Innovation in
Cancer Care and Cancer Research
in the Context of the
COVID-19 Pandemic
PROCEEDINGS OF A WORKSHOP
Francis Amankwah, Erin Balogh, Anne Frances Johnson, and
Sharyl Nass, Rapporteurs
National Cancer Policy Forum
Board on Health Care Services
Health and Medicine Division
THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu
THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001
This activity was supported by Contract No. 200-2011-38807 (Task Order No. 75D30120F00089) and Contract No. HHSN263201800029I (Task Order No. HHSN26300008) with the Centers for Disease Control and Prevention and the National Cancer Institute/National Institutes of Health, respectively, and by the American Association for Cancer Research, American Cancer Society, American College of Radiology, American Society of Clinical Oncology, Association of American Cancer Institutes, Association of Community Cancer Centers, Bristol Myers Squibb, Cancer Support Community, CEO Roundtable on Cancer, Flatiron Health, Merck, National Comprehensive Cancer Network, National Patient Advocate Foundation, Novartis Oncology, Oncology Nursing Society, Pfizer Inc., Sanofi, and Society for Immunotherapy of Cancer. 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: 978-0-309-27762-4
International Standard Book Number-10: 0-309-27762-0
Digital Object Identifier: https://doi.org/10.17226/26470
Additional copies of this publication are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu.
Copyright 2022 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2022. Innovation in cancer care and cancer research in the context of the COVID-19 pandemic: Proceedings of a workshop. Washington, DC: The National Academies Press. https://doi.org/10.17226/26470.
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WORKSHOP PLANNING COMMITTEE1
RICHARD L. SCHILSKY (Chair), Principal Investigator, American Society of Clinical Oncology Targeted Agent and Profiling Utilization Registry Study; and Professor Emeritus, University of Chicago
SUNDEEP AGRAWAL, Acting Team Lead, Genitourinary Malignancies, Center for Drug Evaluation and Research, Division of Oncology; and Clinical Lead, Project Renewal, Oncology Center of Excellence, Food and Drug Administration
CHRISTINA CHAPMAN, Assistant Professor of Radiation Oncology, University of Michigan
NANCY E. DAVIDSON, President and Executive Director, Seattle Cancer Care Alliance; Raisbeck Endowed Chair for Collaborative Research, Senior Vice President, Director, and Professor, Clinical Research Division, Fred Hutchinson Cancer Center, and Head, Department of Medicine, Division of Medical Oncology, University of Washington
MELISSA DILLMON, Medical Oncology Specialist, Harbin Clinic
JAMES H. DOROSHOW, Director, Division of Cancer Treatment and Diagnosis; Deputy Director for Clinical and Translational Research; and Head, Oxidative Signaling and Molecular Therapeutics Group, National Cancer Institute
SAMIR N. KHLEIF, Director, Jeannie and Tony Loop ImmunoOncology Lab; Biomedical Scholar and Professor of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center; and Member, Society for Immunotherapy of Cancer
KAREN E. KNUDSEN, Chief Executive Officer, American Cancer Society, Inc., and American Cancer Society Cancer Action Network
MIA LEVY,2 The Sheba Foundation Director, Rush University Cancer Center; Associate Professor, Department of Internal Medicine, Division of Hematology, Oncology, and Cell Therapy, Rush University; and System Vice President, Cancer Services, Rush System for Health
___________________
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.
2 In August 2021, Mia Levy became Chief Medical Officer of Foundation Medicine.
LARISSA NEKHLYUDOV, Professor of Medicine, Harvard Medical School; Internist, Brigham and Women’s Hospital; and Clinical Director, Internal Medicine for Cancer Survivors, Dana-Farber Cancer Institute
RANDALL A. OYER, Medical Director, Oncology, Ann B. Barshinger Cancer Institute; Medical Director, Cancer Risk Evaluation Program Penn Medicine Lancaster General Health; and Past President, Association of Community Cancer Centers
ANTONI RIBAS, Professor of Medicine, Surgery, and Molecular and Medical Pharmacology; Director of the Tumor Immunology Program, Jonsson Comprehensive Cancer Center; and Director, Parker Institute for Cancer Immunotherapy Center, University of California, Los Angeles
DONNA R. RIVERA, Associate Director of Pharmacoepidemiology, Oncology Center of Excellence, Office of the Commissioner, Food and Drug Administration
LAWRENCE N. SHULMAN, Professor of Medicine, Deputy Director for Clinical Services, and Director, Center for Global Cancer Medicine, Abramson Cancer Center, University of Pennsylvania
ROBERT A. WINN, Director, Massey Cancer Center; Senior Associate Dean for Cancer Innovation; Professor, Pulmonary Disease and Critical Care Medicine; and Lipman Chair in Oncology, School of Medicine, Virginia Commonwealth University
Project Staff
FRANCIS AMANKWAH, Program Officer
RACHEL AUSTIN, Senior Program Assistant
LORI BENJAMIN BRENIG, Research Associate
ANNALEE GONZALES, Administrative Assistant
KAFAYAT MAHMOUD, Christine Mirzayan Science & Technology Policy Graduate Fellow (September–November 2021)
MICAH WINOGRAD, Senior Finance Business Partner
ERIN BALOGH, Co-Director, National Cancer Policy Forum
SHARYL NASS, Co-Director, National Cancer Policy Forum; and Senior Director, Board on Health Care Services
NATIONAL CANCER POLICY FORUM1
EDWARD J. BENZ, JR. (Chair), President and Chief Executive Officer Emeritus, Dana-Farber Cancer Institute; and Richard and Susan Smith Distinguished Professor of Medicine, Genetics and Pediatrics, Harvard Medical School
PETER C. ADAMSON, Global Head, Oncology Development and Pediatric Innovation, Sanofi
GARNET L. ANDERSON, Senior Vice President and Director, Public Health Sciences Division, Fred Hutchinson Cancer Center; Principal Investigator, Clinical Coordinating Center, Women’s Health Initiative; and Affiliate Professor, Department of Biostatistics, University of Washington
KAREN BASEN-ENGQUIST, Annie Laurie Howard Research Distinguished Professor, Professor of Behavioral Science, and Director, Center for Energy Balance in Cancer Prevention and Survivorship, The University of Texas MD Anderson Cancer Center
SMITA BHATIA, Professor and Vice Chair, Department of Pediatrics; Gay and Bew White Endowed Chair in Pediatric Oncology; Director, Institute for Cancer Outcomes and Survivorship; and Associate Director for Outcomes Research, Comprehensive Cancer Center, The University of Alabama at Birmingham
CHRIS BOSHOFF, Chief Development Officer, Oncology, Global Product Development, Pfizer Inc.
CATHY J. BRADLEY, David F. and Margaret Turley Grohne Chair for Cancer Prevention and Control Research; Professor and Associate Dean for Research, Colorado School of Public Health; and Deputy Director and Bunn Chair of Cancer Research, University of Colorado Comprehensive Cancer Center
OTIS W. BRAWLEY, Bloomberg Distinguished Professor, Department of Epidemiology, Bloomberg School of Public Health and Department of Oncology, School of Medicine, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University
CYNTHIA BROGDON, Head, U.S. Oncology Portfolio Strategy, Bristol-Myers Squibb
___________________
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.
WILLIAM G. CANCE, Chief Medical and Scientific Officer, American Cancer Society
ROBERT W. CARLSON, Chief Executive Officer, National Comprehensive Cancer Network
CHRISTINA CHAPMAN, Assistant Professor of Radiation Oncology, University of Michigan
GWEN DARIEN, Executive Vice President, Patient Advocacy and Engagement, National Patient Advocate Foundation
NANCY E. DAVIDSON, President and Executive Director, Seattle Cancer Care Alliance; Raisbeck Endowed Chair for Collaborative Research, Senior Vice President, Director, and Professor, Clinical Research Division, Fred Hutchinson Cancer Center; and Head, Department of Medicine, Division of Medical Oncology, University of Washington
JAMES H. DOROSHOW, Director, Division of Cancer Treatment and Diagnosis; Deputy Director for Clinical and Translational Research; and Head, Oxidative Signaling and Molecular Therapeutics Group, National Cancer Institute
NICOLE F. DOWLING, Associate Director for Science, Division of Cancer Prevention and Control, Centers for Disease Control and Prevention
SCOT W. EBBINGHAUS, Vice President and Therapeutic Area Head, Oncology Clinical Research, Merck Research Laboratories
KOJO S. J. ELENITOBA-JOHNSON, Professor, Perelman School of Medicine; and Director, Center for Personalized Diagnostics and Division of Precision and Computational Diagnostics, University of Pennsylvania
STANTON L. GERSON, Dean and Senior Vice President, Medical Affairs, Case Western Reserve University School of Medicine; Acting Director, Case Comprehensive Cancer Center; Asa & Patricia Shiverick-Jane B. Shiverick (Tripp) Professor of Hematological Oncology and Distinguished University Professor; and Director, National Center for Regenerative Medicine, Case Western Reserve University
JULIE R. GRALOW, Executive Vice President and Chief Medical Officer, American Society of Clinical Oncology
ROY S. HERBST, Ensign Professor of Medicine and Professor of Pharmacology; Director, Center for Thoracic Cancers; Chief of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital; Associate Cancer Center Director, Translational Science, Yale School of Medicine
HEDVIG HRICAK, Chair, Department of Radiology, Memorial Sloan Kettering Cancer Center
CHANITA HUGHES-HALBERT, Vice Chair for Research and Professor, Department of Preventive Medicine; and Associate Director for Cancer Equity, Norris Comprehensive Cancer Center, University of Southern California
ROY A. JENSEN, Professor of Pathology and Laboratory Medicine, Anatomy and Cell Biology, and Cancer Biology; Director, The University of Kansas Cancer Center; William R. Jewell, MD Distinguished Masonic Professor, University of Cancer Medical Center; and Immediate Past President, Association of American Cancer Institutes
RANDY A. JONES, Professor, School of Nursing, and Assistant Director of Community Outreach Recruitment and Engagement, Emily Couric Cancer Center, University of Virginia
BETH Y. KARLAN, Vice Chair, Women’s Health Research; Professor, Department of Obstetrics and Gynecology, David Geffen School of Medicine; and Director, Cancer Population Genetics, Jonsson Comprehensive Cancer Center, University of California, Los Angeles
SAMIR N. KHLEIF, Director, Jeannie and Tony Loop ImmunoOncology Lab; Biomedical Scholar and Professor of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center; and Member, Society for Immunotherapy of Cancer
MIA LEVY, Chief Medical Officer, Foundation Medicine
SCOTT M. LIPPMAN, Director, Moores Cancer Center; Distinguished Professor of Medicine, Senior Associate Dean, and Associate; Vice Chancellor for Cancer Research and Care, and Chugai Pharmaceutical Chair in Cancer, University of California, San Diego
LARISSA NEKHLYUDOV, Professor of Medicine, Harvard Medical School; Internist, Brigham and Women’s Hospital; and Clinical Director, Internal Medicine for Cancer Survivors, Dana-Farber Cancer Institute
RANDALL A. OYER, Medical Director, Oncology, Ann B. Barshinger Cancer Institute; Medical Director, Cancer Risk Evaluation Program, Penn Medicine Lancaster General Health; and Past President, Association of Community Cancer Centers
CLEO A. RYALS, Head of Health Equity and Health Disparities Research, Flatiron Health
RICHARD L. SCHILSKY, Principal Investigator, American Society of Clinical Oncology Targeted Agent and Profiling Utilization Registry Study; and Professor Emeritus, University of Chicago
JULIE SCHNEIDER, Associate Director, Research Strategy and Partnership, Oncology Center of Excellence, Food and Drug Administration
SUSAN M. SCHNEIDER, Associate Professor, Emerita, Duke University School of Nursing
LAWRENCE N. SHULMAN, Professor of Medicine, Deputy Director for Clinical Services, and Director, Center for Global Cancer Medicine, Abramson Cancer Center, University of Pennsylvania
HEIDI SMITH, Vice President and Head, Center of Operations Research and Excellence, U.S. Oncology Medical, Novartis Pharmaceuticals
RACHEL SOLOMON, Senior Director of Policy, Cancer Policy Institute, Cancer Support Community
LARA STRAWBRIDGE, Director, Division of Ambulatory Payment Models, Patient Care Models Group, Center for Medicare and Medicaid Innovation, Centers for Medicare & Medicaid Services
GEORGE J. WEINER, C. E. Block Chair of Cancer Research, Professor of Internal Medicine and Pharmaceutical Science, and Director, Holden Comprehensive Cancer Center, The University of Iowa
ROBERT A. WINN, Director, Massey Cancer Center; Senior Associate Dean for Cancer Innovation; Professor, Pulmonary Disease and Critical Care Medicine; and Lipman Chair in Oncology, School of Medicine, Virginia Commonwealth University
National Cancer Policy Forum Staff
FRANCIS AMANKWAH, Program Officer
RACHEL AUSTIN, Senior Program Assistant
LORI BENJAMIN BRENIG, Research Associate
ANNALEE GONZALES, Administrative Assistant
MICAH WINOGRAD, Senior Finance Business Partner
ERIN BALOGH, Co-Director, National Cancer Policy Forum
SHARYL J. NASS, Co-Director, National Cancer Policy Forum, and Senior Director, Board on Health Care Services
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:
DIETMAR P. BERGER, Sanofi
SHONTA CHAMBERS, Patient Advocate Foundation
INGA T. LENNES, Massachusetts General Hospital
ANAEZE C. OFFODILE II, The University of Texas MD Anderson Cancer Center
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 DANIEL R. MASYS, University of Washington. 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.
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Acknowledgments
Support from the many annual sponsors of the National Academies of Sciences, Engineering, and Medicine’s National Cancer Policy Forum is crucial to the work of the forum. Federal sponsors include the Centers for Disease Control and Prevention and the National Cancer Institute/National Institutes of Health. Non-federal sponsors include the American Association for Cancer Research, American Cancer Society, American College of Radiology, American Society of Clinical Oncology, Association of American Cancer Institutes, Association of Community Cancer Centers, Bristol Myers Squibb, Cancer Support Community, CEO Roundtable on Cancer, Flatiron Health, Merck, National Comprehensive Cancer Network, National Patient Advocate Foundation, Novartis Oncology, Oncology Nursing Society, Pfizer Inc., Sanofi, and Society for Immunotherapy of Cancer.
The forum wishes to express its gratitude to the expert speakers who shared their expertise on the short- and long-term responses to the COVID-19 pandemic, and considered lessons learned from this experience in order to improve the conduct of cancer clinical trials and the delivery of high-quality cancer care in the post-pandemic era. The forum also wishes to thank the members of the planning committee for their work in developing an excellent workshop agenda.
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Contents
CANCER CARE DELIVERY DURING THE COVID-19 PANDEMIC
Adapting Oncology Care Practices
Telehealth in Cancer Care Delivery
Payment Policies and Coverage Adjustments
Organizational Collaboration and Communication
COVID-19 and Social Determinants of Health
ADVANCING CANCER CARE DELIVERY IN A POST-PANDEMIC ERA
The Future of Telehealth in Cancer Care
Addressing Disparities in Access Through Telehealth
Making Cancer Care More Equitable
Payment and Policy Opportunities to Advance Health Equity
Improving Coordination, Communication, and Patient Navigation
Adapting Clinical Cancer Research
Use of Telehealth in Clinical Cancer Research
Adjustments to Federal Policies and Guidelines for Cancer Research
Industry-Sponsored Clinical Trials
Remaining Challenges in the Conduct of Cancer Clinical Trials
ADVANCING CLINICAL CANCER RESEARCH IN A POST-PANDEMIC ERA
Use of Real-World Data for Evidence Generation
The Future Role of Telehealth and Other Modifications in Cancer Clinical Trials
Adapting Clinical Trial Designs
Lessons from the Development of COVID-19 Vaccines
Assessing the Positives and Negatives of Research Modifications
Boxes, Figures, and Table
BOXES
FIGURES
1 The VA TeleOncology hub-and-spokes model for cancer care delivery
2 Virtual clinical trial design within the VA TeleOncology Model
3 Monthly accruals in treatment trials at NCI-designated cancer centers in 2020, relative to 2019
4 Patient accrual in clinical trials, as a percent of 2019 baseline
TABLE
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Acronyms and Abbreviations
| APT | adaptive platform trial |
| ASCO | American Society of Clinical Oncology |
| BMS | Bristol Myers Squibb |
| CDER | Center for Drug Evaluation and Research |
| CMMI | Center for Medicare & Medicaid Innovation |
| CMS | Centers for Medicare & Medicaid Services |
| EHR | electronic health record |
| FDA | Food and Drug Administration |
| HRSA | Health Resources and Services Administration |
| IHS | Indian Health Service |
| IRB | Institutional Review Board |
| NCCN | National Comprehensive Cancer Network |
| NCCS | National Coalition for Cancer Survivorship |
| NCI | National Cancer Institute |
| NIH | National Institutes of Health |
| OCE | Oncology Center of Excellence |
| VA | Department of Veterans Affairs |
