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

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MMG

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

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CONFIDENTIAL

Objectives:

What do we know about Hispanics/Latinos and their involvement in clinical research

A real story of a Latina being in clinical research

Why are Hispanics/Latinos not involved in clinical research

How a Hispanic- Latino physician get involved in clinical research

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Objectives:


Background on Hispanics & Latinos in the U.S.

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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

CONFIDENTIAL 1. Census 2010

Hispanics & Latinos are expected to grow to 30 % by 20501

2010 – 16% of the population2020 – 18% of the population2050 – 30% of the population

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2010 2020 20500%5%

10%15%20%25%30%35%Hispanic Population in U.S.

1. U.S. Census 2010

2000-2020 Hispanic/Latino 2nd Generation Dominates Growth2

020406080

100120140

71

45

119

63

100

25

4728 Growth

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•Change in Hispanic Population 2000-2020:

2. Pew Hispanic Center

•35.3 million to 60.4 million

• 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.

Geography of Hispanics & Latinos:

CONFIDENTIAL1. U.S. Census 2010

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.


Economic Challenges for Hispanics & Latinos

1 in 4 U.S. Hispanics lives in poverty, and 1 in 5 under 18 years of age live in poverty. 1

Many Hispanics hold down >1 job. It is difficult for them to make the necessary appointments for clinical trial for fear of losing their job.

The most vulnerable age groups: U.S. Hispanic children & elderly, of whom 33.1 % & 18.3% live below the poverty line respectively.1

Caring for children and the elderly is culturally important for Hispanics & Latinos; therefore, engaging in a trial presents another time challenge to participate in a trial.


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

CONFIDENTIAL3. Evelyn, 2001

4.Gonzalez et al 2010

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

CONFIDENTIAL5. iccnetwork.org 2010

6. Barreau 2010

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 Hispanics visited 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

CONFIDENTIAL www.farmasc.com

7. Centers for Disease8.Chui-Lin et al, June, 2007

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

CONFIDENTIAL www.farmasc.com

9. Respiratory Medicine, 2006

10. Chest, 2003

What does this all mean?

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11. hhs.gov/oirm/infocollect/nclusion.html

www.farmasc.com

Industry is behind representing

Hispanics/Latinos in trials

Physicians are asking for more data around

Hispanics & Latinos to feel more comfortable

to Rx

FDA encourages sponsors to collect the data in accordance with

OMB for race and ethnicity categories

when developing their study protocols11

Hispanics & Latinos need more appropriate

health options

http://www.hhs.gov/oirm/infocollect/nclusion.html

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Objectives:



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

CONFIDENTIAL 12. Interview 2010

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 “Americanos blancos,”

she hopes we can have more Hispanics & Latinos in trials to see how they respond differently to medications

CONFIDENTIAL12. Interview 2010

CONFIDENTIAL

Objectives:



Why are Hispanic- Latinos not involved in clinical research

Todos Juntos por la Salud Forum February 2011 Preview of findings

around WHY low research participation

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Key issues as to lack of Hispanic-Latino participation in trials13

• Lack of awareness– Patient level– Physician level– Community level– Access to research– Access to funding

• Lack of training– Principal Investigator training– HCPs– Nurses– Community

• 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

CONFIDENTIAL13. Findings, MMG

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.


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


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 Todos Juntos 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


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


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.

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• 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

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.

14. Rayo, 2010

www.farmasc.com

Hispanic oriented VW cc ad filmed in Mexico 2008

CONFIDENTIAL15. www.youtube.com/watch?v=K-0FHgMuOi0

http://www.youtube.com/watch?v=K-0FHgMuOi0

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Objectives:


A real story of being in clinical research

Why are Hispanic- Latinos not involved in clinical research

How a Hispanic- Latino physician get involved in clinical research

How to become a Principal Investigator as a community based physician

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What six key steps do you need to take?

1. Know the regulations2. Have your site inspected3. Get IRB approval4. Sign a Contract5. Prepare for a site Initial Visit6. Build your network

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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

CONFIDENTIAL16. ClinicalTrials.com 2010

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


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.


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.


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


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.


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

CONFIDENTIAL17. CenterWatch.com, Clinicaltrials.gov, myclin.com

http://www.centerwatch.com/

http://www.clinicaltrials.gov/

http://www.myclin.com/

Summary points:

CONFIDENTIAL

Hispanics & Latinos are a growing population and major force in the U.S.

market

Hispanics & Latinos have unmet medical needs and represent a key component

in clinical trials

There are unique barriers that limit their participation in

clinical trials

Appropriate outreach will increase Hispanic/Latino

participation into trials

MMG can help implement such a program

QUESTIONS & COMMENTS?

Sara Tylosky John [email protected] [email protected] Tel: 561-744-9304 Tel: 240-747-1719

CONFIDENTIAL

Thank you for your time Gracias por su tiempo

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

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