New Research Finds Systematic Biases at Play in Clinical Trials

In the quest for medical advancements, Randomized Controlled Trials (RCTs) have long been held as the gold standard for clinical research. These trials are crucial for assessing the safety and efficacy of new treatments, providing researchers and healthcare providers with invaluable data. Despite their critical role, recent findings have raised concerns about the inclusivity and representativeness of these trials, suggesting that not all demographic groups are equally represented.

A recent study from Michigan State University found that people of color and white women are significantly underrepresented in RCTs due to systematic biases.

Randomized controlled trials (a scientific experiment that compares the effects of different treatments or interventions by randomly assigning participants to groups) or RCTs, are believed to be the best way to study the safety and efficacy of new treatments in clinical research. However, a recent study from Michigan State University found that people of color and white women are significantly underrepresented in RCTs due to systematic biases.

In a study published in the Journal of Ethnicity in Substance Abuse, researchers evaluated 18 RCTs conducted over the last 15 years that tested treatments for post-traumatic stress and alcohol use disorder. The researchers found that despite women having double the rates of post-traumatic stress and alcohol use disorder than men, and people of color having worse chronicity than white people, most participants were white (59.5%) and male (about 78%). The researchers found that the design and implementation of the RCTs contributed to the lack of representation of people of color and women. This effect manifested itself because trials were conducted in areas where white men were the majority demographic group and study samples almost always reflected the demographic makeup where studies occurred.

The researchers found that the design and implementation of the RCTs contributed to the lack of representation of people of color and women.

Additionally, those designing the studies seldom acknowledged race or gender differences, meaning they did not intentionally recruit diverse samples. The implications suggest that research studies should endeavor to include more demographic representation because marginalized groups have unique experiences from privileged groups, and when marginalized groups are poorly included in research, we remain uncertain about their experiences, insights, needs, and strengths.

Ensuring equitable representation in research not only enriches the validity and applicability of the study outcomes but also honors the ethical responsibility we hold to provide benefits equitably across all groups.

The findings from Michigan State University serve as a pivotal reminder of the need for diversity and inclusivity in clinical research. As the medical community continues to strive for precision medicine tailored to individual needs, it becomes increasingly clear that our clinical trials must evolve to reflect the diverse society we live in. Ensuring equitable representation in research not only enriches the validity and applicability of the study outcomes but also honors the ethical responsibility we hold to provide benefits equitably across all groups. Moving forward, it is imperative that trial designers and sponsors take intentional steps towards inclusivity, transforming how we gather and interpret health data in a way that truly benefits everyone.

About Women’s Cancer Research Foundation:

The Women’s Cancer Research Foundation (WCRF) is one of the most active research organizations in the nation. We are dedicated to studying and evaluating novel treatments for women afflicted with breast, ovarian, endometrial, and cervical cancers. The WCRF persistently endeavors to make a difference in women’s lives by offering them hope, strength, and progress.