Time for Action: Including Older Adults in Clinical Trials

dodson%20headshotWe recently published an editorial in the Journal of the American Geriatrics Society entitled “Time for a New Approach to Studying Older People with Ischemic Heart Disease”. This was in response to a research article by Bourgeois et al. demonstrating that of medication trials for patients with ischemic heart disease published between 2006 and 2016, over half (53%) excluded older adults. The authors’ findings underscore the continued problem of under-representation of older adults in the most rigorously conducted research studies, which makes translating these studies’ results into practice especially challenging.

This is a longstanding problem that was highlighted by the FDA over 25 years ago. In our editorial, we highlighted several potential next steps to address this issue:

  1. Design clinical research studies with no upper age limit. Alternatively, mandate an explicit lower age limit for inclusion – for example, only enroll patients age ≥75. Since there are fundamental phenotypic differences in older patients (including aging-related impairments such as frailty, sarcopenia, visual/sensory impairments, and cognitive impairment), this approach would ensure these characteristics are adequately represented.
  2. Create an Office of Geriatric Health and Aging within FDA, which would provide expertise for review of protocols on dosing, enrollment, and data collection in older patients.
  3. Add an exclusivity rule to extend patent life in drugs with proven safety and efficacy specifically in older adults, which would incentivize drug manufacturers to focus on aging. This approach has been previously described by Skolnick and Alexander.

These are just few examples of concrete steps that can be taken to address a problem that has long been recognized. With our aging population, and in light of current clinical uncertainties in cardiovascular medicine, there is a critical need for action.

 

By: John Dodson, MD

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