As I was straightening up my office last week in a fit of spring cleaning, I came across the 2022 National Academy of Sciences report, Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups. One line in particular struck me: “The overarching goal of the US investment in biomedical research is to improve the health and well-being of the entire US population.” I couldn’t help but reflect on how that once-unifying aspiration—long supported by federal leadership and widely embraced across the research community—now feels precarious. In just a matter of months, what was a shared, nonpartisan commitment to inclusive clinical research has been diminished, if not entirely upended, by shifts in policy and political will. 

The report proceeds to outline how a lack of representation “risks undermining the overall goals of clinical research.” It goes on to clearly articulate “the costs of maintaining the status quo,” such as how a lack of representation limits the generalization of clinical research findings to the US population, compounds health disparities, and comes at a cost of hundreds of billions of dollars. These findings are as true today as when this report was published in 2022.  

The times we are living through require that we center ourselves and those around us on validated facts, professional experiences, and deeply held values and beliefs that first inspired our commitment to inclusion and diversity in clinical research. For me, this commitment is grounded in a health justice mindset, one that emphasizes the importance of addressing the root causes of health inequities and ensuring that all communities have an equal opportunity to thrive. This foundational belief, supported by institutions like the American Association of Medical Colleges (AAMC), is something that cannot be altered by federal policy or legislative actions.  

No matter where one sits within the health care ecosystem, now is the time that, as patient engagement and advocacy leaders, we must elevate facts and share our knowledge about the power of inclusion and its impact. One example of this impact is a patient advisory board that VOZ convened on behalf of a client to gain informed consent form (ICF) insights. The ICF described a rash as presenting as red or pink. Insights from patients with black and brown skin were that the rash presented as brown, gray, and sometimes purple, with one advisory board member sharing that they would not choose to participate in the trial as it did not appear to be designed for people like them. These insights led to modifications in the ICF and protocol language for this and other dermatological studies and placed a fine point on the importance of inclusion to developing safe and effective medicines for everyone.

There is no doubt that we are facing tremendous headwinds on the path to health justice. As advocates for patient engagement and co-creation, this is our time to do what we have always done—innovate, lead, and advocate for further inclusion; and to draw strength from each other and our shared vision of what biomedical research can and should be—a pathway to improving the health and well-being of all people.

–Ronnie Todaro, President & CEO