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

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

Academy Health ARM 2017

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

• f 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.

Treatment Heterogeneity

(from Patient Protection and Affordable Care Act)

2

Source: Selby, 2013; https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm349063.htm

“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.

While there are 230,000 clinical trials in the US (in 2017),

• nly less than 2% of the population participates

Academy Health ARM 2017

Academy Health ARM 2017

Source: https://clinicaltrials.gov/ct2/resources/trends#RegisteredStudiesOverTime

Academy Health ARM 2017

Source: http://health.usnews.com/health-news/articles/2014/03/21/still-too-few-minority-participants-in-us-clinical-trials-study-finds

“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

• f cancer, Hispanics and blacks have a participation rate of

just 1.3 percent in cancer clinical trials.”

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

Academy Health ARM 2017

Source: Modified from Striley, 2013

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

Academy Health ARM 2017

SEN SENTI TINEL EL NETW ETWORK RK SI SITES TES

• Albert Einstein College of Medicine
• University of California-Davis
• University of Florida
• University of Michigan
• University of Rochester
• Washington University in St. Louis

COMMUNITY PARTNERSHIPS

• Patient Advocates in Research (PAIR)
• Community–Campus Partnerships for

Health (CCPH)

Sentinel Network

Sentinel Network (N=5,979)

WUSTL N=2,253 % UC Davis N=1,030 % Michigan N=1,049 % Einstein N=714 % Rochester N=933 % TOTAL N=5,979 % Prior Study Participation? 17.8 10.1 25.9 11.3 17.3 17.1 Interested in Research? 99.7 83.8 86.1 78.5 71.5 87.3

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.

AA N=3,058 % Latino N=1,001 % Asian N=341 % Biracial N=82 % Other N=123 % White N=1,325 % Prior Study Participation? 17.4 11.4 4.4 21.0 15.5 21.2 Interested in Research? 91.0 84.5 79.7 86.3 70.1 85.5

Would you participate in a research study if you…

African- American N=3,058 % Asian N=341 % White N=1,325 % Hispanic/ Latino N=1,001 % Other* N=124 % were only asked about your health 87.5 73.9 87.3 82.2 58 needed to provide access to your medical records 77.2 50.9 72.1 69.5 56.9 had to give a blood sample 82.6 57.2 77.7 75.5 59.4 needed to give a genetic sample 76.9 51.6 71.8 66.4 54.9

*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- American N=4313 % Asian N=389 % White N=1919 % Hispanic/ Latino N=1332 % Other* N=338 % had to take medicine 53.0 27.7 48.7 48.4 38.8 had to stay overnight in a hospital 70.5 32.8 60.6 56.4 45.1 had to use medical equipment 75.4 49.6 68.4 63.7 54.9 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.

Engaging Stakeholders: Recommendations and Lessons Learned

 Involve early; more than one stakeholder  Be deliberate in approach: how many, which

stakeholder communities, demonstrate value,

• ffer 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

Academy Health ARM 2017

• 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

Community Engagement Studios

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.

Before: No participants enrolled after 3 months of active recruitment

Clinical trial recruitment before and after Community Engagement Studio

After: Targeted enrollment reached ahead of 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

 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

Conclusion

Academy Health ARM 2017

 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)

What’s Next for Research Engagement?

“Go in search of people. Begin with what they know. Build on what they have”

Chinese proverb

Academy Health ARM 2017