2012 EDUCATIONAL BOOK - American Society of Clinical Oncology

BLACK PATIENTS AND CANCER CLINICAL TRIALS
Fig. 1. Minority enrollment in National Cancer Institute clinical
trials, 2000–2010. Courtesy of Worta McCaskill-Stevens, MD,
MS, program director, Minority Based Community Clinical Oncology
Program, National Institutes of Health.
Abbreviations: CTEP, Cancer Therapy Evaluation Program; DCP,
Division of Cancer Prevention; RRP, Radiation Research Program.
benefit from clinical research because of racism and the
inability to pay for medical care. 7
Participants were asked specifically about the U.S. Public
Health Services study and were found to have misinformation
and misperceptions about the study. Many believed it
was a conspiracy and, as a result, expected that investigators
would be dishonest and not provide full disclosure of the
risks related to research. They also believed in other conspiracies,
such as the “creation” of HIV, military experiments
with Agent Orange, and Central Intelligence Agency
distribution of crack cocaine in black communities. 7
In another set of focus groups with black women, the
theme of trust also emerged. 28 Women were suspicious of
how clinical research was funded and expressed concerns
regarding the termination of programs that specifically help
the black community. 28 Focus group participants were presented
with a hypothetical phase III randomized clinical
trial in which adjuvant oral and intravenous chemotherapy
were compared. Some participants did not understand the
concept of randomization and lost interest in participating
because of a lack of choice of treatment arm. Other participants,
especially older women, were in favor of “natural”
treatments and stressed the importance of prayer or God as
healer. Most women were willing or at least open to considering
a clinical trial using an oral chemotherapy agent.
Physician Attitudes Toward Enrolling Black Patients
in Clinical Trials
Physicians play an important role in clinical trial accrual.
Their perceptions and support of clinical research influence
the discussions they have with patients and consequently
the patients’ decision to participate in clinical trials. A
survey of 166 black physicians revealed several challenges of
Table 2. Frequently Reported Patient Barriers to Minority
Accrual to Clinical Trials 13
Mistrust of research and medical system
Perceived harm
Cost
Patient demographics
Transportation
Lack of education regarding clinical trials
Time commitment
Fear
Family issues
participating in clinical research, 29 including additional
paperwork or telephone calls, masked drug assignment,
excess patient care costs, losing the patient from their
medical practice, and the potential effect of clinical research
on the managed care status of their medical practice. Although
most physicians surveyed (97%) believed clinical
trials were important, only 63% referred patients and 64%
encouraged patients to participate in clinical trials. This
validated the focus group reports of mistrust of the medical
system, lack of awareness of clinical trials, communication
with study staff, and economic issues as factors that play a
role in minority participation in clinical trials. 7,28,29
The Eastern Oncology Cooperative Group (ECOG) conducted
a pilot project with the NMA to determine whether
an outreach intervention program would increase minority
accrual. 30 The program consisted of five physician workshops
focused on the identification of physician and patient
barriers to minority accrual, potential solutions to address
these barriers, and the willingness of the participating
physicians to refer their patients to cancer clinical trials.
The two most frequent physician barriers for the NMA
physicians were lack of awareness and information about
clinical trials and lack of trust of the medical center sponsoring
the trial. Many had referred patients to a medical
center but received little to no information about them
thereafter; hence, this generated fear of losing their patients.
Moreover, this lack of communication was viewed
as a lack of respect for minority physicians. The ECOGaffiliated
physicians cited these barriers less frequently.
Regarding patient barriers, both physician groups cited
patient or family suspicion and fear. All agreed to the need
for patient education materials specifically designed for
minority patients. ECOG subsequently developed a culturally
sensitive patient educational brochure. In addition, a
physician newsletter and laminated pocket cards were developed
to provide clinical trial information, information
regarding the importance of minority participation in cancer
clinical trials, how to enroll patients in cancer clinical trials,
and other information that would enhance communication
between the NMA and ECOG physicians.
Additional Strategies to Enhance Accrual of
Black Patients
In addition to addressing patient and physician barriers,
it is crucial to examine clinical trial design and patient
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