In January 2019, the National Institutes of Health (NIH), responding to many years of advocacy, expanded their inclusivity requirements for clinical trials to include representation of older adults.1 What is the current state of inclusion of older adults in cardiovascular trials? The answer is distressing.
Nanna et al2 examine cardiovascular trials that commenced enrollment in the 12 months before and after the inception of the NIH Inclusion Across the Lifespan Policy. Of 97 cardiovascular trials identified, only 5 were NIH funded, whereas a majority were industry or institutionally sponsored. Privately funded studies are not required to adhere to the NIH policy, and unsurprisingly, Nanna et al found no significant change in inclusivity practices across the total study group before and after the NIH policy went into effect. Although explicit upper age limits were uncommon, more than 70% of trials excluded participants on the basis of characteristics such as functional status, cognitive impairment, or decreased life expectancy. Meanwhile, outcomes relevant to geriatric populations—such as measures of function, mobility, or quality of life—were usually lacking.