ealth disparities exist across racial and ethnic groups, income levels, and geographies. Recent heightened awareness of inequities in quality healthcare sparked a renewed social justice movement. DEI (diversity, equity, and inclusion) appears to be taken more seriously not only in healthcare, but across industries. It was in this charged environment that the US FDA released its final guidance on Enhancing the Diversity of Clinical Trial Populations in 2020 and updated Diversity Action Plan (DAP) draft guidance in 2024.

However, with change comes resistance, and some commitments were not long-lasting. 2024 found numerous commitments fading or even reversed. Laws or pending bills restricted DEI efforts in more than 30 US states. The US seems stuck in a tug-of-war between those for and those against DEI initiatives.

The 2024 updated DAP guidance document seeks to shift the imbalance and address health disparities and inequities across “geographic location, gender identity, sexual orientation, socioeconomic status, physical and mental disabilities, pregnancy status, lactation status, and comorbidity.” DEI is more than “race and ethnicity.” As the Association of American Medical Colleges defines it, DEI is about “the identities we carry,” recognizing that we do not all have the same starting place in healthcare, trying to correct the gaps, and “fostering belongingness.”

How Did We Get Here?

DEI has become a point of conflict. Opponents’ positions may stem from perceptions that DEI initiatives give certain people advantages over others. Allies believe that DEI approaches are a path to achieving quality healthcare for all people. Neutrals view DEI initiatives as nice to have but not critical.

What is the Alternative?

Admittedly, continuous conflict and resistance can be exhausting. However, what would be the impact on patients if we lack strategies to facilitate representative clinical studies and health research to uncover gaps in care or treatments? Such initiatives, called DEI or otherwise, require collaboration between industries, agencies, communities, and individuals. Without these relationships, a further degradation of trust in our current healthcare and clinical trial systems will continue.

Being “fatigued” by DEI misses the point. The goals are more representative clinical research and better healthcare for all.

Strength Through Partnerships

The FDA guidance and other supporting regulations will require more energy, focus, and dedication. Some experts advocate “building a safety net”; others propose that having an external support network in place with pre-identified resources creates a more prepared and better equipped organization to handle challenges.

Partnerships and collaboration present opportunities to strengthen purpose, multiply the impact on health equity, engage communities, and increase representation for better health outcomes. Local, national, and global organizations welcome participation and provide resources, such as:

• The PATIENTS Program
• Inspired Health Strategies: A Modern Approach to Patient Engagement
• Multi-Regional Clinical Trials Center (MRCT) of Brigham and Women’s Hospital and Harvard
• Patient-Centered Outcomes Research Institute (PCORI)
• The (US) National Academies of Science, Engineering, and Medicine
• European Patients’ Academy on Therapeutic Innovation (EUPATI)

Experts also recognize the need to recruit reinforcements, particularly those who reflect the populations not yet adequately served.

Future of DEI Beyond Words and Slogans

Focusing on the goal of health equity for all people, as distinct from catchy slogans and DEI terminology, will keep us chipping away at the challenges in front of us. If the issues are the recruitment of underrepresented people into clinical trials, healing the patient-provider relationship, figuring out how to identify and defeat rare diseases and cancer for all, then let us do what is needed to solve those issues and climb those mountains. As we hear so often from our partners, “There is a lot of work to do.” Change takes time. The time is now. Let’s recommit to being bold together.