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Suggested Citation:"Front Matter." 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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Drug Research and Development for Adults Across the Older Age Span

PROCEEDINGS OF A WORKSHOP

Erin Hammers Forstag and Carolyn Shore, Rapporteurs

Forum on Aging, Disability, and Independence

Forum on Drug Discovery, Development, and Translation

National Cancer Policy Forum

Board on Health Care Services

Board on Health Sciences Policy

Health and Medicine Division

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Suggested Citation:"Front Matter." 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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This activity was supported by contracts between the National Academy of Sciences and the Administration for Community Living; American Association for Cancer Research; American Association for Retired Persons; American Cancer Society (Contract No. 66383); American College of Radiology; American Geriatrics Society; American Society of Clinical Oncology; Amgen Inc. (Contract No. GHCCOPS-CSARF-175837); Association of American Cancer Institutes; Association of American Medical Colleges; Association of Community Cancer Centers; AstraZeneca; Biogen; Biomedical Advanced Research and Development Authority; Bristol Myers Squibb (Contract No. 57015377); Burroughs Wellcome Fund (Contract No. 1020264); Cancer Support Community; Centers for Disease Control and Prevention (Contract No. 200-2011-38807; Task Order No. 75D30119F00080); CEO Roundtable on Cancer; Consumer Technology Association Foundation; Critical Path Institute; Eli Lilly and Company (Contract No. 4900709231); FasterCures, Milken Institute; Flatiron Health; Foundation for the National Institutes of Health; Friends of Cancer Research; The Gerontological Society of America; GlaxoSmithKline (Contract No. OTH-PPL-32245); The John A. Hartford Foundation; Johnson & Johnson; LeadingAge; Merck & Co., Inc. (Contract Nos. MRLCPO-19-9858 and MRLCPO-19-106723); National Comprehensive Cancer Network; National Institute on Disability, Independent Living, and Rehabilitation Research (Contract No. HHSP233201400020B); National Institutes of Health (Contract No. HHSN263201800029I; Task Order No. HHSN26300007): National Cancer Institute, National Center for Advancing Translational Sciences, National Institute of Allergy and Infectious Diseases, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, Office of Extramural Research, Office of Science Policy; National Institutes of Health (Contract No. HHSN263201800029I; Task Order No. HHSN26300008 and Contract No. HHSN263291800029I; Task Order No. 75N98019F00848): National Institute on Aging; National Patient Advocate Foundation; New England Journal of Medicine; Novartis Oncology (Contract No. NGC38403); Oncology Nursing Society; Paraprofessional Healthcare Institute; Pfizer Inc.; Sanofi (Contract No. 57505685); Society for Immunotherapy of Cancer; Takeda Pharmaceuticals (Contract No. 53108); and U.S. Food and Drug Administration (Grant No. 5R13FD005496-05). Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

International Standard Book Number-13: 978-0-309-68568-9
International Standard Book Number-10: 0-309-68568-0
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Suggested citation: 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. https://doi.org/10.17226/25998.

Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task.

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Suggested Citation:"Front Matter." 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.
×

PLANNING COMMITTEE FOR A WORKSHOP ON DRUG RESEARCH AND DEVELOPMENT FOR ADULTS ACROSS THE OLDER AGE SPAN1

JAMES APPLEBY (Chair), The Gerontological Society of America

MARIE A. BERNARD, National Institute on Aging, National Institutes of Health

BARRY S. COLLER, The Rockefeller University

DEBORAH COLLYAR, Patient Advocates in Research

DONALD HARVEY, Emory University School of Medicine

ALEX JOHN LONDON, Carnegie Mellon University

DAVID REUBEN, University of California, Los Angeles

MARK ROGGE, Takeda Pharmaceuticals

JANICE B. SCHWARTZ, University of California, San Francisco

MIRIAM MOBLEY SMITH, Northeastern University Bouvé College of Health Sciences School of Pharmacy

ROBERT TEMPLE, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

JONATHAN WATANABE, University of California, Irvine, School of Pharmacy and Pharmaceutical Sciences

BARBARA ZAROWITZ, University of Maryland School of Pharmacy

Health and Medicine Division Staff

CAROLYN K. SHORE, Director, Forum on Drug Discovery, Development, and Translation

LORI BRENIG, Research Associate (from May 2020)

AMANDA WAGNER GEE, Program Officer

JENNIFER HINNERS, Program Officer (through October 2020)

EESHAN KHANDEKAR, Associate Program Officer (through October 2020)

MELVIN JOPPY, Senior Program Assistant

ANDREW M. POPE, Senior Director, Board on Health Sciences Policy

Consultant

ERIN HAMMERS FORSTAG, Science Writer

___________________

1 The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." 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.
×

FORUM ON AGING, DISABILITY, AND INDEPENDENCE1

STEPHEN EWELL (Co-Chair), Consumer Technology Association Foundation

REBECCA JACKSON STOECKLE (Co-Chair), Education Development Center

JOHN AUERBACH, Trust for America’s Health

MARIE A. BERNARD, National Institute on Aging, National Institutes of Health

JULIE BYNUM, University of Michigan Medical School

MARGARET L. CAMPBELL, Campbell & Associates Consulting

BRUCE CHERNOF, The SCAN Foundation

TAMALA DAVID, State University of New York College at Brockport

THOMAS E. EDES, U.S. Department of Veterans Affairs

ROBERT ESPINOZA, Paraprofessional Healthcare Institute

DONNA FICK, The Pennsylvania State University College of Nursing

TERRY T. FULMER, The John A. Hartford Foundation

KATHY GREENLEE, Greenlee Global LLC

ROBERT JARRIN, The Omega Concern LLC

SUSAN JENKINS, Administration for Community Living

JANNI LEHRER-STEIN, Disability Policy Consultant and Advocate

SARAH RUIZ, National Institute on Disability, Independent Living, and Rehabilitation Research

KATIE SMITH SLOAN, LeadingAge

ERWIN TAN, AARP

FERNANDO TORRES-GIL, University of California, Los Angeles

Forum Staff

TRACY A. LUSTIG, Forum Director

SIOBHAN ADDIE, Program Officer

RUKSHANA GUPTA, Senior Program Assistant

SHARYL NASS, Senior Director, Board on Health Care Services

___________________

1 The National Academies of Sciences, Engineering, and Medicine’s forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." 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.
×

FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION1

ROBERT M. CALIFF (Co-Chair), Duke University and Verily Life Sciences

GREGORY SIMON (Co-Chair), Kaiser Permanente Washington Health Research Institute and University of Washington

AMY ABERNETHY, Office of the Commissioner, U.S. Food and Drug Administration

CHRISTOPHER P. AUSTIN, National Center for Advancing Translational Sciences

LINDA BRADY, National Institute of Mental Health, National Institutes of Health

BARRY S. COLLER, The Rockefeller University

THOMAS CURRAN, Children’s Mercy, Kansas City

RICHARD DAVEY, National Institute of Allergy and Infectious Diseases, National Institutes of Health

KATHERINE DAWSON, Biogen

JAMES H. DOROSHOW, National Cancer Institute, National Institutes of Health

JEFFREY M. DRAZEN, New England Journal of Medicine

STEVEN K. GALSON, Amgen Inc.

CARLOS O. GARNER, Eli Lilly and Company

JULIE L. GERBERDING, Merck & Co., Inc.

ANNE HEATHERTON, Takeda Pharmaceuticals

DEBORAH HUNG, Harvard Medical School

ESTHER KROFAH, FasterCures, Milken Institute

LISA M. LaVANGE, University of North Carolina

ROSS McKINNEY, JR., Association of American Medical Colleges

JOSEPH P. MENETSKI, Foundation for the National Institutes of Health

ARTI RAI, Duke University School of Law

KELLY ROSE, Burroughs Wellcome Fund

SUSAN SCHAEFFER, Patients’ Academy for Research Advocacy

JOSEPH SCHEEREN, Critical Path Institute

ANANTHA SHEKHAR, University of Pittsburgh

JAY SIEGEL, Retired

ELLEN V. SIGAL, Friends of Cancer Research

LANA R. SKIRBOLL, Sanofi

___________________

1 The National Academies of Sciences, Engineering, and Medicine’s forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Page viii Cite
Suggested Citation:"Front Matter." 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.
×

AMIR TAMIZ, National Institute of Neurological Disorders and Stroke, National Institutes of Health

ANN TAYLOR, AstraZeneca

PAMELA TENAERTS, Clinical Trials Transformation Initiative, Duke University

JOANNE WALDSTREICHER, Johnson & Johnson

ROBERT WALKER, Biomedical Advanced Research and Development Authority

JONATHAN WATANABE, University of California, Irvine, School of Pharmacy and Pharmaceutical Sciences

CARRIE WOLINETZ, Office of Science Policy, National Institutes of Health

ALASTAIR WOOD, Vanderbilt University

JANET WOODCOCK, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Forum Staff

CAROLYN K. SHORE, Forum Director

JENNIFER HINNERS, Program Officer (through October 2020)

AMANDA WAGNER GEE, Program Officer

EESHAN KHANDEKAR, Associate Program Officer (through October 2020)

MELVIN JOPPY, Senior Program Assistant

ANDREW M. POPE, Senior Director, Board on Health Sciences Policy

Suggested Citation:"Front Matter." 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.
×

NATIONAL CANCER POLICY FORUM1

EDWARD J. BENZ, JR. (Chair), Dana-Farber Cancer Institute and Harvard Medical School

PETER C. ADAMSON, Sanofi

GARNET L. ANDERSON, Fred Hutchinson Cancer Research Center and University of Washington

KAREN BASEN-ENGQUIST, University of Texas MD Anderson Cancer Center

SMITA BHATIA, The University of Alabama at Birmingham

LINDA BOHANNON, Cancer Support Community

CHRIS BOSHOFF, Pfizer Inc.

CATHY J. BRADLEY, Colorado School of Public Health and University of Colorado Cancer Center

OTIS W. BRAWLEY, Johns Hopkins University

CYNTHIA BROGDON, Bristol Myers Squibb

WILLIAM G. CANCE, American Cancer Society

ROBERT W. CARLSON, National Comprehensive Cancer Network

GWEN DARIEN, National Patient Advocate Foundation

NANCY E. DAVIDSON, Seattle Cancer Care Alliance; Fred Hutchinson Cancer Research Center; and University of Washington

GEORGE D. DEMETRI, Harvard Medical School; Dana-Farber Cancer Institute; and Dana-Farber/Harvard Cancer Center

JAMES H. DOROSHOW, National Cancer Institute

NICOLE F. DOWLING, Centers for Disease Control and Prevention

SCOT W. EBBINGHAUS, Merck Research Laboratories

KOJO S. J. ELENITOBA-JOHNSON, University of Pennsylvania Perelman School of Medicine

STANTON L. GERSON, Case Western Reserve University and University Hospitals Seidman Cancer Center

HEDVIG HRICAK, Memorial Sloan Kettering Cancer Center

MIMI HUIZINGA, Novartis Oncology

ROY A. JENSEN, Association of American Cancer Institutes; The University of Kansas Cancer Center; and Kansas Masonic Cancer Research Institute

RANDY A. JONES, University of Virginia School of Nursing

BETH Y. KARLAN, University of California, Los Angeles

LISA KENNEDY SHELDON, Oncology Nursing Society

___________________

1 The National Academies of Sciences, Engineering, and Medicine’s forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." 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.
×

SAMIR N. KHLEIF, Georgetown University Medical Center/Society for Immunotherapy of Cancer

KAREN E. KNUDSEN, Sidney Kimmel Cancer Center

MIA LEVY, Rush University Cancer Center and Rush System for Health

NEAL J. MEROPOL, Flatiron Health

MARTIN J. MURPHY, CEO Roundtable on Cancer

RANDALL A. OYER, Penn Medicine Lancaster General Health

CLEO A. SAMUEL-RYALS, University of North Carolina at Chapel Hill

RICHARD L. SCHILSKY, American Society of Clinical Oncology

JULIE SCHNEIDER, U.S. Food and Drug Administration

LAWRENCE N. SHULMAN, University of Pennsylvania

LARA STRAWBRIDGE, Centers for Medicare & Medicaid Services

GEORGE J. WEINER, The University of Iowa

ROBERT A. WINN, Virginia Commonwealth University Massey Cancer Center

Forum Staff

ERIN BALOGH, Senior Program Officer

LORI BRENIG, Research Associate (from May 2020)

ANNALEE GONZALES, Administrative Assistant

SHARYL NASS, Director, National Cancer Policy Forum, and Senior Director, Board on Health Care Services

Suggested Citation:"Front Matter." 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.
×

Reviewers

This Proceedings of a Workshop was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process.

We thank the following individuals for their review of this proceedings:

CONSTANCE CITRO, The National Academies of Sciences, Engineering, and Medicine

PATRICIA JONES, National Institute on Aging, National Institutes of Health

JONATHAN WATANABE, University of California, Irvine

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the proceedings nor did they see the final draft before its release. The review of this proceedings was overseen by LESLIE BENET, University of California, San Francisco. He was responsible for making certain that an independent examination of this proceedings was carried out in accordance with standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies.

Suggested Citation:"Front Matter." 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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Acknowledgments

Support from the sponsors of the National Academies’ Forum on Aging, Disability, and Independence; Forum on Drug Discovery, Development, and Translation; and National Cancer Policy Forum is crucial to support this and other work of the National Academies.

The National Academies staff wish to express their gratitude to the speakers whose presentations helped inform workshop discussions on the state of drug research and development for adults across the older age span; the members of the planning committee for their work in developing the workshop agenda and shaping the discussions; Harpreet Singh for her valuable contributions; and National Academies staff without whom this workshop and the accounting thereof would not have been possible: Christie Bell, Robert Day, Sadaf Faraz, Andrew Grafton, Devona Overton, Bettina Seliber, Lauren Shern, Victor Stewart, and Taryn Young.

Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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Acronyms and Abbreviations

ASPREE Aspirin in Reducing Events in the Elderly
 
BiTE Bispecific T-Cell Engager
 
CDER Center for Drug Evaluation and Research
CDN Clinical Directors Network
CHW community health worker
CMS Centers for Medicare & Medicaid Services
COVID-19 coronavirus disease 2019
 
eHealth electronic health
EHR electronic health record
EMR electronic medical record
 
FDA U.S. Food and Drug Administration
FQHC federally qualified health center
 
GI gastrointestinal
 
IAL Inclusion Across the Lifespan
ICECAP Influence of Cooling duration on Efficacy in Cardiac Arrest Patients
IRB Institutional Review Board
Suggested Citation:"Front Matter." 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.
×
LABBPS Los Angeles Barbershop Blood Pressure Study
 
mHealth mobile health
MRI magnetic resonance imaging
 
NIA National Institute on Aging
NIH National Institutes of Health
 
PACE Programs for All-inclusive Care for the Elderly
PBRN Practice-Based Research Network
PCORI Patient-Centered Outcomes Research Institute
PD pharmacodynamics
PK pharmacokinetics
PRO patient-reported outcome
PTZ Piperacillin/Tazobactam
 
QSP Quantitative Systems Pharmacology
 
R&D research and development
RCT randomized controlled trial
REMAP randomized, embedded, multifactorial adaptive platform
 
TAVR transcatheter aortic valve replacement
 
USC University of Southern California
Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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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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