2012 EDUCATIONAL BOOK - American Society of Clinical Oncology

Fiscal Year
women were invited to participate in person. The media
campaign proved more effective as evidenced by more
women consenting to participate and fewer no-shows in this
group compared with the clinic registry arm. 20 In the second
study, a randomized study of older black men in a screening
trial, three progressively intensive recruitment methods
were compared. Intervention arms received different combinations
of standard compared with enhanced mailings; baseline
information gathered via telephone, via mail, or during
a church session; reminders by telephone or mail; and
consent forms mailed or administered during a church
session. The most intensive of the intervention arms yielded
the higher enrollment compared with the control and other
intervention arms. 21 In the third study, enrollment in worksite
cancer prevention programs was assessed comparing
passive (telephone contact using telephone numbers provided
by the company) with active recruitment strategies (a
signup sheet). Enrollment and retention were lower among
employees recruited by passive methods than by active
methods. Passive methods, however, resulted in a representative
employee sample. 22 In the fourth study, the use of
minority outreach recruiters, a specialized recruitment
manual, and engagement of consultants for minority recruit-
KEY POINTS
Table 1. Minority-Based Community Clinical Oncology Program (MB-CCOP) Accrual, 2000–2009
No. of
Funded MB-CCOPs
No. of
Treatment Accruals
● Accrual to cancer clinical trials remains low and
largely unchanged despite initiatives and interventions
to increase rates beyond the estimated 5% to
10%.
● In the face of poorer prognosis, even lower rates of
accrual of minorities in cancer trials is compounded
by cultural-specific attitudes and sociodemographic
factors that must be addressed in addition to the
factors identified for other patients with cancer.
● An intervention approach that directly addresses
attitudes through use of a culturally appropriate
video has been shown to affect the intention of black
patients with cancer to enroll in therapeutic clinical
trials.
● Trial design factors, including eligibility criteria,
data collection, and quality, are among the systemwide
factors that also must be addressed to improve
accrual.
No. of Prevention
and Control Accruals
No. of
Overall Accruals
No. of
Minority Patients
ment failed to yield increases in recruitment of minority
participants in a prostate cancer prevention trial. 23 In the
final study, from the Southeast Cancer Control Consortium,
no improvement was found in enrollment of patients with
cancer into clinical trials after their intervention. This
intervention involved use of nurse facilitators, quarterly
newspapers, and health educators. 24
The problem is clearly complex, with multiple contributing
factors. Developing strategies that target factors that
yield the greatest effect is thus a challenge. Among black
patients, this is further complicated by the need to ensure
such strategies are culturally sensitive. This review describes
barriers to minority clinical trial accrual, a novel
approach to change black patients’ attitudes toward clinical
trial participation and strategies to enhance accrual.
Factors That Influence Black Patients’ Decisions to
Participate in Cancer Clinical Trials
A comprehensive review identified 150 distinct barriers to
accrual of underrepresented populations to cancer-related
clinical trials. The most frequently reported of these are
presented in Table 2. 13 Often, barriers are categorized
according to their source (e.g., patient, physician, or institution
or environment). A conceptual framework was developed
that proposes that these barriers may influence accrual
through their effects on awareness of trials, the opportunity
to participate, and the decision to accept or refuse participation.
The most frequently reported barrier related to
awareness of trials was lack of clinical trials education.
Education is crucial and can address other barriers, such as
mistrust of research and the medical system, perceived
harm, and fear. The most frequently reported barrier related
to opportunity to participate was physician attitudes and
patient eligibility. The most frequently reported barrier to
acceptance of enrollment was mistrust of research and the
medical system and costs of participation. 13
Black Patients’ Attitudes Toward Clinical
Trial Participation
Overall Minority
Participation, %
2000 8 425 358 783 427 55
2001 10 642 541 1183 672 57
2002 11 567 682 1249 949 76
2003 11 521 930 1451 1249 86
2004 13 673 467 1140 718 63
2005 13 709 428 1137 569 50
2006 13 684 393 1077 612 57
2007 14 805 776 1581 962 61
2008 13 895 733 1628 1051 65
2009 14 851 461 1312 830 63
Total (2000–2009) 14 851 461 1312 830 63
Courtesy of Worta McCaskill-Stevens, MD, MS, program director, MB-CCOP, National Institutes of Health.
154
BANDA ET AL
Many of the attitudes black patients have toward clinical
trial participation stem from historical abuses, such as the
U.S. Public Health Services Syphillis Study at Tuskegee,
and related concerns of ethical misconduct and mistrust. 6,25-27
In focus group interviews with 33 black patients and a black
moderator, most participants viewed clinical research negatively
and expressed concern they would be treated as a
guinea pig. They also believed black patients would not