Clinical Trial Diversity
Problem: Young adult patients are a growing demographic, with over half of young adults in the United States living with a chronic condition. Yet, clinical care has often treated young adults (>18) similarly to their older counterparts. In addition, young adults are known to be underrepresented in clinical trials. This is significant because there are a great deal of physiological changes that occur between the ages of 18 and 39, which can affect disease processes and presentation, the response to treatments, and potential complications. Young adults may experience different drug dispositions and adverse events for certain diseases, highlighting the urgent need to investigate this population differently than pediatrics, adults or older adults.
The lack of focus on age extends to adverse event reporting systems. The Food and Drug Administration (FDA) groups ages 18-64 as one demographic in their adverse event reporting, while the Centers for Disease Control (CDC) has narrower subgroups, such as ages18-29, in their adverse event reports. The Surveillance, Epidemiology, and End Results (SEERS) and the National Childhood Cancer Registry (NCCR) subgroups by five years, pointing to the differences in childhood, adolescent, and young adult cancers.
Solution: It is critical to disaggregate data for young adults, beginning with sponsors making this data more readily available and the FDA mandating data disaggregated public reporting through its diversity efforts. Furthermore, conditions affecting young adults should be investigated for potentially differing disease epidemiology and trial data should be available for disaggregation by at least five years.