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
WHY WE NEED TO TELL THIS STORY
RECRUITMENT COSTS ARE INCREASING
Study Recruitment Target
Actual # Recruited
H.Pylori testing eradication vs empirical acid suppressions
730 70Closed at 19
months
Early endoscopy vs. usual management in patients (+) for H.Pylori
800 272Closed at 18
months
H.Pylori testing and eradication with endoscopy of not improved versus early endoscopy
500 500Closed at 14
months
Foy, 2003
Continuing medical education for physician and staff
Printed educational materials for subjects
Incentives to patients
Use of local opinion leaders
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
• Local Data:Fox Chase Cancer Center (Northeast
Philadelphia)-data from 2004Catchment area: 18% Black, 6% Hispanic,
3% Asian, 71% WhiteMinority patient accrual: 8% Black, 2%
Hispanic, 1% Asian, 89% WhiteMinority patient recruitment: 6% Black,
<1% Asian and Hispanic each
Bruner, 2006
UMDNJ – University Hospital (UH) dataIn 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.
Minority Participation: UH Experience
Protocol issues Adequate Funding Site Selection Investigator Selection
Time Constraints Lack of support staff Impact on doctor-patient relationship Concern for patients Clinician bias
Loss of professional autonomy Obtaining consent Poor financial reimbursement Lack of interest in the specific research
question
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
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
Belief Blacks (%) Whites (%)
Risks equally shared by all racial/ethnic groups
34.6 40.5
Minorities bear most of the risk
25.2 5.2
Risks equally shared by rich and poor
22.8 57.8
Poor bear most of the risks
65.9 42.2
Rich bear most of the risks
11.3 0
Shavers, 2002
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
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
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
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
Outreach worker Researcher
Issues with methods Pt. concerns about research
Research system issues Research system issues
Resources/ Financial Recruitment Issues
Recruitment Issues Fears
Pt concerns about research
Issues with methods
MD Bias Resources/Financial
History/past experiences MD Bias
Fears Psychosocial/socioeconomic
Psychosocial/socioeconomic
History/past experiencesR=.29
Lay community Steering Committee
Pt. concerns about research
Research System Issues
Fears Pt. concerns about research
Psychosocial/Socioeconomic
Recruitment Issues
Issues in research methods
Issues in Research Methods
MD Bias Fears
History/ Past Experiences Resources/Financial
Research system Issues History/past experiences
Resources/Financial MD Bias
Recruitment Issues Psychosocial/socioeconomic
R=.11
Lay community Outreach worker
Pt. concerns about research process
Issues with methods
Fears Research system issues
Psychosocial/Socioeconomic
Resources/ Financial
Issues in research methods
Recruitment Issues
MD Bias Pt concerns about research
History/ Past Experiences MD Bias
Research system Issues History/past experiences
Resources/Financial Fears
Recruitment Issues Psychosocial/socioeconomic
R=-.16
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.
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
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
Very few patients are aware that they are eligible to participateIn a clinical trial
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
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
Poor (24%)
Fair (29%)
Good (33%)
Excellent (14%)
Poor (1%)
Fair (6%)
Good (51%)
Excellent (42%)
Attendee Evaluations
Self-reported knowledge of the clinical research process: Attendees who were not previously in a clinical trial
Before AWARE for All After AWARE for All
n = 66 n = 65
Less likely (3%)
No Change (22%)
More likely (75%)
Attendee Evaluations
Likelihood of participating in a clinical trial:
n = 108
Recruitment Strategy: Minority Principle Investigators Minority investigators are under-
represented among the pool of all active clinical investigators (Getz, 2008)
# Minorities who are PI
% minority PI
% of all PIs
White % of white MDs involved in research
% of all PIs
All clinical research
14,187 (out of 136,416)
10.4% 16.7% 70,702 (out of 420,846)
16.8% 83.3%
Gov’t funded
6,957 5.1% 19.1% 29,459 7.0% 80.9%
All industry funded research
11,595 8.5% 17.1% 56,393 13.4% 82.9%
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%
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
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
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
Study specific websites Email Banner Advertising Chat rooms & forums Podcasts Search engine advertising
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
Creative Get noticed Offers news Compelling message Succinct message Meaningful to patient Use Emotion Pleasing colors Catchy study name
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
No more hand-me-downs:Research Designed for Children
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.
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.