Disruptions threaten progress in inclusive clinical trials and health equity

JMIR Publications today featured a critical new story in its News and Perspectives section examining the recent waves of disruption to inclusive clinical trials and the emerging strategies to keep health equity on track. The article, "Keeping Clinical Trials on an Inclusive Track," authored by Virginia Gewin, details how recent shifts in federal policy and funding have impacted hundreds of trials designed to study disease burdens in underrepresented populations.

The report highlights the harrowing case of Dr. Dinushika Mohottige, whose NIH-funded study on kidney disease in Black individuals was abruptly terminated in early 2025 following a White House Executive Order targeting DEI programs. While funding was eventually restored after a lawsuit, the 10-month delay in recruitment resulted in potential participants falling seriously ill or passing away.

The human and economic cost of underrepresentation

The feature underscores a systemic crisis in medical research:

• Disruption at Scale: In 2025 alone, 383 clinical trials were disrupted, affecting more than 74,000 participants. Trials focusing on infectious diseases, prevention, and behavioral interventions were hit the hardest.

• The Diversity Gap: Research shows that fewer than 20% of drug trials conducted between 2014 and 2021 had data relevant to the specific benefits or side effects for Black patients.

• A Multi-Billion Dollar Problem: Experts warn that failing to characterize drug efficacy across diverse ethnic groups could cost hundreds of billions of dollars in reduced life expectancy and disabilities over the next 25 years.

Bridging the gap: Digital tools and patient advocacy

To counter these structural barriers, the report explores two primary avenues for maintaining inclusive recruitment:

• Digital Innovation: Clinicians are increasingly using AI and machine learning to mine electronic health records (EHRs) for ideal participants and utilizing social media for culturally tailored outreach. However, experts like Dr. Sonia Anand warn that a digital literacy gap and a lack of trust in data privacy among non-White individuals could inadvertently widen the health equity gap if not managed carefully.

• Community-Centered Design: The article advocates for participation-to-prevalence ratios and the inclusion of patient advocates from day one. Robert Sanchez, a patient advocate working with Dr. Mohottige, emphasizes the need for a human-centered approach to data, stating, "Numbers need to have a soul."

A call for long-term investment

The report concludes that while reaching diverse populations involves higher up-front costs, the long-term impact on public health and economic stability is undeniable. By leveraging community partnerships and refining digital tools, the medical community can move toward trials that accurately reflect real-world populations.