Older Adults in Clinical Research and Drug Development: Closing the Geriatric Gap.

" For age is opportunity no less Than youth itself, though in another dress, And as the evening twilight fades away The sky is filled with stars, invisible by day. " A s cardiovascular specialists, we are caring for a rapidly growing number of older adults despite limited data to guide therapeutics in this population. During the next 25 years, the population age ≥85 years will be more than double—from 6.3 million in 2015 to 14.1 million by 2040. 1 Over 25 years ago, the Food and Drug Administration (FDA) published the Guideline for the Study of Drugs Likely to be Used in the Elderly advocating that the population studied should reflect the population treated. 2 A 2011 review by Cherubini et al 3 demonstrated that 25% of heart failure trials had an arbitrary upper age exclusion; in the same year Zulman et al 4 demonstrated that 45.6% of trials had other criteria that disproportionately excluded older adults (eg, decreased life expectancy, functional limitations, cognitive impairment, serious concomitant illness, or nursing home residence). Furthermore, many trials under-represent women, who comprise the majority of older cohorts. Thus, it is no surprise that Medicare beneficiaries, almost all of whom have multiple chronic conditions, differ significantly from participants in trials used to inform Medicare coverage decisions. 5 The application of data and treatment recommendations from studied to unstudied populations can result in catastrophic consequences and increased costs. The medical community has suggested elimination of age-based exclusions, justification for exclusion criteria that limit inclusion of older individuals, performance of trials specific to older individuals, and reporting trends to assess inclusion of older adults in clinical trials. 6 However, as a medical community, we have yet to embark on the kind of systematic effort necessary to ensure representation of older adults in pivotal research. There has also been slow bureaucratic progress. In 2012, the FDA published the ICH-E7 Studies in Support of Special Populations: Geriatrics Guidance for Industry, which presented nonbinding recommendations to improve representation of older adults in trials. 7 This document reiterated the importance of including older adults in research, encouraged early discussions with FDA, and outlined similar suggestions to those made previously. 6 In 2014, the FDA prepared an action plan to Section 907 of the Food and Drug Administration Safety and Innovation Act (Pub L. 112–144) in which Congress directed them to report safety and effectiveness by sex, age, race, and …