Clinical trials assess the effects of interventions, such as medications, devices, surgical procedures, dietary plans, behavioral strategies, and lifestyle interventions, on biomedical or behavioral health-related outcomes. It is thanks to clinical trials that we can determine if new interventions are safe, effective, or are in other ways beneficial. They give us ways to detect diseases early, when they are potentially more treatable, or ways to prevent them altogether. Clinical trials can also evaluate methods of improving the quality of life of individuals grappling with an illness or chronic medical condition. When conducting a clinical trial, it is crucial to account for different populations’ diverse experiences and exposures. Research must be inclusive of various racial and ethnic backgrounds, as well as sexual and gender identity and socioeconomically disadvantaged populations. There are also therapies in which specific populations are required. This blog post examines the importance of diversity in clinical trials and how it relates to gene-specific therapies.
Why Participate in a Clinical Trial
Participating in clinical trials is voluntary and there are many reasons why someone may choose to take part in one. Some participants volunteer because it allows them to receive experimental treatments that may help a life-threatening or debilitating disease with no standard treatments or none that were successful on that patient. Other participants want to contribute to science and help others with similar health issues. Additionally, there are new interventions and treatments such as smoking cessation and weight management that have yet to receive approval from the U.S. Food and Drug Administration (FDA). These may undergo testing to determine if the intervention is beneficial in treating a condition in cases where current treatments are unavailable, ineffective, cause undesirable side effects, or only provide symptomatic relief without a cure. Regardless of the reason one may choose to participate in a clinical trial, there is no doubt that their contribution is significant to breaking ground in research.
Why Diversity & Inclusion is Important
Not everyone experiences common diseases the same way. Including various types of people of all backgrounds in clinical trials is essential so all communities can benefit from medical advancements. Characteristics that may affect the risk and probability of developing a disease, encountering long-term health consequences, and responding to treatments include age, sex, pregnancy status, life expectancy, lifestyle, environmental conditions, genetic variation, and underlying medical problems.
Clinical trials that exclusively rely on a subset of a population result in shortcomings that undermine the understanding of specific diseases, preventions, and effective treatments. This narrow data can skew information crucial to improving healthcare quality, counseling at-risk patients, and ideal treatment responses. Most importantly, it can hinder the development of more effective medications and treatments. Researchers and clinicians must be thorough and diligent when accounting for their target population.
An example of this is during the early stages of the COVID-19 pandemic in which racial and ethnic minority populations were disproportionately affected. These populations, which included African Americans, Hispanics/Latinos, American Indians/Alaska Natives, and Native Hawaiians and Pacific Islanders, saw increased cases of hospitalizations and deaths. When the COVID-19 vaccine was developed, the trials needed to include representation in all populations to determine its effectiveness and safety. By employing inclusive measures, researchers demonstrated these characteristics to be similar across all racial and ethnic populations, thus also increasing public reassurance that the vaccine was effective and safe for use.
Diversity in Gene-Specific Therapies
Research on genetics and genomics has primarily focused on populations of European descent. Any benefits found using this research greatly underrepresent many populations, affecting diagnosis accuracy and efficiency, detection of diseases, and rational drug designs. Similarly, including underrepresented populations holds potential benefits for global initiatives aimed at identifying disease-causing variants. African populations have the most genetic diversity along with South Asians. They also have the most loss-of-function variants, which can aid in understanding multiple mutations. Even with a high degree of similarity between any two human genomes, enough differences are present so that it is not appropriate to use a limited number of genomes to represent the world’s populations. If the scientific and healthcare communities want to better define a person’s risk of developing a specific disease, looking at various genomes is paramount. This way, researchers can design clinical management strategies and other medical therapies that benefit specific populations.
Conclusion
Diversity and inclusion in clinical research are important for equitably advancing healthcare and treatment to different populations across the globe. Including participants of diverse ethnic and racial backgrounds as well as socioeconomic status helps researchers better understand how diseases unfold, which responses to treatment are best, and what a person’s overall health contributes to their experience of a disease or intervention. In addition, representative diversity in research builds trust and inspires involvement in communities, ensuring that research outcomes are more valid and meaningful. It strengthens the science and advances health equity and healthcare outcomes for all, which is what being in healthcare is all about.
