Clinical trials are studies conducted by researchers that aim to help evaluate the safety and efficacy of new treatments or medications. They play an important role in improving patient care by advancing medical knowledge. There are many different types of clinical trials, and they go through different phases. They are closely regulated by the FDA to ensure patient safety. Clinical trials are a critical component of advancing breast cancer treatment.

When a specific ethnic or minority group is underrepresented in clinical trials, this can be detrimental to the advancement of treatment options and significantly researchers are able to gain regarding factors or considerations that are specific to that group. It is imperative that we increase representation and diversity in clinical research, allowing critical insight into the complex differences that may exist among these groups and promoting improved outcomes.

If data including minority patients is lacking in clinical trial databases, this can limit the potential benefits of personalized medicine for minority communities. Increasing minority participation in clinical trials can provide valuable insights into cultural and social factors that affect healthcare decision-making and adherence to treatment regimens.

Increasing Clinical Trial Participation

While clinical trials play a huge role, it is crucial that participants in these trials appropriately represent the population. So crucial, in fact, that the FDA issued guidance in 2019 urging pharmaceutical companies to increase clinical trial enrollment of underrepresented populations. Diversifying clinical trial participation helps researchers better understand the risks and benefits across different groups and reduce health care disparities.

Limited access is one of the major barriers to involvement of underrepresented groups in clinical trials. Eli Lilly and Company recognizes that diversity in clinical trials is a critical part of ensuring medications are effective for those that use them, and  they strive to achieve diverse representation in their clinical trials.

Click here to learn more about an ongoing breast cancer clinical trial, determine if you are eligible, and do your part to increase diversity in clinical trials and advance estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-) breast cancer research.

Disparities in Breast Cancer Clinical Trials

Lack of clinical trial diversity is a barrier to the advancement of breast cancer treatment. Black women specifically are largely underrepresented in clinical trials. In fact, Black patients make up less than 4% of enrolled patients for specific cancer treatments. Some factors that may explain the low participation rate include access to care, finances, lack of awareness, and patient uncertainty. If you are willing to participate in a clinical trial, but have concerns, speak with your health care provider about your options and the risks and benefits of participation. Your provider can also answer any questions you have.

Choosing to participate in a breast cancer clinical trial requires making the important decision to invest in your health and the health of other patients with breast cancer. When you volunteer for a clinical trial, you become a vital contributor to the research process. Your participation may also help researchers work toward understanding and improving health disparities.

Making your decision can come with an overflow of emotions. Understanding the role clinical trials play in the advancement of healthcare may help make your decision easier. If you choose to participate in a clinical trial,

If you or a loved one have early-stage ER+/HER2- breast cancer and have had surgery to treat it, click here to learn more about whether a clinical trial may be an option for you.

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References

• S. Food & Drug Administration. Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry
• ACS Journals. Addressing racial/ethnic disparities in cancer clinical trials: Everyone has a role to play
• American Association for Cancer Research. Disparities In Clinical Research and Cancer Treatment
• Journal of Racial and Ethnic Health Disparities. Increasing Clinical Trial Participation of Black Women Diagnosed with Breast Cancer