Microsoft PowerPoint - Session 1

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Microsoft PowerPoint - Session 1 Powered By Docstoc
					    The Science of Minority
    and Underrepresented
      Population Accrual
           Steven Wolff, M.D., Meharry Medical College
  Derek Raghavan, M.D., Ph.D., Cleveland Clinic (Session Chair)
Jean Ford, M.D., Johns Hopkins Bloomberg School of Public Health


                      Session 1.2




      Cancer Clinical Trials
•
20% of adults are eligible for a cancer clinical trial.

•                      participate.
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.

•
Those who participate are more like to be insured
with higher socioeconomic status.
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




  Human Cancer Cell Pathway
  Age Adjusted Death Rate




Colo-
Colo-rectal Cancer Mortality Disparity
Breast Cancer Mortality Disparity




The Issues Causing Health Disparity




              Genetic
 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
          y         g      p




      Cancer Clinical Trials
• What are barriers & promoters for participation of
  underrepresented populations in cancer trials?
• What effects do healthcare providers have on
  recruitment of under-represented populations?
• What strategies are efficacious?
• What measures of success have been used?
• What methods have been used to study
  recruitment strategies?
    Barriers to Accrual

• National health infrastructure
                  policy
• Local research care
• Providers studies
            of health
• Research issues
• Patient based



    Barriers to Accrual




    JG Ford et al. Cancer January 15, 2008 / Volume 112 / Number 2
         Barriers to Accrual
“The eligible studies identified 150 distinct barriers
to accrual to cancer-related trials, including 124 barriers to
accrual to therapeutic trials only, 26 barriers to accrual to
       ti   ti l    l     d    barriers to accrual to both
prevention trials only, and 32 b i       t         l t b th
therapeutic and prevention trials.

The studies reported 8 barriers to awareness, 88 barriers to
the opportunity to participate, and 44 barriers to acceptance of
enrollment into a cancer related trial.

Among these, 79 barriers were relevant at the patient level, 37
were relevant at the provider level, 25 were relevant at the
study design level, and 8 were relevant at the healthcare
systems level.”

         JG Ford et al. Cancer January 15, 2008 / Volume 112 / Number 2




    Barriers to Opportunity
1) HEALTH POLICY
   • Access and affordable health care
   • Promotion of clinical trials as routine
   • Available trial facilities
   • Resource support from third parties
   • Trial oversight and organization
   • Harmonization and efficiency
       Barriers to Opportunity
2) LOCAL INFRASTRUCTURE
   •   Leadership commitment for clinical trial accrual
   •   Academic
       A d i credit  dit
   •   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




       Barriers to Opportunity
3) 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
     Barriers to Opportunity
4) STUDY BASED
 •   Disease appropriate studies
 •   Stage appropriate studies
 •   Co-morbidity eligibility
 •   Schedule testing appropriateness
 •   “Generalizability” of results




     Barriers to Opportunity




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




         JG Ford et al. Cancer January 15, 2008 / Volume 112 / Number 2




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




     JG Ford et al. Cancer January 15, 2008 / Volume 112 / Number 2




Summary of Barriers to Clinical Trials




               Ford JG, et al., Cancer. 2008; 112:228-42.
  Safety Net Hospital
               2001-
Barriers Noted 2001-2004
•   Co-morbidity                                                                        27%
•   Eligibility                                                                         23%
•   Performance status
    P f            t t                                                                  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




      Patients at the NGH

                                            Co‐morbidities

                                                                                                       Renal Disease
                                                                                                       Heart Disease
                                                                                                       HTN
                            Hyperlipidemia Renal Disease Heart Disease                                 DM
          Pulmonary Dis.                                                                               Hep/Liver Dis.
                                                                                                       Thyroid Dis.
     Elicit Drugs
                                                                   HTN                                 DVT
                                                                                                       HIV/AIDS
                                                                               DM                      GI + Pancreatitis
           ETOH Use
                                                                                    Hep/Liver Dis.     Genitourinary
                                                                                                       Sleep Apnea
                    Tobacco use                                                     Thyroid Dis. DVT   Arthritis
                                                                                     HIV/AIDS          Psychiatric Dis. 
                                                                                                       Active Infections
                                                                                 GI + Pancreatitis     2ndary cancers
                                                                               Genitourinary           Tobacco use
                                                                   Arthritis                           ETOH Use
                           2ndary cancers      Psychiatric Dis.          Sleep Apnea                   Elicit Drugs
                                     Active Infections                                                 Pulmonary Dis.
                                                                                                       Hyperlipidemia
          Patients at the NGH




Social Barriers to Clinical Trials
 “Even when they have health insurance, people
 with low income often have more difficulty gaining
                            need.
 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
                           care
 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.”
 Targets of Barriers to Clinical Trials
  1. Opportunity
     a)   Practices/investigators with research resources
     b)
      )   Commitment to clinical trials
     c)   Accountability for accrual
     d)   Availability of appropriate studies
  2. Awareness
     a) Recruitment and navigation
     b) Peer group mentoring/support
         p
  3. Acceptance
     a) Patient/subject/ culturally sensitive
     b) Logistically suitable studies
     c) Cost consideration and system support




           Goals of the Session
• Focus on solutions to advance cancer trial accrual
• Present existing and emerging, evidence-based trial
        l t t i                  i t f ti t
  accrual strategies among a variety of patient
  populations, settings, cancers, and trials
• Promote innovative strategies to common challenges
  in clinical trial accrual, including recruiting and
  retaining minority and under-served populations
• Identify recommendations for future research
• Provide a forum for idea exchange among researchers
  conducting cancer trial accrual studies and those
  implementing successful strategies

				
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