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Recruitment and Accrual of Special Populations

Special Population CommitteeElizabeth A. Patterson M.D.,

Chair

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Accrual of Special Populations

· Why should we be concerned?

· NIH Revitalization Act in 1993 requirement

· Participation in clinical trials is important for elimination of health disparities.

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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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Background

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 Questions http://grants.nih.gov/grants/funding/women_min/women_min.htm

· NIH Policy and Guidelines on The Inclusion of Women and Minorities http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm

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The ACRIN Special Populations Training

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

Disparities affect many populations: racial and ethnic minorities residents of rural areas women 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 Incidence Death

All 470.1 192.7

African American/Black 504.1 238.8

Asian/Pacific Islander 314.9 115.5

Hispanic/Latino 356.0 129.1

American Indian/Alaska Native 297.6 160.4

White 477.5 190.7

Table. Overall Cancer Incidence and Death RatesStatistics 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

participants· 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 location

· 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 community

· cultural differences between possible participants and researchers

· specific concerns regarding historical events

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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

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 leaders

· 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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Conclusion

· 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 populations.

· 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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Thank You

We invite you to let us know what you think about the tutorial. Please send your comments to: specialpopulations@acr.org.