Analyzing National, Institutional, Provider, & Patient Perspectives for Enhancing Minority Participation in Clinical Trials Roundtable on Promotion of Health Equity & the Elimination of Health Disparities Institute of Medicine April 9, 2015 Moon S. Chen, Jr., Ph.D., M.P.H. Associate Director for Cancer Control UC Davis Comprehensive Cancer Center Sacramento, CA
ACKNOWLEDGMENTS The views expressed are those of the presenter and do not necessarily represent the views of the NIH. However, I am grateful for the support provided through the NCI to AANCART (U54 CA153499) and the NIMHD to EMPaCT (U24MD006970). Slides created by: Julie Dang, MPH, CHES
Enhancing Minority Participation in Clinical Trials (EMPaCT) Masonic Cancer Center University of Minnesota, Minneapolis UC Davis Comprehensive Cancer Center, Sacramento Sidney Kimmel Comprehensive Cancer Center Johns Hopkins University, Baltimore University of Alabama Comprehensive Cancer Center, Birmingham M.D. Anderson Cancer Center University of Texas, Houston
Presentation Objectives: Why? Review the Problem & the importance of enhancing minority participation in clinical trials What? Report research on the multi-level Perspectives affecting minority participation in clinical trials. How? Recommend Paradigm that integrates multiple perspectives to mitigate the problem
WHY
Smith B, Smith GL, et al. Future of Cancer Incidence in the United States: Burdens Upon an Aging, Changing Nation. J Clin Oncol 27 by American Society of Clinical Oncology. 2009 Projected Cases of All Invasive Cancers in U.S. by Race & Ethnicity 142% increased incidence for Hispanics of any race 132% increased incidence for Asian/Pacific Islanders 101% increased incidence for multiracial 76% increased incidence for American Indian /Alaska Natives 64% increased incidence for Blacks
NCI Clinical Trials by the Numbers 10,000 NCI Clinical Trials 10,000 <150 83 32 5 4 2,2 1 < 150 focused on racial/ethnic minority Black/African American Hispanic/Latino Asian American Native American American Indian, Alaskan Native Pacific Islander ClinicalTrials.gov, 1/13
Benefits of Clinical Trials transcend therapeutics Patients enrolled in clinical trials receive better care than non-participants. Patients enrolled in clinical trials live longer. Advancing the field is possible when clinical trials that are properly powered are completed. This is particularly relevant to prevention and behavioral research.
Adults vs Children in Clinical Trials ADULTS CHILDREN Black 1.3% 10.4% Hispanic 1.3% 11.6% AIAN 2.5% - API 1.7% - Other - 4.7% TOTAL <5% 60% Chen MS Jr., et al. Twenty years post-nih Revitalization Act: EMPaCT laying the groundwork for improving minority participation in clinical trial accrual. Cancer 2014; 120 (Suppl 7): 1091-6.
Patient MD IRB Personalized Treatment Culture Family Research Patient care What? Perspectives Everyone brings a different perspective and agenda to the table.
Provider s Perspectives Providers are the most influential factor in patient enrollment in clinical trials
Results High Frequency Perceived Barriers to Clinical Trial Participation
Provider-Patient Interactions
Patient s Perspective GENDER AGE EDUCATION DEMOGRAPHICS INSURANCE INCOME VALUES BELIEFS CULTURAL HISTORICAL FEAR & MISTRUST COMMUNICABILITY SOCIAL ALTRUSIM STIGMA
How?
PARADIGM TOOLS TRUSTWORTHINESS TANGIBLE BENEFITS TIME TRUST
Essentials for reducing health disparities Time Understand community issues and concerns Build relationships Outreach and education Trust Ensure community is involved in every step Transparency Culturally appropriate ethnically specific outreach and education Continuous community input and feedback Community ownership
Thousand Asian American Study (TAAS)
DOES THIS WORK? Brown M, Moyer A. Predictors of awareness of clinical trials and feelings about the use of medical information for research in a nationally representative US sample. Ethnic Health. 2010;15:223-226. Tong EK, Fung LC, Stewart SL, Paterniti DA, Dang JHT, Chen MS Jr. Impact of a biospecimen collection seminar on willingness to donate biospecimens among Chinese Americans: Results from a randomized, controlled community-based trial. Cancer Epidemiol Biomarkers, & Prevention 2014 Dang JHT, Rodriguez EM, Luque JS, Erwin DO, Meade CD, Chen MS Jr. Engaging diverse populations about biospecimen donation for cancer research. Journal of Community Genetics 2014 Yes, minorities are willing to participate in health research Yes, TRUST is the key
Tools Educational sessions on clinical trials using a brochure and video. Follow-up with the patients on: discussion with their oncologists regarding clinical trials participation possible enrollment in a trial.
Presentation Objectives: Why? Review the Problem & the importance of enhancing minority participation in clinical trials What? Report research on the multi-level Perspectives affecting minority participation in clinical trials. How? Recommend Paradigm that integrates multiple perspectives to mitigate the problem