Trials for Type 2 diabetes, stroke prevention and heart failure drug candidates have consistently underrepresented study participants older than 80 years old, according to FDA researchers.
In a study published Oct. 14 in JAMA, researchers examined 166 clinical trials tied to applications for new drugs and biologics submitted between 2010 and 2019. During that time, people 75 and older were underrepresented for Type 2 diabetes and non-small cell lung cancer. And trials for nonvalvular atrial fibrillation stroke prevention, insomnia, heart failure and osteoporosis failed to include enough participants who were 80 and older.
This inconsistency in age group representation for new drug applications could hide the overall efficacy of these drugs because "older adults may represent significant proportions of the treatment population," the researchers concluded.
Trial enrollment efforts for older populations may be hindered by polypharmacy, multimorbidity and organ dysfunction, but the study's authors said closing the gap requires regulatory action.