1. Minorities and the medically underserved in clinical trials Edward L. Trimble, MD, MPH CTEP, DCTD, NCI

2. Why clinical trials need to be representative We need definitive tests of interventions in the same people who have cancer or who are at risk of cancer. Can we deliver the intervention in the community setting? Do genetics, culture, SES, or co-morbidity affect toxicity or efficacy of treatment?

3. Who has been under-represented on treatment trials?: I Older patients, especially those 70+ with co-morbidity Adolescent and young adults (ages 15-39) African-American, Asian-American, Hispanic-American, and Native American men and women

4. Who has been under-represented on treatment trials?: II Residence in rural counties Residence in counties with lower educational levels and higher unemployment rates Difficulties with access to regular health care and centers with clinical trials

5. Ongoing NCI initiatives focused in expanding accrual to trials CCOP and MBCCOP programs Cancer Disparities Research Partnership Program National Community Cancer Center Program

6. Overcoming Barriers Initiative Early phase (I, II) trials at 7 NCI- designated Cancer Centers Public-private partnership with Friends of Cancer Research and pharma UC Davis: public, community, and professional education U of Colorado/ Moffitt: patient navigators for older patients

7. Overcoming Barriers: II Washington University: patient navigators (‘coaches’) OSU: community education, patient education, pre-screening via informatics, PC tablets for trial availability, informed consent ‘short forms’ in multiple languages

8. Overcoming Barriers: III Mass General: patient navigator/ research nurse in community hospital serving poor immigrants; education for translators U of Pittsburgh: satellite clinics linked by telemedicine & informatics San Antonio: survey of physicians serving Hispanic-American cancer patients

9. NCI Office of Communications Encompasses Office of Education and Special Initiatives Education for health care professionals about clinical trials Public and community education about clinical trials

10. Partnerships American Cancer Society Centers for Disease Control and Prevention Intercultural Cancer Council –Eliminating Disparities in Clinical Trials (EDICT): CLAS-ACT, BackPack Lance Armstrong Foundation –Education Network to Advance Cancer Clinical Trials (ENACCT)

11. NCI I2 Team on Cancer Health Disparities I2: Integration and Implementation Chair: Sanya Springfield, PhD Currently drafting proposals to go to Dr. Niederhuber and NCI Executive Committee

12. I2 CHD draft proposals: I Include health disparities outcome as a primary or secondary objective in clinical trials Where appropriate, integrate community- based participatory research approaches in clinical trials

13. I2 CHD draft proposals: II Require patients to self-report race and ethnicity consistent with OMB and US Census guidelines Capture proxy measures of socio-economic status (SES) on all patients (educational level, census tract of residence)

14. I2 CHD draft proposals: III Oversample minority or underserved populations in phase III clinical trials for cancers which are more prevalent, whose outcomes are more severe, or for which biological indicators of differences underlie disparities Increase per-capita reimbursement for complexity of case and trial

15. I2 CHD draft proposals: IV Collect information on barriers to and promoters of accrual to trials Compile and disseminate best practices for clinical trials accrual and retention Evaluate promising new strategies for accrual, using standardized criteria

16. I2CHD draft proposals: V Include accrual to health disparities research as a program/ project goal Include effective accrual strategies among review criteria for new phase III trials and large cohort studies Include appropriate funding for accrual and retention in awards (including bonus payments)

17. I2 CHD draft proposals: VI Evaluate institutional costs for recruitment and retention Evaluate existing models: CCOPs, MBCCOPS, core facilities, patient navigators Expand the use of effective models

18. I2 CHD draft proposals: VII Where appropriate and safe, expand eligibility criteria Design trials for patients with co- morbidities Strengthen cultural competence in design and conduct of clinical research

19. Comments/ suggestions Ken Chu (kc10d@nih.gov) Worta McCaskill-Stevens (mccaskiw@mail.nih.gov) Ted Trimble (tt6m@nih.gov)