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Fostering Collaborative Community-Based
Clinical and Translational Research:
Maryland Models Addressing Barriers to
Clinical Trial Participation for Underserved
Communities
Claudia R. Baquet, MD, MPH
Professor of Medicine
Associate Dean Policy and Planning
University of Maryland School of Medicine
National Center for Research Resources (NCRR) Workshop
May 15, 2007
CRBaquet, MD, MPH 2007
Assuring Diversity in
Clinical Research Participation
• A national priority.
• Minority, uninsured, poor, and rural communities
have lower participation rates in medical research.
• Underserved communities experience substantial
health disparities.
• Barriers to clinical research participation exist.
• Building academic-community partnerships and
community trust is essential.
CRBaquet, MD, MPH 2007
Overview of Presentation
• Research documented barriers to and significance
of under representation of minorities and rural
communities in clinical research and trials
• Maryland Models:
– Clinical Trials Barrier Needs Assessments
– Community-based Rural Cancer Trial Education,
Infrastructure
– HHS Best Practice Award for cancer clinical trials model
– State Policy Initiatives
– Mini Medical Schools
– Community Research Literacy and Research Translation:
• Community-Academic Partnerships
• Community Clinical Partnerships
CRBaquet, MD, MPH 2007
Clinical Trial Participation
• About 3–5% by cancer patients
• Low participation by underserved groups (African
American, uninsured, poor, rural) and a declining
percentage of African Americans participating.
• Slightly less than one-third (32%) of Americans would
be willing to participate in clinical trials if asked, and,
an additional 38% would be inclined to participate if
asked but had some questions or reservations.
– Factors other than patient intent or willingness
seem to present barriers to participation in clinical
trials.
CRBaquet, MD, MPH 2007
Clinical Trial Participation
• Low participation rates in cancer trials by African Americans
and other minorities may contribute to avoidable disparities in
cancer, including substantially higher cancer incidence,
morbidity and mortality rates.
• Increased awareness and intensive educational programs,
guided by research on trial barriers, increased availability
trials, and trial related policies, will increase the access to and
likelihood of participation in clinical trials by underserved
patients.
• Recent reports have focused on the policy implications and
the role of state legislation in addressing access,
reimbursement for and participation in clinical trials.
CRBaquet, MD, MPH 2007
Barriers to Clinical Research
Participation
•
•
•
•
•
Patient
Health care professional
Structural or organizational
Poor knowledge and awareness in general public
Insufficient community infrastructure to support clinical
research and trials
• Lack of support for community outreach
– absence of convenient transportation in rural and
urban communities
• Lack of basic knowledge of role of clinical research in
improving health
• Historical factors and exploitative research
CRBaquet, MD, MPH 2007
Patient Barriers
•
•
•
•
•
•
Attitudes toward research
Mistrust of researchers
Mistrust of research institutions
Fear
Culture and religion
Lack of information/knowledge
CRBaquet, MD, MPH 2007
Health Care Professional Barriers
• Lack of information on available clinical studies
• Views regarding research benefits and risks
• Lack of:
– understanding of research design
methodologies and requirements
– administrative support and reimbursement
• Fear of losing patients or control over patient
care
CRBaquet, MD, MPH 2007
Researcher/Investigator Barriers
• Failure to recognize the importance of utilizing
culturally sensitive approaches
• Failure to recognize fear or distrust of academic
institutions and researchers by patients and/or
community
• Lack of training in:
– culturally competence
– culture and health disparities
• Lack of awareness of patient fears / distress
• Failure to implement participatory research with
community groups
• Poor communication skills
CRBaquet, MD, MPH 2007
Predictors of Clinical Trial
Recruitment and Participation
in Maryland
Baquet CR, et al. Recruitment and Participation in
Clinical Trials: Socio-Demographic, Rural/Urban, and
Health Care Access Predictors.
Cancer Detection and Prevention. 2006; 30.
CRBaquet, MD, MPH 2007
Overview: Cancer Clinical Trials
•
Clinical trials are critical for the discovery and development of new
prevention, diagnostic and treatment modalities for disease.
•
Clinical trials have produced advances in cancer treatment and
prevention.
•
Despite these advances in cancer prevention and patient care, only 35% of cancer patients participate in clinical trials.*
•
Participation in cancer clinical trials is particularly low for African
Americans, the uninsured and poor, and rural patients.
– Low participation in cancer trials by African Americans and other
minorities may contribute to existing cancer survival and mortality
rate disparities.
– Low participation impedes translational research and research
translation
*Comis RL, Miller JD, Aldige CR, Krebs L, Stoval E. Public attitudes toward participation in cancer clinical trials. J
Clin Oncol. Mar 1 2003;21(5):830-835.
CRBaquet,
MD, MPH 2007
*Sateren WB, Trimble EL, Abrams J, et al.
How sociodemographics,
presence of oncology specialists, and hospital
cancer programs affect accrual to cancer treatment trials. J Clin Oncol. Apr 15 2002;20(8):2109-2117.
University of Maryland Barriers to
Clinical Trials Research
•
Survey of 5,154 English-speaking, non-institutionalized men and
women aged 18 years or older to examine the health behavior, clinical
trials barriers, health care access, and screening and health status of
Maryland residents
•
Conducted by the Center for Health Policy/Health Services Research
at the University of Maryland School of Medicine in 13 of the 24
jurisdictions in Maryland (December 2001-March 2003), including:
– urban Baltimore City
– rural Western Maryland (Garrett, Allegany, and Washington
counties)
– rural Eastern Shore (Cecil, Kent, Queen Anne’s, Talbot, Caroline,
Dorchester, Wicomico, Somerset, and Worcester counties)
•
Cross-sectional study design using random digit dialing (RDD)
methodology and Computer Assisted Telephone Interviewing (CATI)
data collection procedures
CRBaquet, MD, MPH 2007
Results
•
Of the 5,154 respondents, 574 respondents (11.1%) reported
previous recruitment into clinical trials
– Of those, 341 respondents (59.4%) actually participated in
clinical trials.
•
Respondents more likely (p<0.001) to be recruited to clinical trials:
– were 65 years or older (14.4%),
– had poor health status (17.7%),
– had some college or higher level of education (63.4%),
– had either
• private coverage (purchased directly or through work or
union, 32.0%) or
• public health insurance coverage (VA, Medicaid, or
Medicare, 51.7%), and
– were residents of urban Baltimore City (19.7%) followed by rural
Western Maryland (13.6%).
CRBaquet, MD, MPH 2007
Results (continued)
• Among those recruited, respondents who were significantly
(p<0.001) more likely to actually participate in clinical trials
were:
– white female (64.8%),
– white male (61.1%),
– male (100.0%) respondents from another race, and
– those residing in rural Western Maryland (68.9%) followed
by rural Eastern Shore (60.6%) versus those residing in
urban Baltimore City (47.0%).
CRBaquet, MD, MPH 2007
Multivariate Predictors of
Recruitment into Clinical Trials
•
Respondents who were significantly more likely to be recruited were:
– in poor health (OR=1.83, CI=1.21-2.76),
– had public health insurance coverage (OR=1.98, CI=1.57-2.51),
and
– had some college or higher level of education (OR=2.32,
CI=1.84-2.92).
•
Respondents who were significantly less likely to be recruited were:
– black (OR=0.61, CI=0.44-0.85),
– residents of rural Western Maryland (OR=0.46, CI=0.33-0.65),
and
– residents of rural Eastern Shore (OR=0.30, CI=0.22-0.40).
CRBaquet, MD, MPH 2007
Multivariate Predictors of Participation
in Clinical Trials
• Respondents who were significantly more likely to actually
participate in clinical trials:
– were informed about clinical trials by their health care provider
(OR=1.69, CI=1.08-2.65),
– were knowledgeable about clinical trials (OR=2.09, CI=1.263.46), and
– were able to make the time commitment (OR=1.67, CI=1.062.63)
• Respondents who were less likely to participate in clinical
trials:
– blacks (OR=0.38, CI=0.21-0.68) and
– middle-income respondents (OR=0.57, CI=0.37-0.89).
CRBaquet, MD, MPH 2007
Best Practice Model –
Proven Model to Increase Rural
Community-based Cancer Trials:
Community-Academic-Clinical
Partnership
F
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H
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B
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CRBaquet, MD, MPH 2007
UMSHN Telemedicine/Videoconference
Linkages Unique Infrastructure
(3)
Allegany
Allegany
1.
3.
(3)
Washington
Washington
Carroll
Carroll
Garrett
Garrett
Frederick
Area Served
Balt.
Balt.
City
City
Kent
Kent
(13)
Anne
Anne
Arundel
Arundel
Eastern Shore
Regional Office
Queen
Queen
Anne’s
Anne’sCar
(1)
Area Served
Baltimore City
Baltimore
-
oline
(2)
Caroline, Cecil, Dorchester, Kent,
Queen Anne’s,. Talbot, Somerset,
Wicomico and Worcester Counties
Caroline
Baltimore City
Regional Office
(1)
Baltimore
Howard
Howard
(1)
Montgomery
UMSHN Offices
Cecil
Cecil
Harford
Harford
Talbot
Prince
Prince
Talbot
George’s
George’s
(1)
(1)
2.
Charles
Western Maryland
Regional Office
Area served
Garrett County, Allegany
County, Washington, and
Frederick Counties
Southern Maryland
Regional Office
Area Served
Calvert, Charles and St.
Mary’s Counties
Covered for
community &
professional health
education through
NIH P-60 funding
Calvert
Cal vert
Charles
Dorchester
Dorchester
Wicomico
Wicomico
St. Mary’s
(2)
St. Mary’s
(1)
Somerset
Worcester
Worcester
Somerset
(1)
4.
(1)
UMSHN Offices
1.
2.
3.
4.
Central Office/Baltimore City Office
Eastern Shore Regional Office - Salisbury
Western Maryland Regional Office - Hagerstown
Southern Maryland Regional Office - Waldorf
Telemedicine/Videoconference
Linkages (32)
(#) reflect number of TM/VC
linkages
CRBaquet, MD, MPH 2007
Strategies for Overcoming Barriers and
Increasing Participation
PARTNERSHIPS between academic institution and community:
• General Public and Ministers Baltimore City Model (Times Community
Services)
• Clinical Eastern Shore (Eastern Shore Oncology)
COMMUNITY PARTICIPATION AND CENTERED
• Faith and community based organizations: Ministerial Alliances
• Print and broadcast media
• Local health departments and community hospitals and FQHCs
• Policy makers
TRAINING for research personnel regarding:
– community concerns
– culturally sensitive communication
– sharing results
INFRASTRUCTURE: Cover expenses and outreach
COMMUNITY HEALTH PROFESSIONAL education
- Physicians and Nurses
- Rural and Urban CRBaquet, MD, MPH 2007
Maryland Clinical Research
Partnership Model
HHS Committee on Science and Public Health:
National HHS Best Practice Award
• A Model For Increasing Availability Of
Community-Based Cancer Clinical Trials In Rural
Eastern Shore Maryland, September 2004.
[email protected]
• CBaquet, MD and MDeShields, MD
CRBaquet, MD, MPH 2007
Maryland Community Clinical Trial Program
Supported by: MSPN/CNP NCI ; MD CRF; Susan G. Komen Foundation Maryland; NIH NCMHD P 60
Ministers and churches, health
professionals
Eastern Shore Oncology-UMSOM
•
Rural Community Cancer Clinical Trials
Education and Availability Focus
•
•
Multi-Pronged Approach
– Community education and
awareness
– Physician and other health
professional continuing education
– Trial infrastructure development;
clinical nurse educator and nurse
clinical trial data manager
Outcomes:
– In five years: 18 fold increase in
cancer protocols open
– 40 fold patient accrual to trials
– 25% rural African American cancer
patients
– Favorable external rigorous audits
by: CTSU, ECOG, other CGs
•
Maryland surveys and
qualitative research to identify
barriers to clinical trials:
–
80.0% of Blacks and 50.9% of
Whites reported not knowing what
a clinical trial is.
–
Over 95% of all respondents
reported their physician never
discussed clinical research/trials.
•
“National Best Practice Award”
from DHHS Secretary and
Committee on Science and Policy
HHS “A Model for Increasing
Availability of Community-Based
Cancer Trials in Rural Eastern
Shore, MD - September 2004
[email protected]
CRBaquet, MD, MPH 2007
Essential Components of Successful
Community and Clinical Research Partnerships
• Strong leadership by a local community physician.
• Shared benefits and commitment to the partnership,
ongoing grant support by federal, state and private
funds.
• On site nurse community educator and nurse data
manager.
• Investment clinical trial/research infrastructure.
• Intensive health professional continuing education
and community education.
• Extensive outreach.
CRBaquet, MD, MPH 2007
Funding Sources
Partnerships supported by funding sources include:
• “Maryland Special Populations Cancer Research
Network” (grant no. NCI 5CA86249 CBaquet PI) 20002005.
• Maryland Cigarette Restitution grant, “University of
Maryland Statewide Health Network”. 2002-present
(CBaquet PI)
• UM Comprehensive Health Disparities Research,
Outreach and Training Center; NIH: NCMHD Grant
Number P60 MD000532-01 (DWilson PI, CBaquet
CoPI); 9/30/03-present.
• Maryland Regional Community Network Program (grant
no. NCI U01CA114650 CBaquet PI 2005-present)
CRBaquet, MD, MPH 2007
Considerations
• Lack of trial availability
• Ethical issues related ineligible
patients and high co morbid conditions
• Community participation and centered
• Include community in research literacy
efforts for basic/preclinical research
and translational studies
CRBaquet, MD, MPH 2007