The Importance of Minority Participation in Clinical Trials

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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

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1st Annual National African American Breast
Cancer Conference Houston, Texas April
1999 National Minority Cancer Awareness Week
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Race Perhaps the single most defining issue in
the history of American society
Harold Freeman, M.D.
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In our societywe see, value, and behave toward
one another through a powerful lens of race.
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• 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

Recent data suggest that African American women
in Houston are now equally likely to get breast
cancer as Caucasianswhich is highly unusual in
the U.S.!
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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
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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
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How Have WeDefined RaceIn America?
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How Do We Explain Racial And Ethnic Disparities
In Health?
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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.
Mosbys Medical, Nursing, and Allied Health
Dictionary, 1994
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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
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• 85 variation within race
• 15 variation between races

Marcus Feldman, Ph.D. Population Geneticist,
Stanford University
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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.
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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
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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.
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Fatimah Jackson, Ph.D. 2006 Transforming
Anthropology 14(2)126-130.
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SO WHICH OF THESE INDIVIDUALS IS BIOLOGICALLY
WHITE NON-HISPANIC, WHITE HISPANIC, ASIAN,
AFRICAN AMERICAN OR NATIVE AMERICA?
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Rick Kittles
88 West African 12 European
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68 European 16 West African 16 Native American
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Diseases with prevalence differences

• Obesity (gt in African-American women and Native
  American, and Hispanic populations)
• Type 2 diabetes (gt in Native American, Hispanic,
  and African-American populations)
• Hypertension (gt in African-American populations)
• End Stage Renal Disease (gt in Native American,
  Hispanic, and African-American populations)
• Cancer
• Skin cancer (gt in European-American)
• Prostate Cancer (gt in African-American)
• Lung Cancer (gt in African-American)
• Breast Cancer (early age of onset in African
  American)

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INSANITY Continuing to do things the same way
and expecting a different outcome.
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THE GRASSROOTS DEFINTION OF INSANITY
If You Always Do What You Have Always Done....
Youll 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
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CLINICAL TRIALS
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Barriers to Clinical Trials

• Fear of unethical treatment
• Distrust of the investigators 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

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TOP TEN REASONS



WHY MINORITIES ARE

NOT ENROLLED ON

CLINICAL TRIALS
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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.
• Lack of awareness of existing protocols by
  physicians and the community
• 8. Concept of being guinea pigs prevails
• Lack of bilingual providers and the use of
  translators.
• 6. Time-consuming for patients who cannot take
  time off from work and/or children.
• 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.
• 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.

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NUMBER 1 REASON MINORITIES DO NOT PARTICIPATE IN
CLINICAL TRIALS
LACK OF PHYSICIAN RECOMMENDATION PHYSICIAN BIAS
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PERCEPTION VS REALITY
A PERSONS PERCEPTION IS A PERSONS REALITY
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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

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WHO YOU ARE SHAPES HOW YOU LOOK AT PROBLEMS
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BIOPSYCHOSOCIAL RESEARCH
IF THE PROBLEMS ARE IN THE COMMUNITY, THEN
COMMUNITIES MUST BE INVOLVED IN DETERMINING THE
SOLUTIONS
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MODIFIED PATIENT NAVIGATOR PROGRAM
Participant Recruitment
Impact on Recruitment
Screening
Clinical Findings
(-)
Enroll in the Study
Additional Test
()
Continued Follow up
Referred For Treatment
Health Outcome
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The Patient Navigation Model The Cancer Care
Continuum
FAROS
Screening
Community Health Workers
Community Health Workers
Patient Navigators
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.
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SIX KEY WORDS TO THE SOLUTION
Trust Respect


Solutions

Partnership

Communication

Flexibility
Knowledge
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Gilism 1001 Gibert Friedell, M.D.
a
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QUESTIONS
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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 Lovell.Jones_at_tamucc.edu 713-582-8296 http//
stylemagazine.com/staff/dr-lovell-jones/