Clinical trials are research studies performed on humans to help evaluate a new medical treatment, drug, or device. However, just like a disease, there is always a possibility that each of these medical products may have different outcomes for specific groups.
The FDA’s Commissioner of Food and Drugs-Dr. Stephen M. Hahn- utilizes the COVID-19 virus as a perfect recent example. The COVID-19 virus affects various groups (age, sex, race, ethnicity, those with existing medical conditions, etc.) within the population differently. Thus, diversity in the clinical trials working to develop COVID-19 treatments and vaccines is crucial so that researchers can ensure that everyone can be protected against the virus (and for these groups to understand the risks and benefits that pertain to them).
However, the necessity for diversity does not only extend to COVID-19 but all types and forms of clinical trials. The people within clinical trials must represent the general population that will potentially use the medical product/treatment in question. It helps ensure that researchers are confident that the benefits will apply to the larger population. Or it can help them establish any risks or side effects that may pertain to specific groups. A lack of diversity presents an obstacle in understanding the effectiveness of medical products and treatments. What can we learn about the overall performance of a medical product/treatment if we only have data that pertains to a specific non-inclusive group? Therefore, the FDA recommends that clinical research companies design and execute their clinical trials to include those with different demographic characteristics (age, sex, race & ethnicity, religion, geographic area, income, education level, etc.) and non-demographic characteristics (those with organ dysfunctions, comorbid conditions, disabilities, and groups with uncommon diseases or conditions).
Despite the stressed importance of diversifying clinical trials, people from various racial & ethnic groups (and other diverse groups) are still underrepresented in clinical research. Thus, it is also highly encouraged that medical research companies keep in mind the issues that may account for the lack of diversity. This includes:
- Lack of information: Many may not realize that they can qualify to participate in studies. Or they may feel nervous or timid because they don’t know how the clinical trials process works. Thus, this makes them more vulnerable to hearing and believing misinformation.
- Lack of trust: Unfortunately, in the past, there have been many cases where specific ethnic groups were deceived during clinical trials (i.e., the Tuskegee Syphilis Study). These occurrences have made certain groups more cautious and skeptical.
- Lack of resources: Unfortunately, there are many cases where financial and transportation barriers may make it difficult for someone to volunteer in a clinical trial. Not everyone can take time off work, have free time or availability in their overall schedule, travel to the facility, or pay for the care they will receive.
In keeping all these issues in mind, clinical research companies must make an effort to broaden diversity in their clinical trials. Without diversity, it impedes our ability to generalize study results and make medical advancements that benefit the overall population. That is why here, at FOMAT Medical Research, our mission is to diversify clinical trials innovating healthcare for underrepresented populations while ensuring that Good Clinical Practice standards and ethics are upheld. We understand that it is essential that we actively transform/create a better system to ensure diversity in clinical trials, and we believe in innovating healthcare through diversity.
For more information related to Clinical Trials, Diversity in Clinical Trials; read more: www.fda.gov (Dr. Stephen M. Hahn’s statement), www.fda.gov