Recruitment and Accrual of Special Populations

Recruitment and Accrual of
Special Populations
Special Population Committee
Elizabeth A. Patterson M.D.,
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Accrual of Special Populations
 Why should we be
 NIH Revitalization Act
in 1993 requirement
 Participation in clinical
trials is important for
elimination of health
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ACRIN Special Populations Tutorial
 This training tutorial provides ACRIN
researchers, research associates (RAs)
and advocates with information regarding
the importance of diversity in ACRIN
clinical trials.
 The tutorial has been developed in
collaboration with the ACRIN Special
Populations Committee and ACRIN
headquarters staff.
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The National Institutes of Health (NIH)
Revitalization Act in 1993 was designed to
address disparities in the participation in
clinical trials. Signed into law on June 10,
1993 and amended October, 2001, the
Revitalization Act directed the NIH to
establish guidelines for inclusion of women
and minorities in clinical research.
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NIH Policy and Guidelines
 "NIH Outreach Notebook on the Inclusion of
Women and Minorities in Biomedical and
Behavioral Research."
 The notebook as well as the Frequently Asked
 NIH Policy and Guidelines on The Inclusion of
Women and Minorities
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The ACRIN Special Populations
Comprises two modules
1. Demographics and Prevalence of Cancer
Related Disease
2. Strategies for recruitment of women,
minorities and medically underserved
populations into clinical trials.
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Disparities affect many populations:
racial and ethnic minorities
residents of rural areas
children and adolescents
the elderly
people with disabilities
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Cancer related disparities
 Incidence and mortality rates from lung cancer are
higher among African American men than in
whites, even though they begin smoking at an
older age and smoke fewer cigarettes per day.
 The Appalachian region has a higher mortality rate
for all cancers in the United States as a whole.
 Vietnamese women have a higher cervical cancer
incidence rate than any ethnic group in the United
States, approximately fives times the incidence in
non-Hispanic white women.
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All Sites
Racial/Ethnic Group
African American/Black
Asian/Pacific Islander
American Indian/Alaska Native
Table. Overall Cancer Incidence and Death Rates
Statistics are for 2000-2004, age-adjusted to the 2000 U.S. standard million population, and represent the number of new cases of
invasive cancer and deaths per year per 100,000 men and women.
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Module 2
Strategies for recruitment of women,
minorities and medically underserved
populations into clinical trials.
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Barriers to Recruitment
Barriers that limit participation are
multifactorial and complex
Vary from one population to another
 Lack of awareness of clinical trials
 Lack of opportunity and access
 Individual beliefs regarding participation in
medical research
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Barriers of awareness
May be affected by
 the health literacy of potential participants
 failure of dissemination regarding clinical trials
to possible participants and/or their health
care providers.
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Lack of opportunity and access
May be related to
 health insurance status
 potential cost or time required by
 geographic accessibility
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United States Population Distribution
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ACRIN Institutions
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Individual beliefs regarding
participation in medical research
 Vary by to race/ethnicity, social economic
status, educational status, and geographic
 Factors that are of great concern to one
subgroup may be inconsequential to
another subgroup
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Individual Concerns
 Concerns about trial procedures such as
safety and adverse effects of therapy
 mistrust of the medical and/or research
 cultural differences between possible
participants and researchers
 specific concerns regarding historical
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Strategies for the Recruitment of
Special Populations
 Differences in cultural perceptions regarding
healthcare utilization and research should be
considered when developing strategies for
the recruitment of participants from culturally
diverse populations.
 The strategies used for recruitment should
reflect the recruitment target population.
 For all populations, health care providers
have a crucial role in increasing referrals for
clinical trials.
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Recommendations for
Successful Recruitment:
 Acknowledgement that the recruitment of a diverse
study population is not an investigator choice; it is a
mandate from the NIH.
 Establishment of minority/special populations accrual
goals based on prevalence or incidence of disease
 Development of recruitment strategies for special
populations in advance of trial launch, optimally at the
time of protocol development
 Selection of sites based on prior site success in
minority recruitment and a plan in place to recruit
special populations
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Strategies for special populations
recruitment include but are not limited
 For the protocol development team
 For the site
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The Protocol Development Team:
 Flexibility in trial design and site
operations should be considered during
concept design and protocol development.
 Involvement of investigators of diverse
backgrounds in protocol development and
at the time of site selection.
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For the Sites:
Mass and targeted mailings
Local or national radio ads
Local or national television ads
Collaboration with community based
organizations (CBO) and faith based
organizations (FBO)
 Collaboration with "wellness" programs at sites of
employment of possible clinical trial participants
 Collaboration with social service agencies to
provide information regarding health services
and clinical trial activities
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For the sites: (Cont.)
 Cultural adaptations of recruitment materials
 Community based advisory committees and promotion
of trial by community leaders or trial champion/thought
 Collaboration with local health care providers/clinicians
 In populations with limited literacy, informed consents
read aloud in English, Spanish or the language of the
targeted population with scripts adjusted to less than
6th grade level readability.
 Development of memorandum of understanding with
other research groups within the same institution to
share expertise in recruitment of special populations
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 Effective recruitment and retention of racial
and ethnic minorities, women and medically
underserved populations is critical in
improving health disparities and in the
treatment and prevention of cancer in all
 Future goals should include better
understanding of barriers and strategies to
recruitment of special populations as well as
strategies to increase the diversity of
scientists and researchers.
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We invite you to let us know
what you think about the tutorial.
Please send your comments to:
[email protected]
Thank You
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