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Improving Minority Participation in Multiple Myeloma Clinical Trials

Having multiple myeloma can be a life-threatening condition, particularly if you’re Black or African American. Research indicates that Black individuals are more than twice as likely to be diagnosed with and succumb to this form of blood cancer.

One of the contributing factors to this disparity is the underrepresentation of Black people in clinical trials, which are vital for understanding the safety and effectiveness of experimental treatments. Despite comprising a fifth of multiple myeloma diagnoses, only 4.5 percent of those in drug trials from 2003 to 2017 were Black. Nicole Gormley, MD, who co-authored a research paper on the topic, emphasizes the necessity of including diverse populations in trials to better assess potential impacts.

Gormley, the director of the FDA’s Division of Hematologic Malignancies, stresses the importance of diversity in clinical trials for a comprehensive evaluation of drug activity and side effects across all patient groups.

Anne Quinn Young, MPH, the chief mission officer of the Multiple Myeloma Research Foundation, points out several factors contributing to the lower enrollment of Black individuals in clinical trials, including:

Lack of information: Many Black cancer patients report that their doctors have not discussed the possibility of participating in a clinical trial, highlighting the existence of implicit biases that may hinder enrollment.

Distrust of the medical system: Historical injustices, such as the Tuskegee Syphilis Study, have fuelled mistrust among Black individuals regarding clinical trials. Despite these concerns, Gormley advocates for participation as an opportunity to access cutting-edge therapies and advanced care.

Financial barriers: Economic factors, such as income levels and treatment-related expenses, can pose significant obstacles for Black individuals considering participation in clinical trials.

Strict inclusion criteria: Eligibility requirements for trials may inadvertently exclude individuals based on race-related biological differences, underscoring the need for more flexible criteria.

The FDA’s new draft guidance in April 2022 aims to increase minority participation in clinical trials by encouraging collaborative efforts among healthcare professionals, industry stakeholders, and regulatory agencies.

Strategies recommended include broadening eligibility criteria, requiring diversity study plans, and appointing diversity officers to promote equitable representation in trials.

Tap into community-based medical centers: To reach a broader spectrum of participants, accessing local healthcare facilities may be more effective in engaging African American communities compared to traditional research centers.

Provide financial help: Initiatives offering support for expenses like childcare, transportation, and missed work can mitigate financial burdens that deter participation in clinical trials.

Study specific features of multiple myeloma unique to African Americans: Recognizing genetic variations linked to the prevalence of multiple myeloma among African Americans can inform trial design and treatment strategies tailored to this population.

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