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Suggested Citation:"1 INTRODUCTION." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
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Page 1
Suggested Citation:"1 INTRODUCTION." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
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Page 2
Suggested Citation:"1 INTRODUCTION." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
×
Page 3
Suggested Citation:"1 INTRODUCTION." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
×
Page 4

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

1 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 80 years and over (Milton et al., 2008; Rankin et al., 2018). 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 over age 65. 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 aged 65 to 75 years versus those 85 years and older). The workshop was sponsored by three forums of the National Academies: the Forum on Aging, Disability, and Independence; the 1 This workshop was organized by an independent planning committee whose role was limited to identification of topics and speakers. This Proceedings of a Workshop was prepared by the rapporteurs as a factual summary of the presentations and discussion that took place at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants and are not 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. PREPUBLICATION COPY: UNCORRECTED PROOFS 1-1

1-2 DRUG R&D FOR ADULTS ACROSS THE OLDER AGE SPAN 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.4 BOX 1-1 Statement of Task This virtual public workshop will provide a venue for stakeholders to discuss 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 the clinical pharmacology for 65+ and 80+ populations. The workshop will feature invited presentations and discussions to: Review the current landscape of drug R&D for 65+ and 80+ populations across public and private sectors: • Consider medication issues for older adult populations (e.g., dosage forms, adherence, polypharmacy, differences in pharmacokinetics/pharmacodynamics); • Explore methodologies that are currently used or could be implemented to study differences in pharmacology for older adult populations (e.g., minimal sampling); • Examine barriers to conducting clinical research for 65+ and 80+ populations (e.g., funding, data, comorbidity, polypharmacy, recruitment, access); and • Explore approaches to engage 65+ and 80+ populations in clinical research and strategies to generate evidence-based information on how to best optimize treatment for older adults. A planning committee will organize the workshop, develop the agenda, select and invite speakers and discussants, and moderate or identify moderators for the discussions. A proceedings of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines. 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,5 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 research and development for older adults. The second session examined challenges to including this population in research, including 4 The planning committee’s role was limited to planning the workshop, and the 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. 5 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); Inclusion Across the Lifespan workshop (NIH, 2018). PREPUBLICATION COPY: UNCORRECTED PROOFS

1-2 DRUG R&D FOR ADULTS ACROSS THE OLDER AGE SPAN 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. PREPUBLICATION COPY: UNCORRECTED PROOFS

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There is a void in evidence-based information for making informed decisions on how to optimize care for older adults, particularly those 80 years and over. Because older adults are vastly underrepresented in clinical trials, there is a dearth of information about the appropriate use of drugs in this population. Yet older adults have higher rates of comorbidities and simultaneous use of multiple medications than the general population, 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.

On August 5 and 6, 2020, the National Academies of Sciences, Engineering, and Medicine hosted a 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 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 over age 65. This publication summarizes the presentation and discussion of the workshop.

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