# Presentation: 142717

## Minorities and the medically underserved in clinical trials

- Edward L. Trimble, MD, MPH
- CTEP, DCTD, NCI

## 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?

## 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

## 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

## Ongoing NCI initiatives focused in expanding accrual to trials

- CCOP and MBCCOP programs
- Cancer Disparities Research Partnership Program
- National Community Cancer Center Program

## 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

## 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

## 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

## 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

## 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)

## 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

## 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

## 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)

## 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

## 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

## 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)

## 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

## 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

## Comments/ suggestions

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