Post on 29-Mar-2015
Clinical Cancer Research in a Fail-safe Hospital:
Mitigating Myths Of Mistrust
Steven Wolff, M.D., Meharry Medical College
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 .
Underrepresented Groups
Rural patientsPatients of lower SESAdolescents and young adultsOlder patients (65+ years),
especially with co-morbiditiesAA men, Hispanic, Asian, Native
American women and men
Barriers to Accrual
• National health policy
• Local research infrastructure
• Providers of health care
• Research studies
• Patient based issues
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.”
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
Barriers to Accrual
JG Ford et al. Cancer January 15, 2008 / Volume 112 / Number 2
Awareness
Opportunity
Acceptance/Refusal
AwarenessBarriers/
Promoters
Interventions
OpportunityBarriers/
Promoters
Moderators/Sociodemographic
Factors
Measuresof
Success
Acceptance/RefusalBarriers/
Promoters
StudyDesign
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
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
Barriers to Opportunity
STUDY BASED• Disease appropriate studies• Stage appropriate studies• Co-morbidity eligibility• Schedule testing appropriateness• “Generalizability” of results
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
Nashville General Hospital Meharry Medical College
Fail-safe public hospital with large proportion of uninsured and underinsured
patients serving as the main clinical campus
Patients at the NGH
Renal Disease Heart Disease
HTN
DM
Hep/Liver Dis.
Thyroid Dis.
DVTGI + Pancreatitis
GenitourinarySleep Apnea
ArthritisPsychiatric Dis. Active Infections2ndary cancers
Tobacco use
ETOH Use
Elicit Drugs
Pulmonary Dis.Hyperlipidemia
Co-morbidities
Renal Disease
Heart Disease
HTN
DM
Hep/Liver Dis.
Thyroid Dis.
DVT
HIV/AIDS
GI + Pancreatitis
Genitourinary
Sleep Apnea
Arthritis
Psychiatric Dis.
Active Infections
2ndary cancers
Tobacco use
ETOH Use
Elicit Drugs
Pulmonary Dis.
Hyperlipidemia
Patients at the NGH
Patients at the NGH
Patients at the NGHRe
nal D
isea
se
Hea
rt D
isea
se
HTN DM
Hep
/Liv
er D
is.
Thyr
oid
Dis
.
DV
T
HIV
/AID
S
GI +
Pan
crea
titis
Gen
itou
rina
ry
Slee
p A
pnea
Art
hriti
s
Psyc
hiat
ric
Dis
.
Acti
ve In
fecti
ons
2nda
ry c
ance
rs
Toba
cco
use
ETO
H U
se
Elic
it D
rugs
Pulm
onar
y D
is.
Hyp
erlip
idem
ia
0
10
20
30
40
50
60
70
Percent of Patients with Co-morbidities
NGH
VU
Patients at the NGH
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
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.
Initial PessimismGeneral concept that underserved or
minority patients would not participate in clinical research.
“If you make it, they still won’t come”
Clinical Trial Accrual Process
Clinical Trial Accrual Process
1. Patient centric environment of trust2. Program emphasis on clinical trials3. Prospectively identify subjects for clinical trials4. Screen each cancer patient5. Proactive and not reactive6. Evaluate patients for study requirements7. Plan testing as part of the primary effort8. Discuss clinical trials early in the course of care9. Support of clinical staff for clinical trials
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
Clinical Trial Accrual Process
Clinical Trial Accrual Process
Clinical Trial Accrual Process
Clinical Trial Accrual Process
Clinical Trial Accrual Process
Confounders and Bias
1. Fail-safe hospital with most patients having no other health care alternative
2. Relatively small number of patients
3. Academic center with dedication for teaching and clinical research
4. Adequate staff resources
5. Care in an HBCU with well-established position in the community
It Takes a Program to Make a Program