News By: Emily Norris

Institutional barriers remain a key driver of health inequities based on race, ethnicity, age and gender, particularly in the United States. The U.S. Food and Drug Administration has taken steps to address these disparities in clinical trial study enrollment over the past two decades, including recent draft guidance issued in June 2024, which mandates diversity action plans for all Phase II and III registrational studies. These regulatory efforts are a helpful step, but much remains to be done in this space.

For too long, clinical trials have failed to adequately represent the diverse patient populations that will ultimately take the drugs and treatments being tested. This has created gaps in understanding how different people may respond to therapies based on factors like age, gender, race, and ethnicity. The lack of diversity in clinical research means medicines are not studied in representative populations, which can negatively impact healthcare decision-making and patient outcomes. 

Consumers of popular culture in the 1960s and 1970s preferred their artificial intelligence (AI) to come with overtones of danger, if not outright world domination, judging by small- and large-screen science fiction artifacts ranging from episodes of the original Star Trek series to movies like 2001: A Space Odyssey and Colossus: The Forbin Project. All these decades later, amidst a burst of new applications of AI to tasks large and small—including in the realm of clinical research—the questions behind most people’s concerns about the technology, whether stemming from mild curiosity to serious opposition, may seem downright prosaic in comparison to those raised in earlier times. 

Negotiate and collect fair payment for your work by understanding its true costs before budget discussions. Cover all direct and indirect expenses, leverage historical data, plan for future costs, and ensure favorable payment terms to protect your financial interests.

The benefits of diversity and inclusion in clinical research are widely recognized, yet the financial and operational costs of these efforts are often overlooked. Practical strategies are needed to identify and mitigate these hidden costs, helping organizations create effective and sustainable strategies. These will be more important than ever if current U.S. Food and Drug Administration draft guidance on diversity action plans eventually goes into effect.