TransCelerate Better Practices Trial Diversification Better Practices Topic 6: Community Engagement...
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Clinical Trial Diversification Better Practices Topic 6: Community Engagement Kit for Sites These materials were first completed on 10-April, 2015 These materials were last updated on 8-May, 2015 Version 1.1 Disclaimer: The contents of this file are not tailored to any particular factual situation and are provided “as is” without warranty of any kind, express or implied, including but not limited to fitness for a particular purpose. Neither TransCelerate, any of its Members, nor any of their employees accept any responsibility for any loss of any kind including loss of revenue, business, anticipated savings or profits, loss of goodwill or data or for any indirect consequential loss whatsoever to any person using the Change Management Tools or acting or refraining from action as a result of the information contained in the Change Management Tools. TransCelerate and its Members reserve the right to use the Change Management Tools for their own purposes without restriction. Nothing in this presentation should be construed as legal advice, nor does anything in this presentation imply or warrant that use of this approach complies with applicable laws or regulations. Users implement the approach outlined in this presentation at their own risk, and bear the sole responsibility for ensuring their compliance with applicable laws and regulations in their respective jurisdictions.
Transcript of TransCelerate Better Practices Trial Diversification Better Practices Topic 6: Community Engagement...
Clinical Trial Diversification Better PracticesTopic 6: Community Engagement Kit for SitesThese materials were first completed on 10-April, 2015
These materials were last updated on 8-May, 2015
Version 1.1Disclaimer: The contents of this file are not tailored to any particular factual situation and are provided “as is” without warranty of any kind, express or
implied, including but not limited to fitness for a particular purpose. Neither TransCelerate, any of its Members, nor any of their employees accept any
responsibility for any loss of any kind including loss of revenue, business, anticipated savings or profits, loss of goodwill or data or for any indirect
consequential loss whatsoever to any person using the Change Management Tools or acting or refraining from action as a result of the information
contained in the Change Management Tools. TransCelerate and its Members reserve the right to use the Change Management Tools for their own
purposes without restriction. Nothing in this presentation should be construed as legal advice, nor does anything in this presentation imply or warrant
that use of this approach complies with applicable laws or regulations. Users implement the approach outlined in this presentation at their own risk,
and bear the sole responsibility for ensuring their compliance with applicable laws and regulations in their respective jurisdictions.
Clinical trials face increasing pressure to ensure clinical trial populations reflect the disease state
Regulatory / Political
Scientific
Commercial
Social Responsibility
In the US, traditional minority populations are growing rapidly and
expected to become the majority
Regulators are increasingly focused on ensuring trial populations
are representative of the indicated population
The standard practice of generalizing scientific conclusions is
challenged by the demand for personalized medicine
Broad recognition of the need to develop drugs with all patients in
mind
• Current FDA guidance[1] states:
“Although FDA has long requested race and ethnicity data on subjects in certain clinical trials, the Agency has not
previously made explicit recommendations on the categories to use when collecting and reporting the data”
• However, minority populations generally remain under-represented in clinical trial populations[2]
African Americans represent 12% of the U.S. population but only 5% of clinical trial participants
Hispanics represent 16% of the U.S. population but only 1% of clinical trial participants
Changing pressures to ensure representative diversity in clinical trial populations:
[1] FDA Guidance for Industry Collection of Race and Ethnicity Data in Clinical Trials (available at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126396.pdf). Accessed Mar 3,
2015
[2] FDA Consumer updates: Clinical Trials Shed Light on Minority Health (Available at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm349063.htm). Accessed Feb 15, 20151
A broad range of patient participation barriers limit the ability to achieve representative diversity
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SponsorSite /
Investigator / Physician
Patient
Societal / environmental compounding
factors
Barriers to clinical trial recruitment:
Clinical Trial Participation Barriers originate from multiple sources
Illustrative examples:
• Limited understanding of
what the patient wants or
needs to participate
• Low willingness to work
with research naïve
sites/investigators
• Practical obstacles to
participation
• Lack of trust in pharma and
medical research
• Low health literacy /
language barriers
• Lack of awareness of trials
• Lack of minority
investigators and research
staff
• Site start up costs are
expensive
• Lack of referral to trials
• Lack of community
engagement
• Qualified subjects are not
always offered the
opportunity to Participate
• Research naive sites are
over looked despite having
clinical trial potential
Objectives and Target Audience
• The objectives of the following contents are to provide sites used by sponsor organizations with tools to recruit minority populations by engaging with local community organizations.
• Content provided in this presentation is intended for staff at sites. These materials should therefore be shared with anyone responsible for engaging with or supporting sites, including Site Managers, Site Monitors and Site Liaisons
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Engaging the local community can help reduce the participation barriers and enable minority recruitment
Community Engagement is intended to build relationships between the practice and the community:
– Increasing patient knowledge and awareness about clinical trials
– Overcoming patient mistrust of pharma and medical research
– Building a rapport between practices and the communities they serve
Community Engagement Toolkit provides a simple step-by-step process for sites to:
– Identify community leaders , members and organizations to better engage with their community
– Raise awareness of and provide access to clinical trials
– Educate and support the communities they serve
Contents of the toolkit include:
– Approach for engaging community leaders, members and organizations
– Templates for initiating contact with leaders, members and organizations
– Tactics for maintaining relationships with community leaders, members and organizations
– Example lists of community organizations
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4 Steps to Community Engagement
Explore Connect Assess Maintain
• Understand
community needs
and health issues
• Identify appropriate
community leaders,
members and
organizations
• Contact and
engage community
leaders, members
and organizations
STEPS:
• Identify and assess
areas of common
needs and
collaboration
opportunities
• Build a rapport
• Stay connected
• Share information
• Provide feedback
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Step 1 - ExploreFact Finding Mission
Understand community needs and health issues
– Be mindful of the demographic make-up of local communities
– Understand the health challenges facing local communities
– Keep a pulse of the major social issues (e.g. through local health departments, news / media outlets, etc.)
Identify appropriate community leaders, members and organizations
– Identify influential organizations and individuals who can be engaged to help the cause (e.g. local churches, large employers, political, faith and community leaders, local chapters of patient advocacy organizations, etc.)
Explore Connect Assess Maintain
[1] US Census data has county level race and ethnicity breakdown information (available at http://www.census.gov/cbdmap)
[2] As an example, NJ has Health Disparity Priority Areas site (available at https://www26.state.nj.us/doh-shad/indicator/CatDisparity.html) 6
Step 2 - ConnectInitiate Contact
Contact and engage community leaders, members and organizations
– Tailor the Template Letter (see details below) and send to the community organization(s) via email, mail, fax, or phone call
– Consider including with the letter:
• Your contact information and how/when to best reach you
• A brochure of your site or research department
• If appropriate, the IRB and Sponsor-approved study brochure
Explore Connect Assess Maintain
Template Letter
See TransCelerate Website for electronic
version.
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Step 3 - AssessNeeds Assessment
Identify and assess areas of common needs and collaboration opportunities
– Listen, learn and share:
• Learn how to effectively engage and share information with and build trust within the community
• Better understand how to support community social and health needs
• Understand their informational needs:
– Do they need general information on clinical trials or why diverse representation in clinical trials is important?
– Do they need information on a particular disease state?
– Do they understand the process of enrolling into a clinical trial (e.g. consent process, costs, how it is ethically monitored, privacy, tissue / blood collections, etc.)?
– Every community organization has different needs
• Be prepared to answer:
– What you can offer (e.g. education, funding, time, build a relationship, etc.)
– What you want from them (time at their next meeting to present information, sharing knowledge with you, be a conduit for information, etc.)
Explore Connect Assess Maintain
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Step 4 - MaintainMaintain Relationships
Building a rapport and maintaining relationships with community leaders, members and organizations can increase trust between practice and the community, but will take time. Be prepared to follow-up and stay engaged with them.
Build a rapport
– Offer tours of your facility—include Frequently Asked Questions that some may find intimidating about visiting health care institutions (i.e. where to park, onside café, bus schedules, financial support).
– Introduce the research team
– Use volunteers to review consent forms and studies for understandability (if your IRB and sponsor allows)
– Participate in Health fairs—getting into the community and making your research facility known
Stay connected
– Bridge and connect organizations with each other
Share information
– Share general clinical trial information and how your institution ensures the safety and well-being of your patients
– Share disease state information and prevention options
– Share information on a specific clinical trial
– Explain costs associated with clinical trials (what is typically covered by the insurance company, sponsor and patient)
Provide feedback
– Ensure information on progress and study results are shared
Explore Connect Assess Maintain
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Additional Information
• For any questions relating to this content, please contact Karen Brooks ([email protected]) or Kelly Kirsch ([email protected])
• Further information can also be found on the TransCelerate website (www.transceleratebiopharmainc.com)
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Toolkit Contents
Additional Reading and Further Materials to Help Educate Others
Resource What’s available Cost
CISCRP.org
https://www.ciscrp.org/
Online information, medical hero program, and a store with
resources ranging from general clinical trial information targeted
by audience (e.g. African Americans, Hispanics, and pediatrics) to
a full educational kit for community engagement.
$0.75 to $500
ClinicalTrials.gov
https://www.clinicaltrials.gov/ct2/search/map/cl
ick?map=NA%3AUS&map.x=460&map.y=115
List of open clinical trials; searchable by disease and by
geography.
Free
FDA.gov
http://www.fda.gov/
Information available for patents and healthcare providers. Also as
a FDA Patient network and links to resources such as Office of
Minority Health and Office of Women’s Health.
Free
I’m In Campaign (founded by National Minority
Quality Forum (NMQF and PhRMA)
https://www.joinimin.org/SitePages/index.aspx
Patients (and healthy volunteers) can join to be part of the Clinical
Trial Engagement Network. Links potential patients with clinical
researchers.. Focused on diversity representation in clinical trials.
Free
MedlinePlus
http://www.nlm.nih.gov/medlineplus/
Disease and health condition information in easy to understand
language. Information also available in Spanish.
Free
National Institutes of Health (NIH) Clinical
Trials and You
http://nih.gov/health/clinicaltrials/index.htm
General Clinical Trial Information for patients, including
downloadable posters and brochures. Resources also available in
Spanish. Online education for health care providers as well.
Free
downloads, but
printing costs
not incl.
ResearchMatch
www.Researchmatch.org
Website to connect volunteers with potential research studies
(healthy and those with a health condition).
Free
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Advocacy Organizations* (1/6)Black / African American (1/2)
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Organization Website
Below list provided by Karen Brooks, Pfizer(last updated 30-JAN-2015)
American Academy of Physical Therapy www.aaptnet.org
Association of Black Cardiologists, Inc. www.abcardio.org
Association of Black Psychologists www.abpsi.org
Black Congress on Health, Law, and Economics (BCHLE) www.bchle.org
The International Society on Hypertension in Blacks (ISHIB) www.ishib.org
Minority Health Professions Foundation www.minorityhealth.org
National Black Women’s Health Project, Inc. www.blackwomenshealth.org
National Dental Association www.ndaonline.org
National Medical Association (NMA) www.nmanet.org
National Optometric Association www.natoptassoc.org
National Organization of Blacks in Dietetics and Nutrition (NOBIDAN) www.nobidan.org
National Pharmaceutical Association www.npha.net
Student National Medical Association (SNMA) www.snma.org
American Black Chiropractic Association www.abcachiro.com
Association of Black Women Physicians www.blackwomenphysicians.org
Society of Black Academic Surgeons www.sbas.net
National Black Nurses Association www.npmaonline.org
National Podiatric Association www.npmaonline.org
The Congress of National Black Churches www.cnbc.org
Joint Center for Political and Economic Studies www.jointcenter.org
National Association for the Advancement of Colored People (NAACP) www.naacp.org
*Inclusion on this list does not indicate willingness to work with sites or sponsors
Advocacy Organizations* (2/6)Black / African American (2/2)
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Organization Website
National Association for Equal Opportunity in Higher Education (NAFEO) www.nafeo.org
National Association of Black Social Workers, Inc. (NABSW) www.nabsw.org
National Caucus and Center on Black Aged, Inc. (NCBA) www.ncba-aged.org
National Council of Negro Women (NCNW) www.ncnw.org
National Urban League www.nul.org
Sisters Network, Inc. www.sistersnetworkinc.org
National Association of Black Journalists www.nabj.org
National Council of Negro Women www.ncnw.org
National Newspaper Publisher’s Association www.nnpa.org
100 Black Men of America www.100blackmen.org/home.aspx
Blacks in Government www.bignet.org
Sickle Cell Organization of the Inland Counties
Black Biomedical Research Movement www.bbrm.org
The Links Foundation www.linksinc.org
The Coshar Foundation www.cosharfoundation.org
*Inclusion on this list does not indicate willingness to work with sites or sponsors
Advocacy Organizations* (3/6)Asian (1/2)
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Organization Website
Below list taken from National Partnership for Action
(last updated 05-FEB-2015)
http://minorityhealth.hhs.gov/npa/templates/content.aspx?lvl=3&lv
lid=31&ID=274
ASPIRA Association, Inc. http://www.aspira.org
Congressional Hispanic Caucus Institute (CHCI) http://www.chci.org
Cuban American National Council, Inc. http://www.cnc.org
Farmworker Justice http://www.fwjustice.org
Hispanic Association of Colleges and Universities http://www.hacu.net
Hispanic Dental Association http://www.hdassoc.org
Hispanic-Serving Health Professions Schools, Inc. (HSHPS) http://www.hshps.org
Interamerican College of Physicians and Surgeons (ICPS) http://www.icps.org
Inter-University Program for Latino Research (IUPLR) http://www.nd.edu/~iuplr
League of United Latin American Citizens (LULAC) http://www.lulac.org
MANA, A National Latina Organization http://www.hermana.org
Migrant Legal Action Program http://www.mlap.org
National Alliance for Hispanic Health http://www.hispanichealth.org
National Association of Hispanic Nurses http://www.thehispanicnurses.org
National Association of Puerto Rican and Hispanic http://www.naprhsw.com
National Council of La Raza (NCLR) http://www.nclr.org
National Hispanic Council on Aging (NHCOA) http://www.nhcoa.org
National Hispanic Medical Association (NHMA) http://www.nhmamd.org
National Latina Health Organization http://clnet.ucla.edu/women/nlho
National Latino Children's Institute (NLCI) http://www.nlci.org
National Latino Council on Alcohol and Tobacco Prevention (LCAT) http://www.nlcatp.org
Pan American Health Organization (PAHO) http://www.paho.org
Society for Advancement of Chicanos and Native Americans in
Science (SACNAS) http://www.sacnas.org
U.S.- Mexico Border Health Commission http://www.borderhealth.org/index.php*Inclusion on this list does not indicate willingness to work with sites or sponsors
Advocacy Organizations* (4/6)Asian (2/2)
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Organization Website
Below list taken from Asian American Health
(last updated 05-FEB-2015)http://asianamericanhealth.nlm.nih.gov/national.html
Association of Asian Pacific Community Health
Organizationhttp://www.aapcho.org/
Asian and Pacific Islander American Health Forum http://www.apiahf.org/
National Asian American Pacific Islander Mental Health
Associationhttp://naapimha.org/
*Inclusion on this list does not indicate willingness to work with sites or sponsors
Advocacy Organizations* (5/6)American Indian Alaska Native
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Organization Website
Below list taken from National Tribal Organizations
(last updated 04-FEB-2015)http://www.usa.gov/government/State-Local/Tribal-
Sites/National-Tribal-Organizations.shtml
American Indian Heritage Foundation http://www.indians.org/
American Indian Research and Policy Institute http://www.airpi.org/
American Indian Ritual Object Repatriation Foundation http://www.repatriationfoundation.org/index.html
International Indian Treaty Council http://www.iitc.org/
National American Indian Housing Council http://www.naihc.net/
National Center for American Indian Enterprise
Developmenthttp://ncaied.org/
National Congress of American Indians http://www.ncai.org/
National Indian Gaming Association http://www.indiangaming.org/
National Indian Gaming Commission http://www.nigc.gov/
National Indian Health Board http://www.nihb.org/
National Tribal Justice Resource Centerhttp://web.archive.org/web/20010515202310/http://ww
w.tribalresourcecenter.org/
Native American Finance Officers Association http://www.nafoa.org/
Native American Sports Council http://www.nascsports.org/
*Inclusion on this list does not indicate willingness to work with sites or sponsors
Advocacy Organizations* (6/6)Hispanic / Latino
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Organization Website
Below list taken from National Partnership for Action
(last updated 05-FEB-2015)
http://minorityhealth.hhs.gov/npa/templates/content.aspx?lvl=3&lvlid=31
&ID=274
ASPIRA Association, Inc. http://www.aspira.org
Congressional Hispanic Caucus Institute (CHCI) http://www.chci.org
Cuban American National Council, Inc. http://www.cnc.org
Farmworker Justice http://www.fwjustice.org
Hispanic Association of Colleges and Universities (HACU) http://www.hacu.net
Hispanic Dental Association http://www.hdassoc.org
Hispanic-Serving Health Professions Schools, Inc. (HSHPS) http://www.hshps.org
Interamerican College of Physicians and Surgeons (ICPS) http://www.icps.org
Inter-University Program for Latino Research (IUPLR) http://www.nd.edu/~iuplr
League of United Latin American Citizens (LULAC) http://www.lulac.org
MANA, A National Latina Organization http://www.hermana.org
Migrant Legal Action Program http://www.mlap.org
National Alliance for Hispanic Health http://www.hispanichealth.org
National Association of Hispanic Nurses http://www.thehispanicnurses.org
National Association of Puerto Rican and Hispanic Socia http://www.naprhsw.com
National Council of La Raza (NCLR)
Raul Yzaguirre Building http://www.nclr.org
National Hispanic Council on Aging (NHCOA) http://www.nhcoa.org
National Hispanic Medical Association (NHMA) http://www.nhmamd.org
National Latina Health Organization http://clnet.ucla.edu/women/nlho
National Latino Children's Institute (NLCI) http://www.nlci.org
National Latino Council on Alcohol and Tobacco Prevention (LCAT) http://www.nlcatp.org
Pan American Health Organization (PAHO) http://www.paho.org
Society for Advancement of Chicanos and Native Americans in Science
(SACNAS) http://www.sacnas.org
U.S.- Mexico Border Health Commission http://www.borderhealth.org/index.php
*Inclusion on this list does
not indicate willingness to
work with sites or
sponsors
