WHY WE NEED TO TELL THIS
STORY
Three friends-Jim, Bill and Peter-- were walking down the
street. Jim said, "I gave blood today." Peter said, "That's
terrific! You are a scholar and a gentleman."
Bill said, "After a lot of thought, I've decided to donate a
kidney." Jim said, "That's beyond terrific! You are a
prince among men."
Peter said, "Well, I'm not giving blood, and I'm not
donating a kidney, but I plan to enroll in a clinical trial
tomorrow." Jim and Bill said, "What? Are you crazy?"
PUBLIC PERCEPTION IS POOR
RECRUITMENT COSTS ARE
INCREASING
Study
Recruitment Target
Actual # Recruited
H.Pylori testing
eradication vs
empirical acid
suppressions
730
70
Closed at 19 months
Early endoscopy vs.
usual management in
patients (+) for
H.Pylori
800
272
Closed at 18 months
H.Pylori testing and
eradication with
endoscopy of not
improved versus early
endoscopy
500
500
Closed at 14 months
Foy, 2003
 Continuing
medical education for physician
and staff
 Printed
educational materials for subjects
 Incentives
 Use
to patients
of local opinion leaders
 Minorities
are less likely to enroll in studies
compared to white males
 Despite high disease burden, less than 5% of
participants in Breast and Prostate Cancer
prevention trials were minority
 1996 to 2002 annual # of trial participants
increased from 8,000-12,000 but minority
participation decreased. Hispanic & Blacks
represented 3.7% and 11.0% in 1996 but down
to 3.0% and 7.9% in 2002
Murthy, 2004
Local Data:
Fox Chase Cancer Center (Northeast
Philadelphia)-data from 2004
Catchment area: 18% Black, 6% Hispanic, 3%
Asian, 71% White
Minority patient accrual: 8% Black, 2%
Hispanic, 1% Asian, 89% White
Minority patient recruitment: 6% Black, <1%
Asian and Hispanic each
•
Bruner, 2006
Minority Participation: UH Experience
 UMDNJ
– University Hospital (UH) data
In 2007 there were 1132 newly identified cancer
patients: 32% white NH, 35% black NH,
23% Hispanic.
There were 43 active cancer trials that enrolled a
total of 54 patients, representing an overall
enrollment rate of 4.8%.
5.1% of blacks enrolled (20/396)
4.6% of Latinos enrolled (12/260)
Thus, participation rates among racial and ethnic
groups were similar at UH.
 Protocol
issues
 Adequate Funding
 Site Selection
 Investigator Selection
 Time
Constraints
 Lack of support staff
 Impact on doctor-patient relationship
 Concern for patients
 Clinician bias
 Loss
of professional autonomy
 Obtaining consent
 Poor financial reimbursement
 Lack of interest in the specific research
question
 Demands
of the study
 Preference for a particular treatment
 Concerns about side effects
 Comfort level with physician
 Language and literacy
 Loss of privacy
 Portrayal as guinea pig
 Mistrust
of scientific investigators and of
academic institutions were major barriers
among Blacks
Providing informed consent was reported as
relinquishing rather than protecting rights
Research volunteer is considered a“guinea pig”
Knowledge of the Tuskegee Syphilis Study was
not necessarily negatively associated with
willingness to participate
Yancey, 2006
Belief
Blacks (%)
Whites (%)
Risks equally shared by
all racial/ethnic groups
34.6
40.5
Minorities bear most of
the risk
25.2
5.2
Risks equally shared by
rich and poor
22.8
57.8
Poor bear most of the
risks
65.9
42.2
Rich bear most of the
risks
11.3
0
Shavers, 2002
 Systematic
review to determine barriers to
participation of underrepresented
populations in cancer trials: 1966-2005
Barriers to:
-trial awareness
-opportunity to participate (research design,
provider attitudes)
-acceptance of enrollment (perceived harms,
mistrust)
--additional barriers related to cultural factors
Ford, 2007
Examination of Community Members’, Researchers’ and
Health Professional perceptions of barriers to minority
recruitment (Robinson JM, 2007)
 Cluster: Recruitment Issues
Minorities unaware of medical research
Lack of cultural sensitivity in communications
Lack of resources to treat the uninsured if found to be sick
 Cluster: Patient concerns
Lack of awareness of benefits to participation
Sense that subjects only give and get nothing
Concerns about signing ICF
 Cluster: Fears
Fear of being a guinea pig
Fear of unknown

Cluster: Psychosocial/socioeconomic issues
More pressing survival problems
Cultural beliefs/Religious beliefs
Mental illness, homelessness

Cluster: History/past experiences
Previous negative experience
Literacy issues
Mistrust due to discriminatory social/historical/legal experiences

Cluster: Resources/Financial considerations
Lack of health coverage to reimburse medical interventions in
protocol
Presentation at late stage for many minority patients
Dismal past record of translating research into practice in
underserved community
Cluster: Research System Issues
Lack of adequate MD education in providing patient’s
information about trials
Lack of incentive for overworked MDs caring for minorities
Inappropriate outreach methods
 Cluster: Researcher Bias
MD fear of losing patients
Poor Relationship between medical institution and community
Lack of follow-up
 Cluster: Issues in Research Method, Design, Management
Not linking research to what minority communities need
Lack of minorities as PI
Lack of bilingual researchers

Outreach worker
Researcher
Issues with methods
Pt. concerns about research
Research system issues
Research system issues
Resources/ Financial
Recruitment Issues
Recruitment Issues
Fears
Pt concerns about research
Issues with methods
MD Bias
Resources/Financial
History/past experiences
MD Bias
Fears
Psychosocial/socioeconomic
Psychosocial/socioeconomic
History/past experiences
R=.29
Lay community
Steering Committee
Pt. concerns about research
Research System Issues
Fears
Pt. concerns about research
Psychosocial/Socioeconomic
Recruitment Issues
Issues in research methods
Issues in Research Methods
MD Bias
Fears
History/ Past Experiences
Resources/Financial
Research system Issues
History/past experiences
Resources/Financial
MD Bias
Recruitment Issues
Psychosocial/socioeconomic
R=.11
Lay community
Outreach worker
Pt. concerns about research
process
Issues with methods
Fears
Research system issues
Psychosocial/Socioeconomic
Resources/ Financial
Issues in research methods
Recruitment Issues
MD Bias
Pt concerns about research
History/ Past Experiences
MD Bias
Research system Issues
History/past experiences
Resources/Financial
Fears
Recruitment Issues
Psychosocial/socioeconomic
R=-.16
 NIH
Revitalization Act mandated minority
inclusion in randomized clinical trials, 1993
 Review criteria in NIH study sections have
formally required minority recruitment or
scientific justification for their exclusion
 Rep. Edolphus Towns (Democrat, NY) was
expected to submit legislation that would
offer delayed generic competition to
companies that conduct minority focused
clinical trials.
 Passive-disseminating
information in the
target population via flyers, advertisements,
mailings, public service announcements
 Active-bringing the project staff directly into
contact with prospective participants via
telephone or in-person appeals by project
staff and medical providers
 Use
lay outreach workers from the targeted
population (cultural insider)
 Community-based organizations particularly
for Blacks
 Places of Worship: Although some
investigators have identified religiosity as a
barrier due to a fatalistic view of disease –
others have found religiosity to be positively
associated with willingness to participate
Very few patients are aware that they are eligible to participate
In a clinical trial
What is it?

One day educational program free and open to the public

Local physician speakers provide information to help people make
informed decisions about clinical research participation
 General session lecture –
“What Clinical Research Means to You!”
 Educational workshops –
focused on disease states and issues such as women or
minorities in clinical research
 Patient Panel –
real life stories of clinical research participation
Purpose and Value
 Takes
awareness-building into the heart of the
community via traditional outreach and advocacy
strategies
 Builds a grass-roots movement by engaging and
informing political figures, opinion leaders,
physicians, healthcare providers and other
stakeholders
 Changes perception of the clinical research
participant from that of “guinea pig” to that of
Hero
Attendee Evaluations
Self-reported knowledge of the clinical research process:
Attendees who were not previously in a clinical trial
Poor (24%)
Fair (29%)
Good (33%)
Excellent (14%)
Poor (1%)
Fair (6%)
Good (51%)
Excellent (42%)
n = 66
Before AWARE for All
n = 65
After AWARE for All
Attendee Evaluations
Likelihood of participating in a clinical trial:
Less likely (3%)
No Change (22%)
More likely (75%)
n = 108
Recruitment Strategy: Minority
Principle Investigators

Minority investigators are under-represented
among the pool of all active clinical
investigators (Getz, 2008)
#
Minorities
who are PI
% minority
PI
% of all
PIs
White
% of white
MDs
involved
in
research
% of all
PIs
All clinical
research
14,187
(out of
136,416)
10.4%
16.7%
70,702
(out of
420,846)
16.8%
83.3%
Gov’t
funded
6,957
5.1%
19.1%
29,459
7.0%
80.9%
All
industry
funded
research
11,595
8.5%
17.1%
56,393
13.4%
82.9%
Recruitment Strategy: Friendly
Informed Consent





Health literacy: degree to which people can obtain,
process and understand basic health information and
services they need to make appropriate health
decisions. It is not just about reading and writing, but
includes all the ways people communicate health
information such as by speaking, drawing pictures
and using technology.
Most consents are on a 12th grade reading level
Provide consent in different languages, use “comfort”
words, pictures, diagrams
Voice-enhanced ICF
Yates, 2009 developed a 23 page ppt flip chart for an
IC-study comparing traditional cardiac rehab vs
home-based cardiac rehab-improved participation
rate from 22%-54%
Recruitment Strategy: Clinical Trial
Alert Systems
Configured the EHR to trigger an alert if a patient is likely
eligible for an ongoing clinical trial
CTA is set to trigger only during clinical encounters
If MD elects to proceed , a customized CTA order form
appears—reminds MD to assess a few additional eligibility
criteria
MD clicks appropriate box 1) yes patient meets criteria and is
interested;2. No, patient does not meet criteria; 3. No
patient meets criteria but not interested. Message sent to
trial coordinator’s workstation
 CTA addresses obstacles to MD participation in recruitment

Recruitment Strategy: General










Adequately characterize the target population
Involve members of the target population in planning
efforts
Take message to the target population
Give something back to the community
Enhance credibility of study by using a community
spokesperson
Identify and remove barriers to participation
Cultural relevance of materials
Improve staff sensitivity
Stress importance of prevention and early detection
Use of women to encourage participation by males
 Mass
mailing of brochures/flyers with
personalized letters -across ethnic groups
 Secondary source was referral by a friend for
Hispanics and Blacks and newspaper
ads/articles and brochures for whites
 Overall recruitment through the health
system produced a higher randomization
yield than did newspaper and radio public
service announcements or faith-based
organizations
 Recruits from faith-based organizations were
more likely to stay in the study
 Study
specific websites
 Email
 Banner
Advertising
 Chat rooms & forums
 Podcasts
 Search engine advertising
 Men—newspapers
 Elderly—TV
and newspapers
 Adult children and spouses of the patientdirect mail, newspapers, radio and online
advertising
 Young mothers--magazines and online
advertising
 Creative
 Get
noticed
 Offers news
 Compelling message
 Succinct message
 Meaningful to patient
 Use Emotion
 Pleasing colors
 Catchy study name
Conclusions
 There
is equal willingness among minorities
and whites to participate in clinical trials
 Lack of awareness and lack of understanding
of the benefits of participation are probably
the biggest obstacles
 Mistrust remains an issue
 Community involvement is imperative for
enrollment to grow
No more hand-me-downs:
Research Designed for
Children





Bruner, D.W., et al., Reducing cancer disparities for
minorities: a multidisciplinary research agenda to improve
patient access to health systems, clinical trials, and
effective cancer therapy. Journal of Clinical Oncology,
2008. 24(14): p. 2209-2215.
Ford J.G, et al., Barriers to recruiting underrepresented
populations to cancer clinical trials: A systematic review.
Cancer, 2008. 112(2): p. 228-242.
Foy, R., et al., How evidence based are recruitment
strategies to randomized controlled trials in primary care?
Experience from seven studies. Family Practice, 2003.
20(1).
Getz, K. and L. Faden, Racial disparities among clinical
research investigators. American Journal of Therapeutics,
2008. 15: p. 3-11.
Joseph, G., C.P. Kaplan, and R.J. Pasick, Recruiting lowincome healthy women to research: an exploratory study.
Ethnicity and Health, 2007. 12(5): p. 497-519.
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Murthy, V.H., H.M. Krumholz, and C.P. Gross, Participation
in cancer clinical trials. JAMA, 2004. 291(22): p. 27202727.
Robinson, J.M. and M.K. Trochim, An examination of
community members', researchers' and health
professionals' perceptions of barriers to minority
participation in medical research: an application of
concept mapping. Ethnicity and Health, 2007. 12(5): p.
521-539.
Shavers, V.L., C.F. Lynch, and L.F. Burmeister, Racial
differences in factors that influence the willingness to
participate in medical research studies. Annals of
Epidemiology, 2002. 12: p. 248-256.
Yancey, A.K., A.N. Ortega, and S.K. Kumanyika, Effective
recruitment and retention of minority research
participants. Annual Review of Public Health, 2006. 27: p.
1-28.
Yates, B.C., et al., Testing an Alternate Informed Consent
Process. Nursing Research 2009. 58(2): p. 135-139.