The Importance of Minority Participation in Clinical Trials Lovell A. Jones, Ph.D., Research Faculty Texas A & M University Corpus Christi Professor Emeritus.

The Importance of Minority Participation in

Clinical Trials

Lovell A. Jones, Ph.D., Research Faculty

Texas A & M University Corpus Christi

Professor EmeritusUniversity of Texas M. D. Anderson

Cancer CenterUniversity of Texas Graduate School of

Biomedical Sciences

Bridging the Gap Between Community Needs and Clinical Research

1st Annual National African American Breast CancerConference

Houston, TexasApril 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 societywe 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

Recent data suggest that

African American women in

Houston are now equally

likely to get breast cancer as

Caucasians…which is highly

unusual in the U.S.!

NH Black and NH White Breast Cancer Mortality, Houston, 1995-2004

Age-Adjusted Female Breast Cancer Mortality for Houston, Per 100,000 Women

41.3

28.2

32.8

40.8

NH Black and NH White Breast Cancer Mortality Rates, Chicago, 1980-2005

Age-Adjusted Female Breast Cancer Mortality for Chicago, Per 100,000 Population

38.1

37.4

41.4

19.2

How Have WeDefined RaceIn America?

How Do We Explain Racial And Ethnic

Disparities In Health?

Definitions of Race1) 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

Jackson, 2004

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

85% variation 85% variation withinwithin ““racerace””

15% variation 15% variation betweenbetween ““racesraces””

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

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

Chesapeake Bay Region

Bight of Bonny Region

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.

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.

Fatimah Jackson, Ph.D. 2006 Transforming Anthropology 14(2):126-130.

SO WHICH OF THESE INDIVIDUALS ISBIOLOGICALLY WHITE NON-HISPANIC, WHITE HISPANIC,

ASIAN, AFRICAN AMERICAN OR NATIVE AMERICA?

Rick Kittles

88% West African12% European

68% European16% West African16% 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 African-American 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.

If You Always Do What You Have Always Done.... You’ll Always Get What You Always Got!

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

Moms “Jackie” Mabley

THE GRASSROOTS DEFINTION OF INSANITY

CLINICAL TRIALSCLINICAL 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

Barriers to Clinical Trials

TOP TEN REASONS

WHY MINORITIES ARE NOT ENROLLED

ON 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 prevails7. 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.

Top Ten Reasons For Minorities Not Being Enrolled Into Clinical Trials

LACK OF PHYSICIAN RECOMMENDATION

&PHYSICIAN BIAS

NUMBER 1 REASONMINORITIES DO NOT

PARTICIPATE IN CLINICAL TRIALS

PERCEPTION VS REALITY

A PERSON’S PERCEPTION IS A PERSON’SREALITY

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 IF THE PROBLEMS ARE IN THE COMMUNITY, THEN COMMUNITY, THEN

COMMUNITIES MUST BE COMMUNITIES MUST BE INVOLVED IN DETERMINING INVOLVED IN DETERMINING

THE SOLUTIONSTHE SOLUTIONS

MODIFIED PATIENT NAVIGATOR PROGRAM

Participant Recruitment

ScreeningClinical Findings

Additional Test Enroll in the Study

Referred For Treatment Continued Follow up

Health Outcome

Impact on Recruitment

(-)

(+)

* 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.

FAROS

Screening

The Patient Navigation ModelThe Cancer Care Continuum

Community HealthWorkers

Community HealthWorkers

Patient Navigators

Health Referral Specialist

IMPaCT Report Date Range: 09/01/2006 to 01/31/2010

Patients Educated about CT and IMPaCT 292 Enrolled in IMPaCT Not Enrolled in IMPACT Total Patients Potentially Eligible for CT 93 40 133 Enrolled in IMPaCT Not Enrolled in IMPACT Not Yet Consented to CT (Recruitment): 30 29 Ineligible: 8 (27%) 14 (48%) Pending: 0 (0%) 1 (3%) Eligible: 22 (73%) 14 (48%) Declined CT 5 (23%) 13 (93%) Enrolled in CT 17 (77%) 1 (7%)

Currently Enrolled in CT 2 0 Completed CT 14 1

Withdrawn Self 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

•Trust Respect

Solutions

•

Partnership•

CommunicationFlexibility

• Knowledge

••

SIX KEY WORDS TO THE SOLUTION

a

Gilism #1001Gibert Friedell, M.D.

QUESTIONS

Contact InformationLovell A. Jones, Ph.D.Professor EmeritusU.T. Distinguished Teaching ProfessorUniversity of Texas M.D. Anderson Cancer CenterUniversity of Texas Graduate School of Biomedical SciencesCo-Founder, Intercultural Cancer CouncilChair, Board of Directors, Children and Neighbors Defeat Obesity (CAN DO) Houston11511 Mulholland DriveStafford, Texas. [email protected]://stylemagazine.com/staff/dr-lovell-jones/