2012 EDUCATIONAL BOOK - American Society of Clinical Oncology

A Critical Review of the Enrollment of Black
Patients in Cancer Clinical Trials
By Deliya R. Banda, PhD, Diane St. Germain, RN, MS, Worta McCaskill-Stevens, MD,
Jean G. Ford, MD, and Sandra M. Swain, MD
Overview: Although clinical trials represent a vital opportunity
for improvements in cancer treatment, data show that a
small proportion of patients with newly diagnosed cancer
participate in clinical research. Black patients continue to
have a worse prognosis for most cancers compared with other
patients of other races/ethnicities. Racial/ethnic- and agerelated
disparities in clinical trial accrual are also well documented.
The recruitment and retention of minorities in these
trials present an even greater challenge despite regulatory
efforts and initiatives to increase representation. Treatment
data from homogenous populations prevent us from under-
ACCRUAL TO clinical trials remains a longstanding
challenge, with 5% to 10% of patients with cancer from
the general population participating and even lower rates of
black patients participating. 1 For the general population,
the reasons are numerous, including lack of trial availability,
lack of physician engagement and awareness of available
trials, ineligibility, lack of insurance coverage, time
commitment, and lack of knowledge and misperceptions
regarding the conduct of clinical trials. 2-5 In addition to
these factors, a multitude of additional subgroup-specific
reasons have been reported, including a mistrust of the
research and medical system, awareness of historical clinical
research abuse, a lack of access to state-of-the-art care, a
higher incidence of comorbidities (resulting in higher rates
of ineligibility), religious and cultural beliefs that influence
attitudes toward clinical trials, economic issues, and logistical
concerns, such as child care and transportation. 6-11
Cancer rates and incidence are disproportionately higher
for some cancers in black patients compared with white
patients. 12 Inclusion of black patients in clinical trials is
therefore vital to gain an understanding of cancer biology
and response to treatment in this population and to provide
access to state-of-the-art care. Lack of access to state-of-theart
care contributes to advanced disease at diagnosis, treatment
morbidity, and decreased survival. 13,14 It may also
increase the rate of comorbidities that deem many of this
population ineligible for clinical trials. Among 235 black
patients screened for protocol eligibility, only 8.5% were
eligible. Patients were deemed ineligible because of comorbidities
(with respiratory failure, HIV positivity, and anemia
accounting for most), advanced disease stage, poor performance
status, premature death, and short life expectancy. 9
It is imperative that the rate of accrual of underserved
populations increase to maximize the generalizability of
results from clinical trials. Several efforts have been made
to increase accrual of underrepresented populations to
clinical trials. The National Institutes of Health Revitalization
Act of 1993 mandates the inclusion of women and
minorities in federally sponsored cancer clinical trials. The
aim is to conduct subset analyses to determine whether
there are differences in effect based on race and sex. The
National Cancer Institute (NCI) established the Minority-
Based Community Clinical Oncology Program in 1990,
standing therapeutic response and the true safety profile of
novel therapies. Patient-, physician-, and system-level factors
that affect trial participation have been extensively studied.
However, years of accrual data remain largely unchanged,
suggesting the challenge lies in effectively addressing these
factors. Furthermore, data showing that black patients tend to
have more advanced stage cancers at the time of diagnosis in
fact beg their overrepresentation on clinical trials. An inability
to successfully enroll diverse populations in clinical trials only
exacerbates racial/ethnic differences in cancer treatment and
survivorship.
which supports institutions with 40% minority population in
their catchment area to accrue racial minorities to treatment,
cancer control, and prevention trials. This program
has had successful accrual rates of 60% (Table 1). The
National Medical Association (NMA) developed I.M.P.A.C.T.
(Increase Minority Participation and Awareness of Clinical
Trials), an initiative to increase awareness, knowledge, and
participation of black physicians and patients in biomedical
research and clinical trials. There has been an increase in
minority accrual to clinical trials sponsored by the NCI
(Fig. 1). This may be attributable to enhanced efforts or an
increase in minority populations.
The University of California–Davis Cancer Center has
recently embarked on a national effort to boost clinical trial
recruitment of minorities as part of a major grant from the
National Center on Minority Health and Health Disparities.
15 This project, EMPaCT (Enabling Minority Participation
in Clinical Trials), will engage five other centers and
assess existing efforts to accrue minorities into trials. The
goal is to develop consensus on evidence-based accrual
models that can be adopted by cancer centers across the
country.
There has been a heightened understanding of the issues
as evidenced by the plethora of published studies documenting
the barriers to clinical trial enrollment in underserved
populations. 3,4,13,16-18 However, methods to increase minority
accrual elude clinicians largely because of the lack of
evidence-based strategies and practices in the literature.
One of the most extensive literature reviews identified only
14 articles that examined strategies to accrue underrepresented
populations to cancer clinical trials. Notably, the
efficacy or effectiveness of the strategies was evaluated in
five of the 14 studies. 19 The first was a randomized two-arm
study comparing the use of a media campaign involving
newspapers and fliers with a clinic registry strategy where
From the Washington Cancer Institute at Medstar Washington Hospital Center, Washington,
DC; Medstar Health Research Institute, Hyattsville, MD; Division of Cancer
Prevention, National Cancer Institute, Bethesda, MD; Johns Hopkins Center to Reduce
Cancer Disparities, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.
Authors’ disclosures of potential conflicts of interest are found at the end of this article.
Address reprint requests to Deliya R. Banda, PhD, 110 Irving St. NW, Suite CG-111,
Washington, DC 20010; email: Deliya.R.Banda@MedStar.net.
© 2012 by American Society of Clinical Oncology.
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