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Clinical Trials:Hispanic P ti i tiHi     i Participation    A Novel Approach to             pp       Recruitment          ...
Minority Participation in Clinical Research        Why is industry lagging?
US 2010 C           Census: 2050 P j ti                        Projection                US Demographic Projection       7...
Hispanic Initiatives  Hi    i I iti tiAdministrative Body Edicts NIH Revitalization Act, 1993   US Congressional Mandate 2...
Forest Clinical Trial Data: 2010       F    t Cli i l T i l D t                      Demographic Actual v. US Population  ...
Farma Consulting International        F     C    lti I t      ti   lBottom-up Approach to Patient Recruitment     Aim to m...
Targeted Approach to Patients     T    t dA       h t P ti t     Socioeconomic Profiling       Culture       Language     ...
Touch Points for OutreachT   hP i t f O t        h
US Hi   Hispanic Population by State         i P    l ti b St t
Targeted Information ElucidationT    t dI f     ti El id tiTraditional Questionnaire:structured, open ended, interview–gui...
Farma Focus Gro p Results      Foc s Group Res lts   Potential   Potential   Hispanic   Hispanic   Hi     i   Patients   P...
“Clinical T i l   “Cli i l Trials are Dangerous”                       D        ”Clinical trials are more closelyregulated...
Farma Focus Gro p Results      Foc s Group Res lts   Potential      p   Hispanic   Patients    “Trials are    dangerous”  ...
“Primary Care – ER & W lk i ”    “P i     C           Walk-in”Dallas Focus Groups (Health fair attendees)                 ...
Healthcare Providers:      Underserved PatientsCommunity clinic in the ‘Barrio’ in San AntonioFamily Pharmacy at medical p...
Farma Focus Gro p Results      Foc s Group Res lts   Potential      p   Hispanic   Patients    “Trials are     “COPD? No b...
“COPD? – N b         No breathless!”                thl   !”                 ¿Fumas o Fumabas? ¿Ti                 ¿F     ...
Farma Focus Gro p Results      Foc s Group Res lts                        “Can’t afford to   Potential             get the...
“What’s i    “Wh t’ in it for Me?”                 f M ?”                             Variable       Site Zip   Catchment ...
“What’s i  “Wh t’ in it for Me?”               f M ?”Without patients there will be no clinical trials  Patients should no...
Physician O t  Ph i i Outreach                h                                     MAHPA SymposiumHispanic Physicians:   ...
Hispanic Participation – Bottom Line  1. Traditional methods not very     successful  2.  2 Outreach has to be targeted  3...
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Hispanic Patients: An Underrepresented Ethnic Minority in Clinical Research - Colin Scott, Forest Research Institute Inc.

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Colin Scott, Forest Research Institute Inc. - Speaker at the marcus evans Evolution Summit, held in Wheeling, IL, April 30 - May 2, 2012 delivered his presentation on the topic Hispanic Patients: An Underrepresented Ethnic Minority in Clinical Research

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Transcript of "Hispanic Patients: An Underrepresented Ethnic Minority in Clinical Research - Colin Scott, Forest Research Institute Inc."

  1. 1. Clinical Trials:Hispanic P ti i tiHi i Participation A Novel Approach to pp Recruitment Colin Scott, MD Senior Director – Respiratory Forest Research Institute
  2. 2. Minority Participation in Clinical Research Why is industry lagging?
  3. 3. US 2010 C Census: 2050 P j ti Projection US Demographic Projection 70 60 50 16% 30% 40 2010 % 30 2050 20 10 0 Am rican Asian H panic H anic can hite on- on- Afric ispa h no isp A er o W N Only the Hispanic population showssignificant growth in proportional share
  4. 4. Hispanic Initiatives Hi i I iti tiAdministrative Body Edicts NIH Revitalization Act, 1993 US Congressional Mandate 2001: clinical trials sufficient to elicit information of ethnic groups Office of Management and Budget: Policy Directive 15, 1997 Recommendations for the collection of race and ethnicity data FDA Guidance for Industry, 2005 Collection of Race and Ethnicity Data in Clinical Trials: differences have been observed in ethnically distinct subgroups attributable to intrinsic or extrinsic factors.
  5. 5. Forest Clinical Trial Data: 2010 F t Cli i l T i l D t Demographic Actual v. US Population 100 80 60 4% v. 16% Forest % 40 US Δ 75% Δ 50% 20 0 White Whit non- Hispanic Hi i African Af i Other Oth Hispanic American Non-HispanicTrial Participant: middle class, non-Hispanic, white
  6. 6. Farma Consulting International F C lti I t ti lBottom-up Approach to Patient Recruitment Aim to match patients to sites www.farmasc.com
  7. 7. Targeted Approach to Patients T t dA h t P ti t Socioeconomic Profiling Culture Language Location Economic status Educational statusUse profile to develop a targeted outreach
  8. 8. Touch Points for OutreachT hP i t f O t h
  9. 9. US Hi Hispanic Population by State i P l ti b St t
  10. 10. Targeted Information ElucidationT t dI f ti El id tiTraditional Questionnaire:structured, open ended, interview–guidedNodora J. et al HEALTH 2 (2010)742-752 Fat Tony says “it gotta be gaffed”“Know about clinical trials and Know are willing to participate” Targeted Questionnaire: specific, closed questions, spontaneous Communication, Farma Consulting: data on file 2011 “What’s in it for me?” “Well, he would, wouldn’t he?”
  11. 11. Farma Focus Gro p Results Foc s Group Res lts Potential Potential Hispanic Hispanic Hi i Patients Patients “Trials are dangerous” d ”
  12. 12. “Clinical T i l “Cli i l Trials are Dangerous” D ”Clinical trials are more closelyregulated than clinical practicePotential Benefits (per FDA.gov)• Active involvement in healthcare• Access to new treatments• Expert medical care F. Ross• Help others by contributing to medical research JohnsonActual Benefits “BGO” BGO• Free intensive healthcare- insurance not needed• Free drug – (placebo fallacy)• Extensive diagnostic panel• Feel better
  13. 13. Farma Focus Gro p Results Foc s Group Res lts Potential p Hispanic Patients “Trials are dangerous” d ” “Primary care = ER”
  14. 14. “Primary Care – ER & W lk i ” “P i C Walk-in”Dallas Focus Groups (Health fair attendees) p )61% reported having a Primary Care Physician50% used ER or walk-in clinic as their primary care giver6% used a faith healer28% haven’t had need of primary careThreat hPCP bad source for clinical trial informationOpportunityO t itReduce the burden of care in ER and walk-in clinics
  15. 15. Healthcare Providers: Underserved PatientsCommunity clinic in the ‘Barrio’ in San AntonioFamily Pharmacy at medical plaza in San Antonio
  16. 16. Farma Focus Gro p Results Foc s Group Res lts Potential p Hispanic Patients “Trials are “COPD? No breathless” dangerous” d ” “Primary care = ER”
  17. 17. “COPD? – N b No breathless!” thl !” ¿Fumas o Fumabas? ¿Ti ¿F F b ? ¿Tienes problemas para respirar? ¿Tienes 40 años o más? Estudio de investigación clínica p g para g gente con problemas respiratorios. Podrías recibir compensación. No se necesita seguro. Llámanos al 1-866-788-3690 xxx xxxx KISS Principle
  18. 18. Farma Focus Gro p Results Foc s Group Res lts “Can’t afford to Potential get there and Hispanic what’s i i for h ’ in it f Patients me if I do?” “Trials are “COPD? No breathless” dangerous” d ” “Primary care = ER”
  19. 19. “What’s i “Wh t’ in it for Me?” f M ?” Variable Site Zip Catchment Zip Percent Hispanic 48% 91% Ave. Household $32,952 $20,117 Site IncomeCatchment Households 15.4% 36.3% Below Poverty Advanced Degree 51.3% 13.4% Holders San Antonio, TX
  20. 20. “What’s i “Wh t’ in it for Me?” f M ?”Without patients there will be no clinical trials Patients should not be Visit costs should be paid toexpected to incur any cost the patients after each visitattendant on participation p p as a motivator for retention in a clinical trial
  21. 21. Physician O t Ph i i Outreach h MAHPA SymposiumHispanic Physicians: Less involved in drug studies Less sure about safety Have less patients asking about drug studiesOutreach: Symposia PI training Sub-investigator status Pro-bono benefit of referral
  22. 22. Hispanic Participation – Bottom Line 1. Traditional methods not very successful 2. 2 Outreach has to be targeted 3. Tailor outreach to specific patient needs • Reach out at community level • Explain benefit • Pay up-frontWe measure success one patient at a time
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