1 / 42

The Whats , Whys and Hows of Hispanics & Latinos’ involvement in Clinical Research

The Whats , Whys and Hows of Hispanics & Latinos’ involvement in Clinical Research. Sara Tylosky MMG. MMG. A global full-service patient recruitment and retention group that develops strategies to accelerate patient enrollment, achieve participant retention goals in clinical research.

beau
Download Presentation

The Whats , Whys and Hows of Hispanics & Latinos’ involvement in Clinical Research

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. CONFIDENTIAL The Whats, Whys and Howsof Hispanics & Latinos’ involvement in Clinical Research Sara Tylosky MMG

  2. CONFIDENTIAL MMG A global full-service patient recruitment and retention group that develops strategies to accelerate patient enrollment, achieve participant retention goals in clinical research

  3. Objectives: • How a Hispanic- Latino physician get involved in clinical research CONFIDENTIAL

  4. Objectives: CONFIDENTIAL

  5. Background on Hispanics & Latinos in the U.S. CONFIDENTIAL

  6. CONFIDENTIAL Hispanics/Latinos are the dominant force in the U.S.1 • 16 percent of the U.S. population • Americans of this descent - 2nd largest population group • Youngest demographic group, with a median age of 27.4 years versus 36.8 years in the general population • The United States has 2nd largest Hispanic/Latino population worldwide 1. Census 2010

  7. CONFIDENTIAL Hispanics & Latinos are expected to grow to 30 % by 20501 2010 – 16% of the population 2020 – 18% of the population 2050 – 30% of the population 1. U.S. Census 2010

  8. CONFIDENTIAL 2000-2020 Hispanic/Latino 2nd Generation Dominates Growth2 • Change in Hispanic Population 2000-2020: • 35.3 million to 60.4 million 2. Pew Hispanic Center

  9. CONFIDENTIAL Geography of Hispanics & Latinos: • California & Texas: 47% have of the Hispanic-origin population with 13.7 million 9.1 million Hispanics respectively1 • These two states are KEY geographies for Hispanic & Latino recruitment success. 1. U.S. Census 2010

  10. CONFIDENTIAL Geography of Hispanics & Latinos:1 • 16 states with at least ½ -million Hispanic residents. • 46 %of New Mexico's population in 2009 was Hispanic, the highest of any state. • Between 2008 & 2009, a 6.6 % increase in the Hispanic population in Alabama (highest increase). • These states represent another layer of geographic opportunity to target Hispanic & Latino recruitment. 1. U.S. Census 2010

  11. CONFIDENTIAL Economic Challenges for Hispanics & Latinos 1. U.S. Census 2010

  12. CONFIDENTIAL Yet, Hispanics/Latinos are Underrepresented in U.S. Clinical Trials Relative to their Population • 1995-1999: only 3% of clinical trial participants were Hispanic or Latinos3 • 1996-2002: 3.1% of clinical trail participants for breast, lung, colorectal, and prostate cancers were Hispanic or Latino4 3. Evelyn, 2001 4.Gonzalez et al 2010

  13. CONFIDENTIAL Hispanics/Latinos are Underrepresented in U.S. Clinical Trials Relative to their Population • From 2003-2005, overall Hispanic/Latino participation of the National Cancer Institute funded cancer clinical trial was 5.6%5 • As of 2009, minorities participating in clinical trials have remained lower than Caucasian participation relative to their demographics6 5. iccnetwork.org 2010 6. Barreau 2010

  14. CONFIDENTIAL www.farmasc.com Even in a disease – COPD, where there is under treatment of Hispanics/Latinos • Hispanics /Latinos have lower prevalence & death rates for both chronic bronchitis and emphysema compared to Caucasians7 • YET, access to quality healthcare & lack of proper diagnosis remains a huge obstacle for Hispanics who suffer from COPD. 8 • A study of COPD patients found that Hispanicsvisited the emergency room at twice the rate of Caucasian patients.8 • This suggests that even though fewer Hispanics suffer from COPD, low access to healthcare may prevent them from receiving the routine treatment they need to control their COPD8 7. Centers for Disease 8.Chui-Lin et al, June, 2007

  15. CONFIDENTIAL www.farmasc.com Even in a disease – COPD, where there is under treatment of Hispanics/Latinos • Mexican American elders have similar severities of COPD despite less tobacco exposure than European American elders and Mexican Americans represent 67% of the Hispanics & Latinos population9 • Hispanic patients with COPD have more problems receiving optimal care compared to patients of other racial groups10 9. Respiratory Medicine, 2006 10. Chest, 2003

  16. CONFIDENTIAL What does this all mean? 11. hhs.gov/oirm/infocollect/nclusion.html www.farmasc.com

  17. Objectives: CONFIDENTIAL

  18. CONFIDENTIAL The real story of Gabriela, one Hispanic/Latina12 • Gabriela, a 45 year old Latina, developed HIV from her husband from an extramarital relationship in 1994 • Through her husband, she also passed on HIV on to her daughter. • Both Gabriela’s husband and daughter died within a two years of confirmation from HIV complications • The next 2 years, Gabriela suffered from: • anger, • depression, • frustration, • confusion & sense of helplessness, • and her health suffered. • She decided to give up her other 2 children for adoption as she felt incapable of taking care of them 12. Interview 2010

  19. CONFIDENTIAL The real story of Gabriela, one Hispanic/Latina12 • Eventually Gabriela ended up in the E.R. due to complications of: • tuberculosis, pneumonia, herpes, mouth infection and eventually Hepatitis C and Parkinson’s • After 5 years of psychological therapy and joining a support group, she joined a trial in 2000 & has been in studies (via NIH) ever since. • 15 years later, Gabriela is now the spokesperson to help other Latinas seek options to better understand their medical condition and circumstances by learning about themselves, their health and clinical trials, called LUNA • Her one son is back living with her, taking care of her • Since most studies have been with “Americanosblancos,” she hopes we can have more Hispanics & Latinos in trials to see how they respond differently to medications 12. Interview 2010

  20. Objectives: CONFIDENTIAL

  21. TodosJuntospor la Salud Forum February 2011 Preview of findings around WHY low research participation CONFIDENTIAL

  22. Key issues as to lack of Hispanic-Latino participation in trials13 Lack of a clear message Benefits of clinical research Bring stakeholders together Identify target for message Mistrust & misconceptions Stigma of certain diseases “White” and/or not culturally competent staff Language & culture Lack of relationships • Lack of awareness • Patient level • Physician level • Community level • Access to research • Access to funding • Lack of training • Principal Investigator training • HCPs • Nurses • Community CONFIDENTIAL 13. Findings, MMG

  23. Phase I – Develop the story about clinical research13 • Define the story: what is clinical research in the U.S. (Phase 1-IV) & what does that mean for an individual patient and/or family member in lay terms • Discuss Stigmas • Use real people via media to share stories and successes about research • Create access tools like CBO ambassadors, online media to disseminate to communities to breakdown barriers of specific diseases, e.g., mental disorders, HIV, HCV, etc. • Tools like CISCRP and other CBOs that deal in certain diseases (AHA, ACS, etc.) • Share benefits of being in clinical research • How research helps future generations to come • Can provide treatment options to disease or condition • Be in Support groups that exist around disease (e.g., LUNA, PACT) • Risk/benefit, payment for volunteer participation in trial, etc. CONFIDENTIAL 13. Findings, MMG

  24. Phase II – Identify groups to share story and educate13 • Identify Stakeholders • Pharmas/Biotechs • PIs, HCPs, Nursing staff, CBOs, patient groups • Key Hispanic/Latino Health Advocacy groups • Hospital associations, Community centers, “hotspots” of care, safety nets, waiting rooms = educational centers • Nursing groups • People that touch research • Corporations interested in Hispanic/Latino Health (e.g., Walmart pharmacies, etc.) • Other CBOs (Community Based Organizations) • Patient groups CONFIDENTIAL 13. Findings, MMG

  25. Phase III – Educate & Train • Develop relationships between healthcare and patient community • Create partnerships between Pharma industry, “hotspot” healthcare communities and CBOS • Fund through Pharmas/Biotechs Large Healthcare research advocacy groups interested in tapping into Hispanic/Latino market (e.g., AHA, ACS, etc.) • Create educational venues at all levels create better awareness • Forums & campaigns like TodosJuntos broken down into groups/regions, etc. • P.I. training for Hispanic/Latino HCP • Training at Hispanic/Latino nursing groups • Include cultural competency training • Includes relationship building, spiritual awareness, gender issues, language • Simple language for patient • Includes overview of the subtle differences between sub groups CONFIDENTIAL 13. Findings, MMG

  26. Phase IV – Bring the resources together13 • Develop feedback database where learning has occurred • Monitor the media to update trainings/findings • Create new relationships between healthcare and patient community for research opportunities • Develop tangible research projects based on new medications coming into the marketplace CONFIDENTIAL 13. Findings, MMG

  27. CONFIDENTIAL Example of Language & Cultural Competency of Hispanics & Latinos14 • Differences: A grandmother from Puerto Rico in New York City vs. single Mexican man living in rural Texas vs. a 2nd-generation Cuban student living in Miami. • Beyond Spanish. 55% of Hispanics have Spanish as dominant language. 21% speak English most of the time and 13% speak only English. YES SI OUI • 14. Rayo, 2010

  28. Example of Language & Cultural Competency of Hispanics & Latinos14 • Focus on the cultural connections. Connect with their cultural traditions-roots in the family or in food. • Give them something to do. 73% of Hispanics & Latinos more likely to engage when equipped to become active. • Remember that a little goes a long way. Create a message with 1-2 seconds of a Spanish-language which can resonate such as the VW ads recently viewed on TV. www.farmasc.com • 14. Rayo, 2010

  29. Hispanic oriented VW cc ad filmed in Mexico 2008 CONFIDENTIAL • 15. www.youtube.com/watch?v=K-0FHgMuOi0

  30. Objectives: CONFIDENTIAL

  31. How to become a Principal Investigator as a community based physician CONFIDENTIAL

  32. CONFIDENTIAL What six key steps do you need to take? • Know the regulations • Have your site inspected • Get IRB approval • Sign a Contract • Prepare for a site Initial Visit • Build your network

  33. CONFIDENTIAL 1. Know the regulations-Good Clinical Practices (GCP)16 • GCP • International ethical and scientific quality standard for the design, conduct, recording and reporting of clinical trials that involve the participation of human subjects • Compliance with this standard provides public assurance that the rights, safety and wellbeing of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data and reported results of clinical investigations are credible and accurate • GCP training available through many online sources • 16. ClinicalTrials.com 2010

  34. CONFIDENTIAL 1. Know the regulations –Key Federal Codes16 • Regulations which define what is required by the US FDA and covers the responsibilities of sponsors, investigators, and Institutional Review Board (IRB) • 21 Code of Federal Regulation (CFR) Part 50 Protection of Human Subjects • 21 CFR Part 54 – Financial Disclosure by Clinical Investigators • 21 CFR Part 56 – Institutional Review Boards (IRBs • 21 CFR Part 312 – Investigational New Drug Application 16. ClinicalTrials.com 2010

  35. CONFIDENTIAL 2. Have your site inspected16 • A clinical research associate (CRA) who represents the sponsor will conduct a pre-study site visit at your site to evaluate your experience, expertise and interest as well as your staff, facility and potential patient population available for the clinical trial. 16. ClinicalTrials.com 2010

  36. CONFIDENTIAL 3. Get IRB approval16 • Get IRB approval. An institutional review board (IRB) is a group designated to protect the rights, safety and well-being of patients involved in a clinical trial by reviewing all aspects of the trial and approving its startup. You will be required to obtain IRB approval for the study at your site. 16. ClinicalTrials.com 2010

  37. CONFIDENTIAL 4. Sign a Contract16 • A contract between you and the sponsor or a CRO needs to be signed before the clinical trial starts. The document usually contains your responsibilities, including the number of subjects you are expected to enroll, timelines for enrollment and the regulatory requirements. It also includes the sponsor’s responsibilities, including financial compensation and how it will be paid. Most sponsors follow a fee-for-service model, meaning they pay for actual work performed, such as subjects enrolled and subject visits 16. ClinicalTrials.com 2010

  38. CONFIDENTIAL 5. Prepare for a site Initial Visit16 • A CRA will conduct a site initiation visit (SIV) after the IRB has given its approval and the contract and all essential documents have been completed. The purpose of this visit is to assure that everything is in place for you to begin enrolling patients. 16. ClinicalTrials.com 2010

  39. CONFIDENTIAL 6. Build your knowledge network17 • Cultural competency training • www.CenterWatch.com and www.Clinicaltrials.gov are two websites that list thousands of trials to get connected • Check out websites of other pharma/biotech companies within a certain disease • MyClin is a unique online communication, information and management tool for all participants in FDA regulated trials www.myclin.com • Build relationships through conferences, forums, summits like this and others 17. CenterWatch.com, Clinicaltrials.gov, myclin.com

  40. CONFIDENTIAL Summary points:

  41. QUESTIONS & comments?

  42. Thank you for your time Gracias porsutiempo Sara Tylosky John Benbrook stylosky@mmgct.com jbenbrook@mmgct.com Tel: 561-744-9304 Tel: 240-747-1719 CONFIDENTIAL

More Related