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Multiculturalism and Clinical
Trials
Lisa Valtierra
lisa@valtierraconsulting.com
Disclaimer
This presentation represents my opinions, and my opinions only.
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
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
Why not change it up?
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
We need a different approach
• Let’s start with
• More compassion
• More connection
• More cultural understanding
• We need a more human approach
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
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
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
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

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Scope valtierra 2016

  • 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