Disparities in the Availability of Cancer Clinical Trials: A Multi-level Analysis
Participation of minority populations in cancer clinical trials is vital to ensure generalizability of
the results generated, facilitate discovery of novel therapies and therapeutic responses that are
particularly relevant to traditionally underrepresented populations, and ensure equitable access
to new and promising treatments. Yet more than twenty years after Congress mandated that the
NIH ensure `sufficient and appropriate' participation of minorities in clinical research, the
participation rate of many minority populations remains substantially lower than the composition
of the overall US population. Disparities in access to cancer clinical trials are a chief barrier to
reducing disparities in trial participation. Thus it is critical to understand the role that geographic
variation plays in driving disparities in access to cancer clinical trials if we are to design and
target effective interventions to improve minority participation in such trials. Prior studies have
had limited success in teasing apart the complex mix of site- and health care system-level
factors that influence the availability of different types of cancer clinical trials for minority
populations for two chief reasons. First, we currently lack a comprehensive database of
sufficiently detailed trial-level characteristics or information about the locations where trials are
launched because of the difficulty in synthesizing such information from multiple sources using
traditional record linkage methods. As such, prior studies evaluating disparities in the availability
of cancer clinical trials have been importantly limited in the range of factors examined and the
number and type of trials studied. Second, cancer clinical trials are often launched at multiple
sites that operate within larger healthcare systems, and individual recruiting sites often
participate in multiple trials, which pose methodological challenges to disentangling the
associations between various trial-, site-, and health care system-level factors on cancer clinical
trial availability. We propose to address these challenges by integrating information from
multiple sources using advanced record linkage methods and applying sophisticated modeling
techniques to analyze the resulting multilevel data. The proposed study will improve
understanding of how the availability of cancer clinical trials varies across geographic settings
and the clinical trials portfolio, which could help target interventions and policies to address
disparities in access to the areas most in need. This project will also lay the scientific
foundation for a planned future study to predict enrollment of patient populations traditionally
underrepresented in clinical research in publicly funded cancer clinical trials.
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