Meeting 2017 Engaging Under-represented Minorities to Increase - PowerPoint PPT Presentation

Academy Health ARM 2017 Academy Health Annual Research Meeting 2017 Engaging Under-represented Minorities to Increase Participation in Health Research Sergio Aguilar-Gaxiola, MD, PhD Professor of Clinical Internal Medicine Director, Center for Reducing Health Disparities UC Davis School of Medicine New Orleans, LA June 26, 2017

Treatment Heterogeneity ( from Patient Protection and Affordable Care Act ) “Potential racial, ethnic and other differences in response to [treatments (i.e., drugs, medical devices)] are important to…help ensure that the safety and effectiveness of [interventions] are studied in all people who will use the products once they are approved.” FDA OMH Christine Merenda, M.P.H., R.N. Research shall be designed, as appropriate, to take into account the potential for differences in the effectiveness of health care treatments, services, and items as used with various subpopulations, such as racial and ethnic minorities, women, age, and groups of individuals with different comorbidities, genetic and molecular sub-types, or quality of life preferences and include members of such subpopulations as subjects in the research as feasible and appropriate. 2 Source: Selby, 2013; https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm349063.htm

Academy Health ARM 2017 While there are 230,000 clinical trials in the US (in 2017), only less than 2% of the population participates

Academy Health ARM 2017 Source: https://clinicaltrials.gov/ct2/resources/trends#RegisteredStudiesOverTime

Academy Health ARM 2017 “ It's been 20 years since Congress required that research funded by the U.S. National Institutes of Health (NIH) include minorities, but non-whites still account for less than 5 percent of clinical trial participants, according to a new report. The study from University of California, Davis, Comprehensive Cancer Center also revealed that less than 2 percent of clinical cancer studies focus on people of non- white races or ethnic groups. The findings, published online March 18 in Cancer, revealed that although black people have the highest rates of cancer, Hispanics and blacks have a participation rate of just 1.3 percent in cancer clinical trials.” Source: http://health.usnews.com/health-news/articles/2014/03/21/still-too-few-minority-participants-in-us-clinical-trials-study-finds

Academy Health ARM 2017 Why Is This Important?  Ethically – Social justice requires us to not exclude some populations from participation because of a PI’s or Coordinator’s unconscious or conscious bias as related to retention or wanting only people in your “own practices”  Scientifically – Need to account for genetic, cultural, linguistic, racial/ethnic, gender, and age differences – Need to ensure external validity of findings through a representative sample Source: Modified from Striley, 2013

Academy Health ARM 2017 Who is Commonly Engaged in Clinical Trials Research? Researchers Patients Community at large Source: Modified from Striley, 2013

Academy Health ARM 2017 Often Left Out Researchers Patients Community at large Source: Modified from Striley, 2013

Sentinel Network SENTI SEN TINEL EL NETW ETWORK RK SI SITES TES COMMUNITY PARTNERSHIPS • Albert Einstein College of Medicine • Patient Advocates in Research (PAIR) • University of California-Davis • Community – Campus Partnerships for • University of Florida Health (CCPH) • University of Michigan • University of Rochester • Washington University in St. Louis

Sentinel Network (N=5,979) WUSTL UC Davis Michigan Einstein Rochester TOTAL N=2,253 N=1,030 N=1,049 N=714 N=933 N=5,979 % % % % % % Prior Study 17.8 10.1 25.9 11.3 17.3 17.1 Participation? Interested in 99.7 83.8 86.1 78.5 71.5 87.3 Research? AA Latino Asian Biracial Other White N=3,058 N=1,001 N=341 N=82 N=123 N=1,325 % % % % % % Prior Study 17.4 11.4 4.4 21.0 15.5 21.2 Participation? Interested in 91.0 84.5 79.7 86.3 70.1 85.5 Research? Source: Cottler, L.B., McCloskey, D.J., Aguilar-Gaxiola, S., et al., (2013). Geographic and racial/ethnic differences in community needs, concerns and perceptions about health research: Findings from the CTSA Sentinel Network, American Journal of Public Health , 103(9), 1685-1692.

Would you participate in a research study if you… African- Asian White Hispanic/ Other* American N=341 N=1,325 Latino N=124 N=3,058 N=1,001 % % % % % were only asked about your 87.5 73.9 87.3 82.2 58 health needed to provide access to 77.2 50.9 72.1 69.5 56.9 your medical records had to give a blood sample 82.6 57.2 77.7 75.5 59.4 needed to give a genetic 76.9 51.6 71.8 66.4 54.9 sample *Alaskan Native/Eskimo, American Indian, Middle Eastern, Pacific Islander, Bi-racial and other Source: Cottler, L.B., McCloskey, D.J., Aguilar-Gaxiola, S., et al., (2013). American Journal of Public Health , 103(9), 1685-1692.

Would you participate in a research study if you… African- Asian White Hispanic/ Other* American N=389 N=1919 Latino N=338 N=4313 N=1332 % % % % % had to take medicine 53.0 27.7 48.7 48.4 38.8 had to stay overnight in a 70.5 32.8 60.6 56.4 45.1 hospital had to use medical 75.4 49.6 68.4 63.7 54.9 equipment didn’t get paid 60.1 48.5 67.2 65.9 50.4 *Alaskan Native/Eskimo, American Indian, Middle Eastern, Pacific Islander, Bi-racial and other Source: Cottler, L.B., McCloskey, D.J., Aguilar-Gaxiola, S., et al., (2013). American Journal of Public Health , 103(9), 1685-1692.

Academy Health ARM 2017 Engaging Stakeholders: Recommendations and Lessons Learned  Involve early; more than one stakeholder  Be deliberate in approach: how many, which stakeholder communities, demonstrate value, offer compensation, provide training (for researchers too), adequately prepare, elicit feedback  Clearly define roles and expectations  Engagement is bi-directional; must have mutual benefit, provide opportunities for co-learning Source: Wilkins CH et al. Community Representatives’ Involvement CTSA Activities. Clinical and Translational Science . 2013

Community Engagement Studios • Structured process of eliciting project-specific input • May be used in any phase of translational research • Stakeholders selected based on researchers’ needs • An experienced core team identifies stakeholders and prepares them for engagement; reduces burden to researcher Source: Joosten, et al. (2015). Community Engagement Studios: A Structured Approach to Obtaining Meaningful Input from Stakeholders to Inform Research. Academic Medicine . 2015 Dec; 90(12): 1646 – 1650.

Clinical trial recruitment before and after Community Engagement Studio Before: No participants enrolled After: Targeted enrollment reached ahead of after 3 months of active recruitment schedule; 100% retention in randomized, blinded, placebo controlled trial with 10 study visits Source: Joosten, et al. (2015). Community Engagement Studios: A Structured Approach to Obtaining Meaningful Input from Stakeholders to Inform Research. Academic Medicine . 2015 Dec; 90(12): 1646 – 1650.

Academy Health ARM 2017 “It can be harder to recruit minority populations, but it does not mean Latinos, African Americans and Asians aren’t willing. They may not know of these trials…”

Academy Health ARM 2017 Conclusion  In spite of all the efforts, we are still falling short on involvement of underrepresented minority groups  Underrepresented minorities are willing tp participate in clinical/health research

Academy Health ARM 2017 What’s Next for Research Engagement?  Expand efforts to increase the involvement of under-represented minorities in health research at all levels (e.g., participants of the whole research process)  Continue to engage a variety of beneficiaries of knowledge generated through health research (patients and families, community members, health officials, policy makers, clinicians, health systems, training institutions, purchasers, payers, industry)

Academy Health ARM 2017 “ Go in search of people. Begin with what they know. Build on what they have ” Chinese proverb