In the evolving landscape of clinical research, the era of one-size-fits-all clinical trials is firmly behind us. Regulatory bodies and industry leaders alike recognize the necessity of diverse representation in trials to ensure that medical treatments are effective for all populations. While recent regulatory shifts have introduced challenges, the commitment to diversity remains a critical priority for ethical, scientific, and business reasons.
The FDA’s Commitment to Diversity—and Its Recent Rollback
The U.S. Food and Drug Administration (FDA) has long advocated for increased diversity in clinical trials. Recognizing the significant gaps in representation—especially among racial and ethnic minorities, older adults, and other underserved populations—the FDA issued progressive guidance starting in 2016. These measures included standardized race and ethnicity data collection, broader participant eligibility criteria, and improved recruitment strategies.
In June 2024, the FDA took a significant step forward by requiring sponsors to submit Diversity Action Plans for phase III and other pivotal studies. These plans mandated clear enrollment goals stratified by age, sex, race, and ethnicity and required sponsors to implement strategies for ensuring diverse representation.
However, in January 2025, President Trump signed an executive order leading to the removal of this guidance from the FDA’s website. While this regulatory rollback may present challenges, the industry’s commitment to diversity is unlikely to wane. This commitment was evident at the recent SCOPE 2025 conference where the topic of diversity was a prominent theme.
Companies face a dual challenge: adapting to shifting regulations while maintaining their focus on inclusivity. With public demand for equitable healthcare and the competitive advantages of diverse, data-rich trials, TriNetX foresees many organizations continuing to prioritize diversity, regardless of regulatory mandates.
Why Diversity in Clinical Trials Matters
The lack of diverse representation in clinical trials has historically led to treatments that are less effective or even harmful to certain populations. During the COVID-19 pandemic, disparities in clinical trial participation became particularly evident. Vulnerable groups, including racial minorities, older adults, and pregnant women, faced higher risks of severe illness, yet were often underrepresented in trials. Without adequate data from these populations, the efficacy and safety of treatments remained uncertain, exacerbating health disparities.
Strategies for Implementing Diversity in Clinical Trials
Ensuring diverse representation requires a multifaceted approach that addresses barriers to participation and enhances outreach efforts. Key strategies include:
- Setting Clear Enrollment Goals: Establishing demographic-specific enrollment targets ensures that trials reflect real-world populations.
- Leveraging Electronic Health Records (EHRs) and Real-World Data (RWD): Access to real-time demographic data helps researchers identify underrepresented populations and refine trial protocols to enhance inclusivity.
- Addressing Socioeconomic and Structural Barriers: Transportation assistance, flexible scheduling, and mobile trial units can reduce logistical obstacles for underserved communities.
- Community Engagement and Cultural Competency: Partnering with community organizations, offering multilingual resources, and training research staff in cultural competency can foster trust and improve recruitment.
- Monitoring and Adapting Recruitment Strategies: Real-time tracking of enrollment data allows researchers to make swift adjustments if specific demographic groups are underrepresented.
Enhancing Study Inclusivity through TriNetX
TriNetX plays a crucial role in promoting diversity in clinical trials. With access to over 295 million patient records from 209 healthcare organizations worldwide, TriNetX provides real-time demographic insights that support:
- Defining Diversity Benchmarks: Analytics enable researchers to set realistic diversity targets.
- Identifying and Addressing Restrictive Eligibility Criteria: Sponsors can assess inclusion/exclusion criteria to avoid inadvertently excluding key populations.
- Optimizing Site Selection: Researchers can pinpoint healthcare organizations with patient populations aligned with diversity goals.
The TriNetX Impact
Myelofibrosis Trial: Adjusting Restrictive Criteria
A sponsor consulted TriNetX to enhance a myelofibrosis trial’s inclusivity. Initial protocol analysis revealed that exclusion criteria disproportionately affected Asian and Hispanic populations:
- The exclusion of significant cardiac comorbidities reduced Asian eligibility by ~30 percent.
- The exclusion of gastrointestinal comorbidities reduced Hispanic eligibility by ~30 percent compared to only 4 percent for non-Hispanic patients.
By leveraging TriNetX data, the sponsor refined eligibility criteria to mitigate these effects, significantly improving cohort diversity.
Multiple Myeloma Study: Addressing Enrollment Barriers
African Americans have twice the incidence of multiple myeloma compared to white patients, yet they comprised only 4 percent of eligible trial participants while white participants made up 84 percent. TriNetX analysis revealed that:
- Black patients had longer times from diagnosis to initiation of novel therapies.
- They were less likely to receive triplet therapies, autologous stem cell transplants, or CAR-T therapy.
- Protocol exclusions based on serum creatinine levels disproportionately impacted Black patients.
By adjusting exclusion criteria (e.g., raising the creatinine threshold from 1.4 mg/dL to 2.0 mg/dL), eligibility for Black patients increased by 17 percent, aligning the trial population more closely with real-world disease demographics.
The Next Steps in Advancing Equitable Research
Despite regulatory uncertainties, the push for diversity in clinical trials is here to stay. Ethical imperatives, scientific rigor, and public demand all necessitate inclusive research practices. Organizations that embrace diversity not only contribute to health equity but also gain a competitive advantage by generating more robust, generalizable data.
By leveraging tools like TriNetX, integrating community-based recruitment strategies, and maintaining a steadfast commitment to equity, the research community can ensure that clinical trials truly serve all populations—regardless of race, ethnicity, age, or socioeconomic status. The future of medicine depends on it.
Learn more about TriNetX’s solutions to accelerate and optimize clinical trials and ensure more inclusive studies that benefit all.
About Joshua Hartman
As Director, Clinical Study Feasibility & Analytics, Josh leads a team of clinical experts in utilizing real-world data to enhance clinical trial design, feasibility, and site identification. His work reflects a deep commitment to advancing public health through data-driven insights
