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Introduction1
Despite the widespread recognition of the “graying of America” (Vespa, 2018) and the need for health care among older adults, there is a dearth of information about the appropriate use of drugs in this population. Older adults are vastly underrepresented in clinical trials (Herrera et al., 2010). Yet, older adults have higher rates of comorbidities and polypharmacy (the simultaneous use of multiple medications by an individual) than the general population (Nobili et al., 2011), and are the majority users of many medications. Additionally, age-related physiological and pathological changes, particularly for adults 80 years of age and older, can lead to significant differences in the pharmacokinetics (PK)2 and pharmacodynamics (PD)3 of a given drug compared to the general population (Fialová et al., 2018). There is a void in evidence-based information for making informed decisions on how to optimize care for older adults, particularly those age 80 and over (Milton et al., 2008; Rankin et al., 2018).
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1 The planning committee’s role was limited to planning the workshop, and this Proceedings of a Workshop was prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants and are not necessarily endorsed or verified by the National Academies of Sciences, Engineering, and Medicine, and they should not be construed as reflecting any group consensus.
2 The main processes involved in pharmacokinetics are drug absorption, distribution, metabolism, and excretion.
3 Pharmacodynamics is the study of the biochemical and physiologic effects of drugs.
On August 5 and 6, 2020, the National Academies of Sciences, Engineering, and Medicine (the National Academies) hosted a virtual workshop titled Drug Research and Development for Adults Across the Older Age Span. The workshop was designed to examine the challenges and opportunities in drug research and development (R&D) for older adult populations, explore barriers that impede safety and efficacy studies in these populations, and share lessons learned for better understanding clinical pharmacology for populations 65 and older. The title of the workshop was deliberately worded, said James Appleby, chief executive officer of The Gerontological Society of America and chair of the workshop. “Across the Older Age Span” is meant to emphasize the fact that older adults are not a homogeneous group and that challenges to research and care may vary depending on the group of interest (e.g., individuals age 65 to 75 years versus those age 85 and older). The workshop was sponsored by three forums of the National Academies: the Forum on Aging, Disability, and Independence; the Forum on Drug Discovery, Development, and Translation; and the National Cancer Policy Forum. The workshop planning committee followed a Statement of Task (see Box 1-1) to develop the workshop agenda and to identify speakers.
This workshop, said Appleby, was envisioned long before the coronavirus disease 2019 (COVID-19) pandemic “turned our world upside down.” However, the vastly disproportionate impact that COVID-19 has had on older adults, particularly those with underlying conditions, is a stark reminder of the need to improve drug R&D for this population. Although the workshop builds on prior work,4 he continued, it also breaks new ground by addressing R&D for older adults in the era of COVID-19. The workshop was divided into three sessions. First, speakers and participants discussed the current landscape of R&D for older adults. The second session examined challenges to including this population in research, including medication adherence, comorbidities, and polypharmacy; it also looked at innovative approaches for studying pharmacology in older adults. The third session was divided into three parts: (1) approaches for engaging older adults in clinical trials; (2) lessons learned from the COVID-19 pandemic and its impact on older adults and clinical trial research; and (3) the future of older adults and clinical trial research.
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4 Workshop on Drug Development for the Geriatric Populations (NRC, 1990); Workshop on Pharmacokinetics and Drug Interactions in the Elderly and Special Issues in Elderly African American Populations (IOM, 1997); and Inclusion Across the Lifespan workshop (NIH, 2018).
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