Improving Minority Recruitment into Clinical Trials
Transcript of Improving Minority Recruitment into Clinical Trials
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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
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RECRUITMENT COSTS ARE INCREASING
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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
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Continuing medical education for physician and staff
Printed educational materials for subjects
Incentives to patients
Use of local opinion leaders
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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
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• 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
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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
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Protocol issues Adequate Funding Site Selection Investigator Selection
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Time Constraints Lack of support staff Impact on doctor-patient relationship Concern for patients Clinician bias
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Loss of professional autonomy Obtaining consent Poor financial reimbursement Lack of interest in the specific research
question
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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
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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
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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
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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
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Examination of Community Members’, Researchers’ and Health Professional perceptions of barriers to minority recruitment (Robinson JM, 2007)
Cluster: Recruitment IssuesMinorities unaware of medical researchLack of cultural sensitivity in communicationsLack of resources to treat the uninsured if found to be sick Cluster: Patient concernsLack of awareness of benefits to participationSense that subjects only give and get nothingConcerns about signing ICF Cluster: Fears Fear of being a guinea pigFear of unknown
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Cluster: Psychosocial/socioeconomic issuesMore pressing survival problemsCultural beliefs/Religious beliefsMental illness, homelessness Cluster: History/past experiencesPrevious negative experienceLiteracy issuesMistrust due to discriminatory social/historical/legal
experiences Cluster: Resources/Financial considerationsLack of health coverage to reimburse medical interventions in
protocolPresentation at late stage for many minority patientsDismal past record of translating research into practice in
underserved community
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Cluster: Research System IssuesLack of adequate MD education in providing patient’s
information about trialsLack of incentive for overworked MDs caring for minorities
Inappropriate outreach methods Cluster: Researcher BiasMD fear of losing patientsPoor Relationship between medical institution and
communityLack of follow-up Cluster: Issues in Research Method, Design, ManagementNot linking research to what minority communities need Lack of minorities as PILack of bilingual researchers
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Outreach worker ResearcherIssues with methods Pt. concerns about
researchResearch system issues Research system issuesResources/ Financial Recruitment IssuesRecruitment Issues FearsPt concerns about research
Issues with methods
MD Bias Resources/FinancialHistory/past experiences MD BiasFears Psychosocial/
socioeconomicPsychosocial/socioeconomic
History/past experiencesR=.29
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Lay community Steering CommitteePt. 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 FearsHistory/ Past Experiences Resources/FinancialResearch system Issues History/past experiencesResources/Financial MD BiasRecruitment Issues Psychosocial/
socioeconomic
R=.11
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Lay community Outreach workerPt. concerns about research process
Issues with methods
Fears Research system issuesPsychosocial/Socioeconomic
Resources/ Financial
Issues in research methods
Recruitment Issues
MD Bias Pt concerns about research
History/ Past Experiences MD BiasResearch system Issues History/past experiencesResources/Financial FearsRecruitment Issues Psychosocial/
socioeconomicR=-.16
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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.
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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
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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
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Very few patients are aware that they are eligible to participateIn a clinical trial
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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
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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
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Poor (24%)Fair (29%)Good (33%)Excellent (14%)
Poor (1%)Fair (6%)Good (51%)Excellent (42%)
Attendee EvaluationsSelf-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
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Less likely (3%)No Change (22%)More likely (75%)
Attendee Evaluations
Likelihood of participating in a clinical trial:
n = 108
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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%
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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%
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Recruitment Strategy: Clinical Trial Alert Systems Configured the EHR to trigger an alert if a patient is
likely eligible for an ongoing clinical trialCTA is set to trigger only during clinical encountersIf 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
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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
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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
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Study specific websites Email Banner Advertising Chat rooms & forums Podcasts Search engine advertising
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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
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Creative Get noticed Offers news Compelling message Succinct message Meaningful to patient Use Emotion Pleasing colors Catchy study name
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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
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No more hand-me-downs:Research Designed for Children
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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.
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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.