Building a Framework for Equity Enrollment in Oncology Trials

WHO ARE WE ?

SOURCES: 1.Intercultural Cancer Council. Cancer Facts: African Americans & Cancer. Available at: http://www.iccnetwork.org/cancerfacts/AfrAmFactSheetRevJune2011Post.pdf. Accessed January 16, 2014. 2.Intercultural Cancer Council. Cancer Facts: American Indians/Alaska Natives & Cancer. Avail-able at: http://www.iccnetwork.org/cancerfacts/AmIndAlNativeFactSheetRev2012Post.pdf. Accessed January 16, 2014. 3.Intercultural Cancer Council. Cancer Facts: Children/Adolescents & Cancer. Avail-able at: http://www.iccnetwork.org/cancerfacts/ChildrenFactSheetJan2011RevPost.pdf. Accessed Jan-uary 16, 2014. 4.Intercultural Cancer Council. Cancer Facts: Elderly & Cancer. Available at: http://www.iccnetwork.org/cancerfacts/ElderlyFactSheetJan2011RevPost.pdf. Accessed January 16, 2014. 5.Inter-cultural Cancer Council. Cancer Facts: Hispanics/Latinos & Cancer. Available at: http://www.iccnetwork.org/cancerfacts/HispFactSheetJune2011RevPost.pdf. Accessed January 16, 2014. 6.Intercultural Can-cer Council. Cancer Facts: Native Hawaiians/Pacific Islanders & Cancer. Available at: http://www.iccnet-work.org/cancerfacts/HawaiianPacIslFactSheetJan2011RevPost.pdf. Accessed January 16, 2014. 7. Intercultural Cancer Council. Cancer Facts: Rural Poor/Medically Underserved Americans & Cancer. Available at: http://www.iccnetwork.org/cancerfacts/RuralFactSheetJune2011RevPost.pdf. Accessed January 16, 2014. 8. The Office of Minority Health. Cancer Data/Statistics. Available at: http://www.mi-norityhealth.hhs.gov/templates/browse.aspx?lvl=3&lvlid=4. Accessed January 16, 2014. 9.The Office of Minority Health. Cancer and American Indians/Alaska Natives. Available at: http://www.minorityhealth.hhs.gov/templates/content.aspx?lvl=3&lvlID=4&ID=3023. Accessed January 16, 2014. 10.The Office of Minority Health. Cancer and Asians/Pacific Islanders. Available at: http://www.minorityhealth.hhs.gov/templates/content.aspx?lvl=3&lvlID=4&ID=3055. Accessed January 16, 2014. 11.The Office of Minori-ty Health. Cancer and Hispanic Americans. Available at: http://www.minorityhealth.hhs.gov/templates/content.aspx?lvl=3&lvlID=4&ID=3323. Accessed January 16, 2014. 12. Coalition of Cancer Coopera-tive Groups for the Global Access Project. Baseline Study of Patient Accrual onto Publicly Sponsored Trials. National Patient Advocate Foundation. April 2006. 13. Lara PN Jr, Paterniti DA, Chiechi C, Turrell C, Morain C, Horan N, et al. Evaluation of factors affecting awareness of and willingness to participate in cancer clinical trials. J Clin Oncol. 2005;23(36):9282-9289. 14. ENACCT. ENACCTION Newsletter March 2013. Available at: http://www.enacct.org/whats-new/newsletters/enacction-newsletter-march-2013. Ac-cessed March 26, 2013. 15. Grann VR, Jacobson JS, Troxel AB, Hershman D, Karp J, Myers C, et al. Barriers to minority participation in breast cancer prevention trials. Cancer 2005;104(2):374-379 16. Gross CP, Filardo G, Mayne ST, Krumholz HM. The impact of socioeconomic status and race on trial participation for older women with breast cancer. Cancer. 2005;103(3):483-491.17. CenterWatch News Online. PhRMA joins National Minority Quality Forum’s collaboration to increase diversity in clinical trials. Available at: http://www.centerwatch.com//news-online/article/4987/phrma-joins-national-minority-quali-ty-forums-collaboration-to-increase-diversity-in-clinical-trials. Accessed August 29, 2013.18. Research America! Clinical Trials: Poll Data of Minority Populations. Available at: http://www.researchamerica.org/uploads/clinicaltrialsminorities.pdf. Accessed August 29, 2013. 19. Symonds RP, Lord K, Mitchell AJ, Raghavan D. Recruitment of ethnic minorities into cancer clinical trials: experience from the front lines. Br J Cancer. 2012;107(7):1017-1021. 20.Getz K. Clinical Trial Complexity. Available at: http://www.iom.edu/~/media/Files/Activity%20Files/Quality/VSRT/LST%20Workshop/Presentations/Getz.pdf. Accessed March 15, 2013. 21.Getz K. Clinical Trial Complexity. Available at: http://www.iom.edu/~/media/Files/Ac-tivity%2Files/Quality/VSRT/LST%20Workshop/Presentations/Getz.pdf. Accessed March 15, 2013.

AWARENESS OF CLINICAL TRIAL

1STA

GE

BARRIER STRATEGYPatient lack of awareness

Culturally-appropriate knowledge about the origins of cancer

Physician lack of awareness

Public education

Communication between healthcare team members and within study centers

WHO ARE UNDERREPRESENTED? 1-11 »

AFRICAN AMERICANS 40 million Americans 13% of the total US population

For all cancer sites combined, cancer death rates are HIGHER than any other racial or ethnic population in the US.

Death rate from all cancers: 33% higher in men & 16% higher in women.

Only 31% of African American patients were willing to participate in a clinical trial.

ELDERLY37.3 million Americans 12% of the total US population In 2003, 61% of new cancer cases occurred among the elderly, only 25% of cancer trials participants are over 65 years of age.

In Phase II & III clinical trials, they carried 60% of the disease burden. Representing 32% of enrolled patients.

90% of colorectal cancer cases in the US occur after age 50.

HISPANICS/LATINOS 48.5 million Americans 16% of the total US population Compared to non-Hispanic/Latino white physicians, Latino physicians were significantly less involved with clinical trials and found less value in them.

Among women, cervical cancer incidence is 2 to 3X times higher than in non-Hispanic/Latino white women.

Both men & women are TWICE as likely to have, &to die from, liver cancer.

ASIAN AMERICANS 14.1 million Americans

5% of the total US populationwith the largest numbers

in CA,NY, HI, TX and NJ.

Colorectal cancer is the 2nd most common diagnosed cancer, & 3rd highest cause of

cancer-related mortality.

Men have 2.4 times & womenhave 2.7 times, the incidence

of liver & IBD cancer.

Men are 2X as likely to die from stomach cancer, women are

2.7 times as likely to die from the same disease.

NATIVE HAWAIIANS/ PACIFIC ISLANDERS

0.1% of the total US population, more than 25 diverse peoples with distinct variations in backgrounds,

languages & traditions.

Cancer is the leading cause of DEATH. Breast carcinoma is the #1

cause of cancer-related mortality.

30% more likely to be diagnosed with cancer. LOWEST cancer screening & early detection

rates of all ethnic groups.

AMERICAN INDIANS/ ALASKA NATIVES

4.5 million Americans 1.5% of the total U.S. population

scattered over 560 federal and over 100 State recognized tribes.

Cancer is the 3rd leading causeof DEATH of all ages & the 2nd leading cause of DEATH among

peoples over the age of 45.

Cancer cases increased dramaticallyfrom 1994 to 2003. These cancers

constitute 45% of approx. 6,000 diagnosed cases in the past 35 years.

Women are 1.7 times as likely to die from cervical cancer

as compared to non-Hispanic/Latino white women.

CHILDREN/ADOLESCENTS 72.3 million Americans 26% of the total US population 50% of children with cancer are enrolled into treatment trials. Research suggests they tend to present with more advanced & aggressive diagnoses. 2% of all invasive cancer diagnoses. Girls from birth to 14 years old, the rate of ovarian cancer is: highest among Asian Pacific Islanders (5.7 per million), byAfrican Americans (4.2 per million) & non-Hispanic/Latino whites(3.8 per million).

DISPARITIES & OUTCOMES

RACE ETHNICITY

ENROLLMENT BY RACE & ETHNICITY 12 »EQUITABLE ENROLLMENT: BREAKING DOWN BARRIERS »

RURAL POOR 7.3 million Americans

15.1% of the total US population

From 2001-2003, Appalachian men & women

had the highest incidencerates in all sites combined

(415 per;100,000) when compared to the

U.S. general population (398 per;100,000).

Public education2STAGE

OPPORTUNITIES TO JOIN TRIALS

BARRIER STRATEGYStudy design barrier

Lack of physician referral

Race/ethnicity

Socioeconomic condition

Inadequate health insurance

Informed protocol development

Internet-based resources

Increased insurance coverage

Advocacy groups

3STAGE

DECIDE TO ENROLL

BARRIER STRATEGYMistrust of research & the medical system

Perceived harms

Protocol complexity can create time, income, and transportation challenges for patients

Molecular profilingSimplified trial design

Alternative trial sites