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The Importance of
Minority Participation in
Clinical Trials
Bridging the Gap Between Community
Needs and Clinical Research
Lovell A. Jones, Ph.D.,
Research Faculty
Texas A & M University Corpus Christi
Professor Emeritus
University of Texas M. D. Anderson
Cancer Center
University of Texas Graduate School of
Biomedical Sciences
1st Annual National African American Breast Cancer
Conference
Houston, Texas
April 1999
National Minority Cancer Awareness Week
Race
Perhaps the single most
defining issue in the history
of American society
Harold Freeman, M.D.
In our society
we see, value, and
behave toward one
another through a
powerful lens of
race.
A Recent Local Example
of a Critical Disparity
Houston Chronicle, Feb 5, 2008
Black women in Houston are
45% more likely to die of
breast cancer than white
women
The racial disparity gap in
breast cancer mortality rates
in Houston is higher than the
national average
…and worsening
NH Black and NH White Breast Cancer
Mortality, Houston, 1995-2004
41.3
40.
8
32.8
28.
2
Age-Adjusted Female Breast Cancer Mortality for Houston, Per 100,000 Women
NH Black and NH White Breast Cancer
Mortality Rates, Chicago, 1980-2005
41.4
38.1
37.4
19.
2
Age-Adjusted Female Breast Cancer Mortality for Chicago, Per 100,000 Population
How Have We
Defined Race
In America?
How Do We Explain
Racial And Ethnic
Disparities In Health?
Definitions of Race
1) A local, geographic or global human population distinguished
as a more or less distinct group by genetically transmitted
physical characteristics.
2) A group of people united or classified together on the basis of
common history, nationality, or geographic distribution...
3) Human beings considered as a group.
The American Heritage Dictionary of the English Language, 1992
4) A vague, unscientific term for a group of genetically related
people who share certain physical characteristics.
5) A distinct ethnic group characterized by traits that are
transmitted through their offspring.
Mosby’s Medical, Nursing, and Allied Health Dictionary, 1994
PREDOMINANT AFRICAN CULTURAL INFLUENCES ON
AFRICAN AMERICANS
•
•
•
•
•
•
Bight of Benin region traditions
•
Yoruba
West Central Africa region traditions
•
Kongo
Upper Guinea Coast region traditions
•
Various Mande-speaking groups
Bight of Bonny region traditions
•
Ibo and Ejaham
Senegambian region traditions
•
Wolof, Bambara, Mandingo, Fulbe
Gold Coast region traditions
•
Various Akan-speaking groups
Jackson, 2004

85% variation within “race”

15% variation between “races”
Marcus Feldman, Ph.D.
Population Geneticist, Stanford University
Figure 3. The migration of modern Homo sapiens.
The scheme outlined above begins with a radiation from East Africa to the rest of Africa about 100 kya
and is followed by an expansion from the same area to Asia, probably by two routes, southern and
northern between 60 and 40 kya. Oceania, Europe and America were settled from Asia in that order.
Likely Genetic Connections
Between the Bight of Bonny and
the Chesapeake
Bay Populations
Chesapeake Bay Region
Bight of Bonny Region
The largest component of Africans brought to the
Chesapeake Bay came from the hinterlands of
the Bight of Bonny West Africa. This area
includes SE Nigeria, W Cameroon, Equatorial
Guinea, and N Gabon.
Redrawn from Jackson 2008
Over 50% of the Breast patients at
UNTH Enugu, Nigeria in 2004-2005
showed a high incidence of
premenopausal patients in the 20-40
years age range.
14
12
10
8
6
Count
4
2
0
20yr
31yr
29yr
AGE
36yr
34yr
40yr
38yr
45yr
43yr
49yr
47yr
53yr
51yr
57yr
55yr
62yr
60yr
71yr
66yr
Fatimah Jackson, Ph.D. 2006
Transforming Anthropology 14(2):126130.
SO WHICH OF THESE INDIVIDUALS IS
BIOLOGICALLY WHITE NON-HISPANIC, WHITE HISPANIC,
ASIAN, AFRICAN AMERICAN OR NATIVE AMERICA?
88% West African
12% European
Rick Kittles
68% European
16% West African
16% Native American
Diseases with prevalence differences
• Obesity (> in African-American women and Native American,
and Hispanic populations)
• Type 2 diabetes (> in Native American, Hispanic, and AfricanAmerican populations)
• Hypertension (> in African-American populations)
• End Stage Renal Disease (> in Native American, Hispanic, and
African-American populations)
• Cancer
• Skin cancer (> in European-American)
• Prostate Cancer (> in African-American)
• Lung Cancer (> in African-American)
• Breast Cancer (early age of onset in African American)
INSANITY:
Continuing to do things the same way and expecting a different outcome.
THE GRASSROOTS DEFINTION OF INSANITY
If You Always Do What You
Have Always Done....
You’ll Always Get What You
Always Got!
Moms “Jackie” Mabley
Unfortunately, when we approach efforts to deal with the lack of real
progress in addressing health disparities, we tend to fall back to what we
have done before. It may be under a different name or packaged in a
different box, but ultimately it is the same strategy.
Lovell A. Jones 1999
CLINICAL TRIALS
Barriers to Clinical Trials
• Fear of unethical treatment
• Distrust of the investigator’s motives
• An incomplete understanding of their benefits,
responsibilities, risk, and the safeguards for study
subjects
• The investigators’ apparent lack of respect for the
subjects and their cultures.
• The history of episodic research without long-term
program having, tangible benefits
• Cost and/or lack of insurance
• Lack of access to clinical trials (transportation,
child care, time off of work) and
• lack of true partnerships in study design
TOP TEN REASONS
WHY MINORITIES ARE
NOT ENROLLED ON
CLINICAL TRIALS
Top Ten Reasons For Minorities Not Being
Enrolled Into Clinical Trials
10. Time consuming for physicians and staff to explain and translate
protocols and consent forms.
9. Lack of awareness of existing protocols by physicians and the
community
8. Concept of being guinea pigs prevails
7. Lack of bilingual providers and the use of translators.
6. Time-consuming for patients who cannot take time off from work
and/or children.
5. Financial constraints and requirements of costly diagnostic
procedures at specific times during the course of their treatment.
4. Treatment protocols not available at the patient's preferred
treatment site.
3. Different tumor incidence in minority groups compared to whites.
2. Lack of protocols specific for cancer seen most often in minority
populations.
1. The number one reason, the biggest of them all, lack of
understanding of minorities' knowledge, attitudes and practices
regarding cancer with resulting poor protocol planning.
NUMBER 1 REASON
MINORITIES DO NOT
PARTICIPATE IN CLINICAL TRIALS
LACK OF PHYSICIAN
RECOMMENDATION
&
PHYSICIAN BIAS
PERCEPTION VS REALITY
A PERSON’S PERCEPTION IS A PERSON’S
REALITY
Unconscious
Discrimination
• When one holds a negative stereotype
about a group and meets someone who
fits the stereotype s/he will discriminate
against that individual
• Stereotype-linked bias is an
– Automatic process
– Unconscious process
• It occurs even among persons who are
not prejudiced
WHO YOU ARE SHAPES
HOW YOU LOOK AT PROBLEMS
BIOPSYCHOSOCIAL RESEARCH
IF THE PROBLEMS ARE IN THE
COMMUNITY, THEN
COMMUNITIES MUST BE
INVOLVED IN DETERMINING
THE SOLUTIONS
MODIFIED PATIENT NAVIGATOR PROGRAM
Participant Recruitment
Screening
Clinical Findings
Impact on Recruitment
(-)
Additional Test
Enroll in the Study
(+)
Referred For Treatment
Continued Follow up
Health Outcome
The Patient Navigation Model
The Cancer Care Continuum
FAROS
Screening
Community Health
Workers
Patient Navigators
Community Health
Workers
Health Referral Specialist
* FAROS expands the Freeman model to include CHW to navigate older
Latinos through screening & PN at the point of suspicious findings onward
to the community and life after cancer.
IMPaCT Report
Date Range: 09/01/2006 to 01/31/2010
Patients Educated about CT and IMPaCT
292
Enrolled in IMPaCT
Patients Potentially Eligible for CT
Not Enrolled in IMPACT
40
93
Enrolled in IMPaCT
Not Yet Consented to CT (Recruitment):
Ineligible:
Pending:
Eligible:
Declined CT
5 (23%)
Enrolled in CT
17 (77%)
Currently Enrolled in CT 2
Completed CT 14
Withdrawn Self 1
Not Enrolled in IMPACT
29
14 (48%)
1 (3%)
14 (48%)
13 (93%)
1 (7%)
30
8 (27%)
0 (0%)
22 (73%)
0
1
0
Enrolled in IMPaCT
Not Enrolled in IMPACT
Already Consented to CT (Retention):
63
11
Ineligible:
0 (0%)
1 (9%)
Pending:
0 (0%)
0 (0%)
Eligible:
63 (100%)
10 (91%)
Declined CT
0 (0%)
0 (0%)
Enrolled in CT
63 (100%)
10 (100%)
Currently Enrolled in CT 14
3
Completed CT 43
7
Withdrawn Self 6
0
Total
133
SIX KEY WORDS TO THE SOLUTION
• Trust
• Respect
Solutions
• Partnership
• Communication
• Flexibility
• Knowledge
Gilism #1001
Gibert Friedell, M.D.
a
QUESTIONS
Contact Information
Lovell A. Jones, Ph.D.Professor Emeritus
U.T. Distinguished Teaching Professor
University of Texas M.D. Anderson Cancer Center
University of Texas Graduate School of Biomedical
Sciences
Co-Founder, Intercultural Cancer Council
Chair, Board of Directors,
Children and Neighbors Defeat Obesity
(CAN DO) Houston
11511 Mulholland Drive
Stafford, Texas. 77477
[email protected]
713-582-8296
http://stylemagazine.com/staff/dr-lovell-jones/