance
Cancer Clinical Trials
• The only national organization solely devoted to
community-centered approaches to cancer
clinical trials education.
• Dedicated to finding evidence based approaches
that work to change attitudes, behaviors and
ultimately, accrual.
• http://www.enacct.org/
25
Goals of Implementation
Partners Project
• To increase knowledge and improve attitudes
about clinical trials among minority and
underserved populations in Nashville, TN.
• To identify community concerns and
opportunities regarding clinical trials participation
and make recommendations for future
collaborations and interventions.
• To identify community members interested in
participating in ongoing initiatives.
Objectives
• Engage participants in discussion to identify
common concerns and opportunities
– Host six town hall meetings with guided discussion
format
– Show participants informational DVD.
• Identify at least 6 community members
interested in participating in ongoing initiatives
such as advisory board members, IRB
members, or community advocates
Organizational Partners
• Vanderbilt Ingram Cancer Center
• Meharry-Vanderbilt-Tennessee State
University Cancer Research Partnership
• Clinical Trials Shared Resources
– VICC CTSR
– MMC/VICC Partnership CTSR
• Tennessee Comprehensive Cancer
Control Coalition – Middle TN Region
Community Partners
• Nashville Branch of the NAACP Health
Committee
• Cervical Cancer Coalition of Tennessee
• Nashville Health Disparities Coalition
• Nashville Latino Health Coalition
• Super 60s of NGH
• Dickson Community Health Council
Town Hall Meetings
• Sponsored by community
partner
• Target 20 participants
• Agenda
– Welcome and snacks
– Educational DVD and
print materials
– Focused discussion,
recorded for later
transcription
– Medical hero
• Babysitting provided as
needed
• Participants receive $25
gift card
Demographic Data
•
•
•
Attendance
– Participants
– F/U Volunteers
Gender
– Male
– Female
Education
– Less than HS
– Some HS
– HS Graduate
– College
96
49
•
•
23
75
•
3
6
33
39
Average age
49
Race
– White, Non Hispanic 7
– White, Hispanic
11
– Black
76
– Other
2
Research Exp
– Yes
32
• Positive
23
• Negative
0
• Neutral
3
– No
64
In their own words….
• What is your experience with cancer
– “It’s just amazing how fast it kills”
– “I wanted to come today to say that I want to
be a part of whatever I can to stop families
from going through that”
– “Men need to be teaching their families”
In their own words….
• When you hear the word cancer, what
comes to mind?
– “The first thought that comes to mind is fight”
– “I think about the connection between healing
and spirituality”
– “What comes to mind is what type, what
stage, and what can be done because I know
there’s hope”
In their own words….
• What comes to mind when you hear the
word research?
– “We definitely need to get African American
people involved”
– “First thing I do is question the validity and
then I question me doing it, and then I want to
see somebody that looks like me doing it”
– “…we still need to be careful about who’s
doing the research”
In their own words….
• When you hear the word research….
– “When we talk about the research, you can go back to
Tuskegee and you have to remember, okay, the
same people who we’re being asked to trust with our
lives now, in research projects, are the same people
who, you know, did this in Tuskegee”
– “Once you figure out a treatment, am I going to be
able to afford it? Is it going to be available to me? Is it
going to be available to people like me?
In their own words….
• What would motivate you to participate?
– “Letting people know that we are furthering progress
in treating something by the research”
– “One of the main motivators in neighborhoods like
where I come from is money…Money you know is the
motivator and the thing is, there are people who are
desperate enough in this time, black, white, whatever,
but impoverished, who are going to say, you know
what – I need that $20”
– “The relationship with the primary physician”
In their own words….
• What keeps you from participating?
– “It’s the way it is presented – it is very intimidating and
it’s overwhelming”
– “A lot of times it’s the language that’s used because a
lot times it’s lay people, it’s elderly people who don’t
have a clue about the basic diagnosis, let alone a
clinical trial”
– “A lot of people can’t read”
– “You know you need to be there, but due to the fact
that you’re illiterate, the fact that you cannot
understand, you’re not going to participate.”
In their own words….
• What are thoughts about the video?
– “It makes you want to sign up”
– “It was a good video. But let’s not forget the fact that
what this is, is basically targeted recruitment; you see
what I am saying? And in recruitment, you have to
look further than what you’re presented”
– “As a people, especially African-American people, we
need to be embraced, we need to be loved.”
– “I feel we are seen and we are heard”
Next Steps
• Share findings with an advisory board made up of THM
participants
– Did we hear you correctly?
– How can we use this information to change and
improve the way we conduct our research?
• Further engagement
– Individual interviews exploring mistrust and fear
– Train the trainer project
– IRB training
Questions?