Young adults with chronic medical conditions represent a distinct and growing demographic, with over half of young adults in the United States managing at least one chronic condition. Despite this, clinical trials often overlook the unique needs and characteristics of young adults (>18 years of age), leading to significant gaps in our understanding of how treatments affect this population.

Current clinical trials often group a wide range of ages (e.g., 18-64) when reporting safety and efficacy data. This broad categorization can obscure age-specific responses to treatments. Establishing clearer age brackets in clinical trial design and data reporting is crucial for identifying potential risks or dispositions unique to young adults.

Check out our latest work:
  • Comment to FDA - Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies; Guidance for Industry
  • Abstract at UEGW - United European Gastroenterology Week: Exploring the age spectrum of real-world patients with Inflammatory Bowel Disease: a machine learning approach
  • STAT News Article: If Pharma Can Market to Youths by TikTok, it Should Include Them in Clinical Trials
  • Generation Patient Letter: Prescription Drug User Fee Act Feedback
  • Presentation at University of Pennsylvania’s Research Ethics and Policy Series (REPS): Representation of Adolescents and Young Adults in Clinical Trials

There are biological impacts of age, including: 

  • Young adults experience unique physiological changes, including hormonal shifts, rapid metabolic adaptations, and varying immune responses, which may affect how they react to medications compared to older adults. 

  • For example, hormonal fluctuations can influence drug metabolism, potentially altering therapeutic effects or risk profiles. 

To better understand age-related differences, we recommend public data disaggregation: 

  • Sponsors make age-specific data more accessible.

  • The FDA mandates public reporting of disaggregated data by age.

  • At least five-year increments disaggregate trial data.

Recent research proposes a standardized set of age groupings for health data, including more nuanced groupings for younger ages followed by 5-year age groupings for adults (see sources here and here).

Improving Adverse Event Reporting

The lack of focus on age-specific data extends to adverse event reporting systems. Currently, the FDA groups individuals aged 18-64 as a single demographic. Disaggregating data by narrower age brackets is crucial for publicly capturing the nuances of disease epidemiology and treatment effects in young adults.

In 2025, we will continue developing evidence and working with legislators to determine the next steps for more representative and transparent clinical trials. For more information or to collaborate, email admin@generationpatient.org.