Cancer Clinical Trials

1. Clinical Cancer Research in a Fail-safe Hospital:Mitigating Myths Of MistrustSteven Wolff, M.D., Meharry Medical College

2. Cancer Clinical Trials • 20% of adults are eligible for a cancer clinical trial. • Less than 3% of adults participate. • Even less for minority and medically underserved. • Minorities are as willing to participate as whites. • But are less likely to be invited to participate. • Subjects insured with higher SES .

3. Underrepresented Groups • Rural patients • Patients of lower SES • Adolescents and young adults • Older patients (65+ years), especially with co-morbidities • AA men, Hispanic, Asian, Native American women and men

4. Barriers to Accrual • National health policy • Local research infrastructure • Providers of health care • Research studies • Patient based issues

5. Social Barriers to Clinical Trials “Even when they have health insurance, people with low income often have more difficulty gaining access to the care they need. They may be faced with such challenging circumstances as disconnected telephones, transportation difficulties, multiple or inflexible jobs, unaffordable copayments for medication, and often cultural and language barriers as well. For low-income patients who manage to obtain care, adherence to treatment plans may also be complicated by competing priorities. Many low-income families must make tradeoffs between health care and other basic needs, such as housing, food, and heat.”

6. Limited Accrual to Clinical Trials • Complex issue similar to health disparities • Compounded for the underserved/minority • Caused by STRATEGIC&LOGISTIC issues • Improved by targeted solutions • Solved by affecting multiple issues

7. Barriers to Accrual JG Ford et al. Cancer January 15, 2008 / Volume 112 / Number 2

8. Barriers to Opportunity • LOCAL INFRASTRUCTURE • Leadership commitment for clinical trial accrual • Academic credit • Salary and RVU credit • Administrative and financial management • Data management and auditing • Research nursing and study management • Patient management • Investigational pharmacy • CRC and clinical care capabilities • Integration between basic and clinical research

9. Barriers to Opportunity • PROVIDER BASED • Clinical trial focus • Clinical trial commitment in a practice • Time commitment availability • Conflict between practice and research • Financial impact practice and individual • Clinical trial training and management

10. Barriers to Opportunity • STUDY BASED • Disease appropriate studies • Stage appropriate studies • Co-morbidity eligibility • Schedule testing appropriateness • “Generalizability” of results

11. Barriers to Acceptance • PATIENT BASED • Transportation and follow-up access • Communication and health literacy • Cultural based insight • Knowledge about clinical trials • Trust or fear of the health care system • Study process capability • Home care and other mandated processes • Peer group support and mentoring

12. Nashville General Hospital Meharry Medical College Fail-safe public hospital with large proportion of uninsured and underinsured patients serving as the main clinical campus

13. Patients at the NGH

14. Patients at the NGH

15. Patients at the NGH

16. Patients at the NGH

17. Patients at the NGH

18. Research Emphasis • We committed, as an academic teaching institution, to maintain an environment of clinical research in the context of clinical care. • To do so, we modeled the environment with a primary emphasis on clinical and translational research

19. Research Emphasis • We leveraged multiple sources of funding for program support. • MBCCOP, ARRA, MMC/VU U54. • Hospital supported the program by upgrading clinic and infusion facilities.

20. Initial Pessimism • General concept that underserved or minority patients would not participate in clinical research. • “If you make it, they still won’t come”

21. Clinical Trial Accrual Process

22. Clinical Trial Accrual Process Patient centric environment of trust Program emphasis on clinical trials Prospectively identify subjects for clinical trials Screen each cancer patient Proactive and not reactive Evaluate patients for study requirements Plan testing as part of the primary effort Discuss clinical trials early in the course of care Support of clinical staff for clinical trials

23. Safety Net HospitalBarriers Noted 2001-2004 • Co-morbidity 27% • Eligibility 23% • Performance status 17% • Refused treatment 11% • Dept of corrections 7% • Refused research 4% • Refused specific trial 4% • Returned to local MD 3% • Insurance 1% • Lost to follow up 1% • Transportation 1% Wolff, SN, Wujcik, D, unpublished data

24. Clinical Trial Accrual Process

25. Clinical Trial Accrual Process

26. Clinical Trial Accrual Process

27. Clinical Trial Accrual Process

28. Clinical Trial Accrual Process

29. Confounders and Bias Fail-safe hospital with most patients having no other health care alternative Relatively small number of patients Academic center with dedication for teaching and clinical research Adequate staff resources Care in an HBCU with well-established position in the community

30. It Takes a Program to Make a Program