Minorities and the medically underserved in clinical trials

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_at_nih.gov)
• Worta McCaskill-Stevens (mccaskiw_at_mail.nih.gov)
• Ted Trimble (tt6m_at_nih.gov)