Reducing Disparities in Clinical Trials

1. Reducing Disparities in Clinical Trials

2. WHY WE NEED TO TELL THIS STORY Three friends-Jim, Bill and Peter-- were walking down the street. Jim said, "I gave blood today." Peter said, "That's terrific! You are a scholar and a gentleman." Bill said, "After a lot of thought, I've decided to donate a kidney." Jim said, "That's beyond terrific! You are a prince among men." Peter said, "Well, I'm not giving blood, and I'm not donating a kidney, but I plan to enroll in a clinical trial tomorrow." Jim and Bill said, "What? Are you crazy?" PUBLIC PERCEPTION IS POOR

3. RECRUITMENT COSTS ARE INCREASING

4. The Overall Problem: Enrollment Delays Foy, 2003

5. Characteristics of successful studies • Continuing medical education for physician and staff • Printed educational materials for subjects • Incentives to patients • Use of local opinion leaders

6. Low Minority Participation • Minorities are less likely to enroll in studies compared to white males • Despite high disease burden, less than 5% of participants in Breast and Prostate Cancer prevention trials were minority • 1996 to 2002 annual # of trial participants increased from 8,000-12,000 but minority participation decreased. Hispanic & Blacks represented 3.7% and 11.0% in 1996 but down to 3.0% and 7.9% in 2002 Murthy, 2004

7. Low Minority Participation • Local Data: Fox Chase Cancer Center (Northeast Philadelphia)-data from 2004 Catchment area: 18% Black, 6% Hispanic, 3% Asian, 71% White Minority patient accrual: 8% Black, 2% Hispanic, 1% Asian, 89% White Minority patient recruitment: 6% Black, <1% Asian and Hispanic each Bruner, 2006

8. Minority Participation: UH Experience • UMDNJ – University Hospital (UH) data In 2007 there were 1132 newly identified cancer patients: 32% white NH, 35% black NH, 23% Hispanic. There were 43 active cancer trials that enrolled a total of 54 patients, representing an overall enrollment rate of 4.8%. 5.1% of blacks enrolled (20/396) 4.6% of Latinos enrolled (12/260) Thus, participation rates among racial and ethnic groups were similar at UH.

9. Sponsored-centered Barriers to Recruitment • Protocol issues • Adequate Funding • Site Selection • Investigator Selection

10. Clinician centered barriers • Time Constraints • Lack of support staff • Impact on doctor-patient relationship • Concern for patients • Clinician bias

11. Clinician centered barriers • Loss of professional autonomy • Obtaining consent • Poor financial reimbursement • Lack of interest in the specific research question

12. Barriers to Patient Participation • Demands of the study • Preference for a particular treatment • Concerns about side effects • Comfort level with physician • Language and literacy • Loss of privacy • Portrayal as guinea pig

13. Distrust as a Barrier to Participation • Mistrust of scientific investigators and of academic institutions were major barriers among Blacks Providing informed consent was reported as relinquishing rather than protecting rights Research volunteer is considered a“guinea pig” Knowledge of the Tuskegee Syphilis Study was not necessarily negatively associated with willingness to participate Yancey, 2006

14. Who bears the greatest Risk Shavers, 2002

15. Barriers to Recruiting Minorities for Cancer Trials • Systematic review to determine barriers to participation of underrepresented populations in cancer trials: 1966-2005 Barriers to: -trial awareness -opportunity to participate (research design, provider attitudes) -acceptance of enrollment (perceived harms, mistrust) --additional barriers related to cultural factors Ford, 2007

16. Barriers to Recruiting Minorities for Cancer Trials Examination of Community Members’, Researchers’ and Health Professional perceptions of barriers to minority recruitment (Robinson JM, 2007) • Cluster: Recruitment Issues Minorities unaware of medical research Lack of cultural sensitivity in communications Lack of resources to treat the uninsured if found to be sick • Cluster: Patient concerns Lack of awareness of benefits to participation Sense that subjects only give and get nothing Concerns about signing ICF • Cluster: Fears Fear of being a guinea pig Fear of unknown

17. Barriers to Recruiting Minorities for Cancer Trials Cluster: Psychosocial/socioeconomic issues More pressing survival problems Cultural beliefs/Religious beliefs Mental illness, homelessness Cluster: History/past experiences Previous negative experience Literacy issues Mistrust due to discriminatory social/historical/legal experiences Cluster: Resources/Financial considerations Lack of health coverage to reimburse medical interventions in protocol Presentation at late stage for many minority patients Dismal past record of translating research into practice in underserved community

18. Barriers to Recruiting Minorities for Cancer Trials • Cluster: Research System Issues Lack of adequate MD education in providing patient’s information about trials Lack of incentive for overworked MDs caring for minorities Inappropriate outreach methods • Cluster: Researcher Bias MD fear of losing patients Poor Relationship between medical institution and community Lack of follow-up • Cluster: Issues in Research Method, Design, Management Not linking research to what minority communities need Lack of minorities as PI Lack of bilingual researchers

19. Barriers to Recruiting Minorities for Cancer Clinical Trials R=.29

20. Barriers to Recruiting Minorities for Cancer Clinical Trials R=.11

21. Barriers to Recruiting Minorities for Cancer Clinical Trials R=-.16

22. Recruitment Strategies

23. Recruitment Efforts • NIH Revitalization Act mandated minority inclusion in randomized clinical trials, 1993 • Review criteria in NIH study sections have formally required minority recruitment or scientific justification for their exclusion • Rep. Edolphus Towns (Democrat, NY) was expected to submit legislation that would offer delayed generic competition to companies that conduct minority focused clinical trials.

24. Recruitment Categories • Passive-disseminating information in the target population via flyers, advertisements, mailings, public service announcements • Active-bringing the project staff directly into contact with prospective participants via telephone or in-person appeals by project staff and medical providers

25. Recruitment Strategy: Community involvement • Use lay outreach workers from the targeted population (cultural insider) • Community-based organizations particularly for Blacks • Places of Worship: Although some investigators have identified religiosity as a barrier due to a fatalistic view of disease –others have found religiosity to be positively associated with willingness to participate

26. Very few patients are aware that they are eligible to participate In a clinical trial

27. What is it? One day educational program free and open to the public Local physician speakers provide information to help people make informed decisions about clinical research participation General session lecture – “What Clinical Research Means to You!” Educational workshops – focused on disease states and issues such as women or minorities in clinical research Patient Panel – real life stories of clinical research participation

28. Purpose and Value Takes awareness-building into the heart of the community via traditional outreach and advocacy strategies Builds a grass-roots movement by engaging and informing political figures, opinion leaders, physicians, healthcare providers and other stakeholders Changes perception of the clinical research participant from that of “guinea pig” to that of Hero

29. Attendee Evaluations Self-reported knowledge of the clinical research process: Attendees who were not previously in a clinical trial n = 66 n = 65 Before AWARE for All After AWARE for All

30. Attendee Evaluations Likelihood of participating in a clinical trial: n = 108

31. Recruitment Strategy: Minority Principle Investigators • Minority investigators are under-represented among the pool of all active clinical investigators (Getz, 2008)

32. Recruitment Strategy: Friendly Informed Consent • Health literacy: degree to which people can obtain, process and understand basic health information and services they need to make appropriate health decisions. It is not just about reading and writing, but includes all the ways people communicate health information such as by speaking, drawing pictures and using technology. • Most consents are on a 12th grade reading level • Provide consent in different languages, use “comfort” words, pictures, diagrams • Voice-enhanced ICF • Yates, 2009 developed a 23 page ppt flip chart for an IC-study comparing traditional cardiac rehab vs home-based cardiac rehab-improved participation rate from 22%-54%

33. Recruitment Strategy: Clinical Trial Alert Systems • Configured the EHR to trigger an alert if a patient is likely eligible for an ongoing clinical trial CTA is set to trigger only during clinical encounters If MD elects to proceed , a customized CTA order form appears—reminds MD to assess a few additional eligibility criteria MD clicks appropriate box 1) yes patient meets criteria and is interested;2. No, patient does not meet criteria; 3. No patient meets criteria but not interested. Message sent to trial coordinator’s workstation • CTA addresses obstacles to MD participation in recruitment

34. Recruitment Strategy: General • Adequately characterize the target population • Involve members of the target population in planning efforts • Take message to the target population • Give something back to the community • Enhance credibility of study by using a community spokesperson • Identify and remove barriers to participation • Cultural relevance of materials • Improve staff sensitivity • Stress importance of prevention and early detection • Use of women to encourage participation by males

35. Recruitment Strategy: Print Media • Mass mailing of brochures/flyers with personalized letters -across ethnic groups • Secondary source was referral by a friend for Hispanics and Blacks and newspaper ads/articles and brochures for whites • Overall recruitment through the health system produced a higher randomization yield than did newspaper and radio public service announcements or faith-based organizations • Recruits from faith-based organizations were more likely to stay in the study

36. New Media • Study specific websites • Email • Banner Advertising • Chat rooms & forums • Podcasts • Search engine advertising

37. Target Audience • Men—newspapers • Elderly—TV and newspapers • Adult children and spouses of the patient-direct mail, newspapers, radio and online advertising • Young mothers--magazines and online advertising

38. Components of a Good Ad • Creative • Get noticed • Offers news • Compelling message • Succinct message • Meaningful to patient • Use Emotion • Pleasing colors • Catchy study name

39. Conclusions • There is equal willingness among minorities and whites to participate in clinical trials • Lack of awareness and lack of understanding of the benefits of participation are probably the biggest obstacles • Mistrust remains an issue • Community involvement is imperative for enrollment to grow

40. No more hand-me-downs: Research Designed for Children

41. References • Bruner, D.W., et al., Reducing cancer disparities for minorities: a multidisciplinary research agenda to improve patient access to health systems, clinical trials, and effective cancer therapy. Journal of Clinical Oncology, 2008. 24(14): p. 2209-2215. • Ford J.G, et al., Barriers to recruiting underrepresented populations to cancer clinical trials: A systematic review. Cancer, 2008. 112(2): p. 228-242. • Foy, R., et al., How evidence based are recruitment strategies to randomized controlled trials in primary care? Experience from seven studies. Family Practice, 2003. 20(1). • Getz, K. and L. Faden, Racial disparities among clinical research investigators. American Journal of Therapeutics, 2008. 15: p. 3-11. • Joseph, G., C.P. Kaplan, and R.J. Pasick, Recruiting low-income healthy women to research: an exploratory study. Ethnicity and Health, 2007. 12(5): p. 497-519.

42. Murthy, V.H., H.M. Krumholz, and C.P. Gross, Participation in cancer clinical trials. JAMA, 2004. 291(22): p. 2720-2727. • Robinson, J.M. and M.K. Trochim, An examination of community members', researchers' and health professionals' perceptions of barriers to minority participation in medical research: an application of concept mapping. Ethnicity and Health, 2007. 12(5): p. 521-539. • Shavers, V.L., C.F. Lynch, and L.F. Burmeister, Racial differences in factors that influence the willingness to participate in medical research studies. Annals of Epidemiology, 2002. 12: p. 248-256. • Yancey, A.K., A.N. Ortega, and S.K. Kumanyika, Effective recruitment and retention of minority research participants. Annual Review of Public Health, 2006. 27: p. 1-28. • Yates, B.C., et al., Testing an Alternate Informed Consent Process. Nursing Research 2009. 58(2): p. 135-139.