Regional disparities affect Black patients’ access to immunotherapy clinical trials
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Unequal distribution of trial sites nationwide has led to inequitable access to cutting-edge immunotherapies among Black patients with advanced multiple myeloma, according to research published in JAMA Network Open.
Many states with the highest concentration of Black residents have limited or no centers offering clinical trials for chimeric antigen receptor T-cell therapies or bispecific antibodies, results showed.
Background
Prior research showed disparities in clinical trial participation among Black patients with multiple myeloma, according to Samer Al Hadidi, MD, MS, assistant professor in the myeloma center at University of Arkansas for Medical Sciences’ Winthrop P. Rockefeller Cancer Institute, and colleagues.
A study conducted by his group also suggested these same racial disparities exist in trials that supported the approval of CAR T-cell therapies in the United States.
“We hypothesized that this can be related to disparity in access to clinical trials,” Al Hadidi told Healio. “Given that CAR T-cell therapy and bispecific antibodies are showing promising results [for patients with] heavily pretreated multiple myeloma, we investigated whether access to those therapies is equal for African American patients.”
Methodology
The investigators conducted a cross-sectional analysis to evaluate data from clinical trials designed to evaluate CAR T-cell therapy or bispecific antibodies to treat multiple myeloma. The study included trials listed on ClinicalTrials.gov with at least one available trial site in the United States.
Investigators used a cutoff date of Jan. 31, 2022.
The analysis included 69 trials with more than 140 trial sites. More than half (59%) of trials were phase 1 and nearly all (96%) had industry sponsors.
Key findings
Approximately one-third (35.9%) of Black patients nationwide lived in a county with an open clinical trial for CAR-T or bispecific antibodies, results showed.
Seventeen states lacked a center offering an open CAR-T or bispecific antibody clinical trial.
Among the 10 states with the highest proportion of Black residents (range, 18.6% to 41.4%), three did not have an active trial site offering either of these immunotherapies. Three other states had three or fewer sites with active trials for CAR-T or bispecific antibodies.
Active trials in states with the highest proportion of Black residents were offered at sites in counties that had lower proportion of Black residents, Al Hadidi said.
Trial feasibility or availability of infrastructure did not appear associated with disparities in access because most states have at least one center that offers hematopoietic stem cell transplantation services, he added.
Investigators acknowledged study limitations, including the fact that Black patients who live in counties or states in close proximity to a center with an open trial may still have been classified as having limited access.
Clinical implications
The results suggest that efforts are needed to open trials in areas where patients need the treatment most, especially because multiple myeloma affects a higher proportion of Black individuals, Al Hadidi said.
“Many states with infrastructure capabilities do not have openings or very limited openings, whereas others have too many openings,” he told Healio. “Finding a center that is close to where patients live will help improve access.”
Making access to trials for these therapies “more homogenous and equally distributed” should be the goal of efforts to address disparities in access, Al Hadidi added.
“It is important to ensure that access to clinical trials is possible for Black patients,” Al Hadidi said. “Moreover, it is important to make sure that open trials serve patients with need and that centers are given equal opportunity to open trials of exciting therapies that serve patients close to where they live.”
For more information :
Samer Al Hadidi, MD, MS, can be reached at Myeloma Center, Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences, 4301 W. Markham St., #816, Little Rock, AR 72205; email: salhadidi@uams.edu.
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