This virtual public workshop provided a venue for stakeholders to discuss the challenges and opportunities in drug research and development for older adult populations, explored barriers that impede safety and efficacy studies in these populations, and shared lessons learned for better understanding the clinical pharmacology for 65+ and 80+ populations. The workshop was convened under the auspices of the National Academies Forum on Drug Discovery, Development, and Translation; the Forum on Aging, Disability, and Independence, and the National Cancer Policy Forum.
Background
Despite the widespread recognition of the “graying of America,” 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. Yet older adults have higher rates of comorbidities and polypharmacy than the general population, and are the majority users of many medications. Additionally, age-related physiological and pathological changes, particularly for adults 80+, can lead to significant differences in the pharmacokinetic and pharmacodynamics of a given drug compared to the general population. There is a void in evidence-based information for making informed decisions on how to best optimize care for older adults, particularly those 80+.
The National Academies of Sciences, Engineering, and Medicine held a virtual public workshop, Drug Research and Development for Adults Across the Older Age Span, on August 5-6, 2020. The workshop provided a venue for stakeholders to discuss the challenges and opportunities in drug research and development (R&D) for older adult populations, explored barriers that impede safety and efficacy studies in these populations, and shared lessons learned for better understanding the clinical pharmacology for 65+ and 80+ populations.
The workshop featured 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 PK/PD);
- 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, co-morbidity, polypharmacy, recruitment, access); and
- Explore approaches to engage 65+ and 80+ populations in clinical research and strategies generate evidence-based information on how to best optimize treatment for older adults.
The workshop was accessible to the public via live webcast.
Planning Committee
James Appleby (Chair), The Gerontological Society of America
Marie A. Bernard, National Institute on Aging, NIH
Barry S. Coller, The Rockefeller University
Deborah Collyar, Patient Advocates in Research
Donald Harvey, Emory University School of Medicine
Alex John London, Cernegie Mellon University
David Reuben, University of California, Los Angeles
Mark Rogge, Takeda Pharmaceutical
Janice B. Schwartz, University of California, San Francisco
Miriam Mobley Smith, Northeastern University
Robert Temple, Center for Drug Evaluation and Research, U.S. FDA
Jonathan Watanabe, University of California Irvine Samueli College of Health Sciences
Barbara Zarowitz, University of Maryland School of Pharmacy