1 / 24

Claudia R. Baquet, MD, MPH Professor of Medicine Associate Dean Policy and Planning University of Maryland School of Med

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.

sandra_john
Download Presentation

Claudia R. Baquet, MD, MPH Professor of Medicine Associate Dean Policy and Planning University of Maryland School of Med

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. 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 Fostering Collaborative Community-Based Clinical and Translational Research: Maryland Models Addressing Barriers to Clinical Trial Participation for Underserved Communities CRBaquet, MD, MPH 2007

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Patient Barriers • Attitudes toward research • Mistrust of researchers • Mistrust of research institutions • Fear • Culture and religion • Lack of information/knowledge CRBaquet, MD, MPH 2007

  8. 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

  9. 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

  10. 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

  11. 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 3-5% 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. *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. CRBaquet, MD, MPH 2007

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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=1.26-3.46), and • were able to make the time commitment (OR=1.67, CI=1.06-2.63) • 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

  17. Baltimore Frederick Howard Best Practice Model – Proven Model to Increase Rural Community-based Cancer Trials: Community-Academic-Clinical Partnership CRBaquet, MD, MPH 2007

  18. Allegany Washington Cecil Garrett Kent Queen Anne’s Car - oline Talbot Dorchester Wicomico Worcester Somerset UMSHN Telemedicine/Videoconference Linkages Unique Infrastructure 1. 3. (3) (3) Allegany Allegany Washington Washington (1) Carroll Carroll Cecil Cecil Harford Garrett Garrett Harford Frederick Baltimore Baltimore Balt. Balt. Howard Kent Kent Howard City City (1) UMSHN Offices (13) Montgomery Anne Anne Queen Arundel Arundel Baltimore City Regional Office Eastern Shore Regional Office Anne’s (1) Car - oline Caroline Area Served Area Served Caroline, Cecil, Dorchester, Kent, Queen Anne’s,. Talbot, Somerset, Wicomico and Worcester Counties (2) Talbot Prince Prince Baltimore City Talbot George’s George’s 2. (1) (1) Cal - Charles vert Covered for community & professional health education through NIH P-60 funding Calvert Western Maryland Regional Office SouthernMaryland Regional Office Charles Dorchester Dorchester Wicomico Wicomico Area served St. Mary’s Area Served (2) Garrett County, Allegany County, Washington, and Frederick Counties Calvert, Charles and St. Mary’s Counties St. Mary’s (1) Worcester Worcester Somerset (1) 4. (1) UMSHNOffices 1. Central Office/Baltimore City Office Telemedicine/Videoconference 2. Eastern Shore Regional Office - Salisbury Linkages (32) 3. Western Maryland Regional Office - Hagerstown 4. Southern Maryland Regional Office - Waldorf (#) reflect number of TM/VC linkages CRBaquet, MD, MPH 2007

  19. 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

  20. 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.ASHBESTPRACTICES@LIST.NIH.GOV • CBaquet, MD and MDeShields, MD CRBaquet, MD, MPH 2007

  21. 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 ASHBESTPRACTICES@LIST.NIH.GOV Maryland Community Clinical Trial ProgramSupported by: MSPN/CNP NCI ; MD CRF; Susan G. Komen Foundation Maryland; NIH NCMHD P 60 CRBaquet, MD, MPH 2007

  22. 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

  23. Funding Sources Partnerships supported by funding sources include: • “Maryland Special Populations Cancer Research Network” (grant no. NCI 5CA86249 CBaquet PI) 2000-2005. • 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

  24. 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

More Related