Cancer Clinical Trials

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


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


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 NGHRe

nal D

isea

se

Hea

rt D

isea

se

HTN DM

Hep

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er D

is.

Thyr

oid

Dis

.

DV

T

HIV

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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


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

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

Cancer Clinical Trials

Documents

Transcript of Cancer Clinical Trials