Building a Framework for Equity Enrollment in Oncology Trials | Page 3
Figure 2.
Barriers Within the Accrual Process 8-20
Reduced awareness of cancer clinical
trials has been reported in African
American patients, individuals with an
annual income of less than $25,000,
or those without a college degree.
Yet many clinical trials are sponsored by private corporations, and
even government-funded trials face challenges in creating equity in
enrollment. And although multiple barriers to enrollment have been
identified and reported, documented solutions for breaking barriers
are few. Here we describe reported barriers to underserved oncology
patients and relate them to specific stages of a conceptual model of the
enrollment process. Understanding how patients approach enrollment
and where they encounter impediments may be useful for identifying
strategies for enrollment outreach in individual communities
or disease populations.
Conceptual Model of the Accrual Process ยป
The conceptual model of the accrual process describes three
fundamental steps required for patients to enroll in clinical trials:
awareness, opportunity, and decision-making. Patients accept or
refuse participation in a clinical trial only after being aware that the
study is being conducted and having an opportunity to participate.7
Given the opportunity to participate, an individual may seek additional
information regarding the potential harms or benefits of participation
The conceptual model serves as a framework to categorize barriers
based on their effects on awareness, opportunity, and decisions
Stage 1: Awareness of Clinical Trials
Not surprisingly, patient lack of awareness regarding cancer clinical
trials is associated with reduced participation in cancer clinical trials.8
Reduced awareness of cancer clinical trials has been reported in African
American patients, individuals with an annual income of less than
$25,000, or those without a college degree.8
Lack of knowledge about the origins of cancer is also a barrier
to enrollment.9,10 Contributing to the lack of awareness is a lack of
culturally appropriate information about cancer and cancer research.10
about participation.
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