March 31, 2023

Final Policy Brief of Four-Part Series Shines Light on Need for Diversity Within Autoimmune Clinical Trials

It has been well documented that in order for drugs and medical devices to be as safe and effective as possible, the trial population must reflect the broader treatment population. Ensuring that clinical trials are representative and diverse is essential for laying a foundation for improved scientific knowledge, ensuring health equity, and leading to effective standards of health care.

A variety of factors, from biological and genetic factors to behavioral to environmental factors, can lead to differences in how patients respond or adhere to treatments. The National Institute of Minority Health and Health Disparities (NIMHD) describes these differences as follows:

“Our health is a combination of physical and mental well-being, which is affected by our behavior, biology, environment, societal policies, and importantly, our lived experiences. The lived experiences of people in the United States vary based on their race and ethnicity, socioeconomic status (SES), geographic location, sexual orientation, gender identity, and other sociodemographic characteristics.”

However, clinical trials have not always achieved this diversity. Prior to the 1990s, women were excluded from clinical trials in the United States, and there was an over-reliance on male mice in research studies. Similarly, white patients have made up the majority of clinical trial participants. This exclusion and underrepresentation has had consequences, including within the autoimmune space. Specifically, the lack of diversity in autoimmune clinical trials has limited our understanding of autoimmune diseases and left us less equipped to provide treatments and interventions that work for everyone, regardless of sex, gender, race, or ethnicity.

Recognizing the significant impact that diversity has on the nation’s ability to improve autoimmune outcomes and advance health equity, the Society for Women’s Health Research (SWHR) developed the policy brief, “The Need for Diversity in Autoimmune Disease Research Trials: How Overlooking Diversity Hampers Knowledge and Impacts Outcomes.” Within the brief, SWHR reviews the historical exclusion and underrepresentation of certain populations from autoimmune clinical trials and examines three areas–women’s representation in rheumatoid arthritis research, pregnant and lactating populations in research, and the representation within certain systemic lupus erythematosus trials–where the trial population has not reflected the treatment population and how it has hindered our knowledge. The brief also makes policy recommendations for ensuring diversity in clinical trials is prioritized at the federal level and beyond.

This brief is the final in a set of four policy briefs that has been released by SWHR on autoimmune disease policy issues. Read the previous briefs:

Support for this educational program has been provided by Horizon Therapeutics. SWHR maintains independence and editorial control over program development, content, and work products.