Adults over 65 represent approximately 15% of the U.S. population but consume approximately 34% of all prescription medications. Yet for decades, clinical trials excluded or severely underenrolled older adults, citing concerns about comorbidities and polypharmacy. The result has been a medical literature with significant evidence gaps for the population it most frequently serves.
Why Older Adults Were Excluded
Historically, trial exclusion criteria included: – Age limits (e.g., “no participants over 65”) – Requirements for absence of comorbidities common in older adults (hypertension, diabetes, kidney disease) – Restrictions on concomitant medications, which most older adults take
These restrictions simplified trial execution but produced drugs approved based on evidence from younger, healthier populations.
What Has Changed
FDA guidance now actively encourages enrollment of older adults in clinical trials. Guidelines recommend that trials reflect the population who will actually use the drug, which, for most conditions, includes many adults over 65.
Eligibility Considerations for Older Adults
Age itself, pure age limits are now discouraged by regulators and are less common in modern protocols.
Kidney function, many trials set eGFR thresholds because kidney function affects drug metabolism. Older adults with lower eGFR may be excluded from some studies.
Polypharmacy, drug-drug interaction exclusions may affect older adults on multiple medications. A study coordinator can review your medication list.
Cognitive consent, formal capacity to provide informed consent is required.
Benefits of Trial Participation for Older Adults
- Free medical evaluations, blood tests, and close monitoring
- Access to investigational treatments
- Close physician oversight throughout the study
- Contribution to research that will benefit older adults specifically
Contact NuLine to ask whether you may be eligible for a current study.