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Expert Outlines Strategies to Improve Access and Diversity in HR+/HER2- Breast Cancer Clinical Trials

  • Dr. Mabel Mardones emphasizes the critical importance of bringing clinical trials to community settings, highlighting the need for collaboration between pharmaceutical companies, academic centers, and community practices.

  • The expert calls attention to the significant underrepresentation of minorities in clinical trials, noting they comprise less than 5% of trial participants, prompting FDA prioritization of this issue.

  • Dr. Mardones advocates for dismantling provider biases, increasing diverse physician representation, and utilizing community resources to enhance trial accessibility for underserved populations.

A leading oncologist has called for transformative changes in how clinical trials are conducted and accessed, particularly for HR+/HER2- breast cancer patients, emphasizing the need for greater community engagement and diversity in clinical research.
Dr. Mabel Mardones, a board-certified medical oncologist and hematologist specializing in breast cancer at Rocky Mountain Cancer Centers, shared her insights during the Denver Regional Institute for Value-Based Medicine® event, highlighting critical strategies to improve clinical trial accessibility and patient outcomes.

Breaking Down Barriers to Clinical Trial Access

"We can't move the needle forward if we don't access clinical trials and if we don't bring them to patients in the community," Dr. Mardones emphasized. She outlined a three-pronged approach involving pharmaceutical companies, academic institutions, and community practices, stressing that most patients prefer receiving treatment within their communities rather than traveling to distant locations.
The current landscape of clinical trials faces significant challenges, with minorities representing less than 5% of all trial participants. This disparity has caught the attention of the FDA, which has made increasing diversity in clinical trials a top priority.

Addressing Representation and Trust in Healthcare

Dr. Mardones, drawing from her personal experience as a Latinx physician, highlighted the importance of physician diversity in building patient trust. "If you have a physician who represents a portion of that population, you get an immediate sense of trust," she explained, noting how speaking the same language as patients without requiring translators can significantly improve communication and care delivery.

Confronting Provider Biases and Expanding Access

A crucial aspect of improving trial access involves addressing inherent biases among healthcare providers. Dr. Mardones emphasized the importance of examining preconceptions about "ideal" trial candidates, noting that assumptions about patients' ability or willingness to participate in trials based on their socioeconomic status or location must be challenged.
The US Oncology Network, in collaboration with Sarah Cannon Research Institute, is actively working to increase diverse patient representation in clinical trials. This initiative includes:
  • Expanding community-based trial access
  • Utilizing nurse navigators and educators
  • Developing collaborative relationships with community organizations
  • Implementing more inclusive trial criteria
"It's really education, checking biases, making sure that community-based practices have access to those clinical trials," Dr. Mardones summarized, emphasizing that these efforts are essential for advancing cancer treatment and ensuring equitable access to cutting-edge therapies.
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Reference News

[1]
Improving Access and Outcomes in HR+/HER2– Breast Cancer Treatment
ajmc.com · Oct 22, 2024

Mabel Mardones, MD, emphasizes the importance of diverse representation in clinical trials and medical field to build tr...

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