Diversity in clinical trials is important - we can and must improve participation minority patients for a better understanding of diseases, their treatments and outcomes.

1. Multiculturalism and Clinical
Trials
Lisa Valtierra
lisa@valtierraconsulting.com

2. Disclaimer
This presentation represents my opinions, and my opinions only.

3. Three things that matter
• Demographics have shifted
• Latinos are 18% of US population
• Latinos will be 30% of the US population by 2050
• Asians are 5% - 6% and will continue to grow
• African Americans are 12% of US population and will remain stable
• Minorities bear a disproportionate burden of chronic diseases* including:
• Cancer
• Heart disease
• Type 2 Diabetes
• Minorities are underrepresented in clinical trials
• Less than 5% of clinical trial participants**
• Lack of data among these populations limits understanding of drug efficacy
*Centers for Disease Control and Prevention, Division for Heart Disease and Stroke Prevention, Fact Sheets and At-A-Glance
Reports
**US News & World Report March 2014

4. Why does it matter?
• Incompletely filled trials cost time and money
• Not enough data, leads to the inability to show:
• Ethnic differences
• Gender differences
• Which may lead to:
• Possible FDA approval delays or denial
• Marketing limitations
• Persistent inequality of healthcare

5. Why not change it up?

6. Old habits die hard…
• Recruiting efforts geared towards one group
• Most clinical trials include an overwhelming majority of white men
• Clinical trial sites tend not to vary
• We have blamed cultural differences for lack of patients’ participation
in clinical trials
• But have we asked, “Why?”
• Mistrust of medical establishment exists, but can be addressed
• No one asks
• We need to stop doing things the way they have always been done

7. We need a different approach
• Let’s start with
• More compassion
• More connection
• More cultural understanding
• We need a more human approach

8. So, what can we do differently?
• Nordstrom experience with 7-11 convenience
• Choose sites that are convenient for participants
• Provide translated consent forms
• Exceed expectations of clear communication
• Discover what is important to patients
• Ensure participants feel appreciated

9. We have opportunities
• Engage advocacy organizations for input
• Engage communities at a more local level
• Discover what’s important, challenging to patients and their families
• Discover what’s important, challenging to clinicians
• Use technology to everyone’s advantage
• Use data to better understand cultural nuances
• Understand differences in health care barriers, motivators, emotional drivers
• Use technology to better communicate with participants

10. What can happen?
• Better (appropriate) representation of minorities in clinical trials
• More fully enrolled and retained patient base
• Reduced loss to follow up
• Data that is representative of disease prevalence
• Money well spent

11. Why it all matters
• People’s health depends on this process
• You, your mother, father, sister, brother, aunt, uncle, cousin, son, daughter,
friend
• We have the responsibility and the opportunity to do good and do
well