Dr Vidal on the Need for Improved Clinical Trial Representation in Breast Cancer

Gregory Vidal, MD, PhD, associate professor, College of Medicine – Memphis, Department of Medicine, Division of Oncology, The University of Tennessee; medical oncologist, West Cancer Center, explains why clinical trials need to be more representative of the whole breast cancer population, in order to account for differences in biology and social determinants.

One of the biggest unmet needs within breast cancer involves producing more consistent outcomes based on the presentation of a patient’s disease, Vidal says. Although patients of color tend to present with more aggressive disease, such as triple-negative breast cancer, outcomes can vary across racial populations for those who present with the same type and stage of disease, Vidal adds.

To address this issue, clinical trials need to be more representative of the whole population, Vidal emphasizes. If 30% of the US population is comprised of people of color, enrollment to clinical trials should mirror this ratio, according to Vidal; this is needed to provide a clearer picture of how a diagnosis as well as drug efficacy and safety can vary across different races, because biology is different between these groups, Vidal adds.

If clinical trials can better account for different biology across a broader population, results can help physicians tailor treatment to achieve the best possible outcome for each individual patient, Vidal notes, adding that this is only possible if these different groups are properly represented in these studies. For example, if a Black patient’s disease does not respond to a drug in the same way a White patient’s disease may respond to it, this observation would allow clinicians to take a step back and further access what may be a more optimal therapy for an individual, Vidal explains.

Additionally, social determinants of health, including insurance coverage and personal finances, also play a role in patient outcomes. Patients of color tend to have less insurance or to be underinsured, resulting in lower levels of care, according to Vidal. Accounting for these differences in biology and social determinants is required to address existing unmet needs in this disease, Vidal concludes.