karen-alexanderThe year was 1989, and the FDA publication was “Guideline for the Study of Drugs Likely to be Used in the Elderly.” Fast forward to the present, where 25% of heart failure trials still have an upper age exclusion and 45% of trials have other criteria that disproportionately excludes older adults. In 2014, Congress directed the FDA to prepare an action plan to Section 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub L. 112-144) which requires safety and effectiveness to be reported by sex, age, race, and ethnicity. The resulting FDA Snapshots added transparency on age group inclusion but did nothing to increase representation of older adults. Instead of continuing to characterize this geriatric gap for the next 25 years, we need to design and implement mandates, partnerships and incentives to ensure representation of older adults in evidence which forms the basis of their care. The systematic path forward has been paved by other populations with examples of actionable approaches below:

  • Age can be added to Targeted/planned enrollment tables for inclusion of older adults (age ≥75), just like already required for gender/race/ethnicity in NIH trials.
  • An Office of Geriatric Health and Aging can be established within the FDA, just like existing offices for other special populations, Office of Women’s Health, Office of Minority Health, and Office of Pediatric Therapeutics. This office would review early studies for dosing alterations with age, enrollment and data collection plans, and inclusion of older adults in trials relevant to care of older adults.
  • A Geriatric Exclusivity Rule could be passed to grant patent extension for collecting adequate information in older populations, just like the Pediatric Exclusivity Rule (1997) which provides drug manufacturers a 6-month patent extension for conducting studies in children. While requiring an act of Congress, it would protect our elders as we similarly protect our youth. Both have age-associated alterations in physiology hence pharmacokinetics and pharmacodynamics.
  • A Geriatric Value Category could be added to the package insert to provide a uniform risk/benefit rating, just like the Pregnancy Rating Category on labels indicates strength of evidence for safety during pregnancy.
  • Engage Older Adults. Many older adults are eager to connect and contribute to future generations, but need time, education and encouragement to understand participation in clinical trials. Simplified consent forms with large type, added time to consult with family, use of proxy data or remote follow up, and other ideas can be elicited to overcome barriers to participation. Participants in clinical trials have better care and outcomes.
  • Engage Payers. Payers, and specifically Medicare, could provide education about the importance of research participation in subscriber welcome packets, creating a special identifier for those willing to be contacted for participation. Similarly, payers should partner with drug and device manufacturers to identify research priorities for older populations and collaborate in research designs. Those drugs or devices with best evidence in older adults (see Geriatric Value Category above) could get market advantage by payers, a value passed on to older adults with safer care at lower costs.


By: Karen Alexander, MD



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