Proceedings of a Workshop

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This activity was supported by Contract No. 75D30121D11240 (Task Order Nos. 75D30122F00005 and 75D30123F00024) with the Centers for Disease Control and Prevention; Contract No. HHSN263201800029I (Task Order Nos. HHSN26300007, HHSN26300008, 75N98023F00019, and 75N98023F00020) with the National Institutes of Health (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, and Office of the Director); and Grant No. 1R13FD007302-01 with the U.S. Food and Drug Administration. This activity was also supported by the American Association for Cancer Research; American Cancer Society; American College of Radiology; American Society of Clinical Oncology; Amgen Inc.; Association of American Cancer Institutes; Association of American Medical Colleges; Association of Community Cancer Centers; AstraZeneca; Biogen; Burroughs Wellcome Fund; Critical Path Institute; Eli Lilly and Company; FasterCures, Milken Institute; Flatiron Health; Foundation for the National Institutes of Health; Friends of Cancer Research; Johnson & Johnson; Medable, Inc.; Merck; National Comprehensive Cancer Network; National Patient Advocate Foundation; New England Journal of Medicine; Novartis Oncology; Oncology Nursing Society; Partners in Health; 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: 978-0-309-71868-4
International Standard Book Number-10: 0-309-71868-6
Digital Object Identifier: https://doi.org/10.17226/27758

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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2024. Optimizing public–private partnerships for clinical cancer research: Proceedings of a workshop. Washington, DC: The National Academies Press. https://doi.org/10.17226/27758.

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PLANNING COMMITTEE¹

ROY S. HERBST (Co-Chair), Yale University

RICHARD L. SCHILSKY (Co-Chair), University of Chicago

GIDEON BLUMENTHAL, Merck

OTIS W. BRAWLEY, Johns Hopkins University

CHANITA HUGHES-HALBERT, University of Southern California

SAMIR N. KHLEIF, Georgetown University Medical Center

ESTHER KROFAH, Milken Institute and FasterCures

SCOTT M. LIPPMAN, University of California, San Diego

NEAL MEROPOL, Flatiron Health

EDITH PEREZ, Mayo Clinic and Bolt Biotherapeutics

KRISTEN ROSATI, Coppersmith Brockelman PLC

LAWRENCE N. SHULMAN, University of Pennsylvania

HEIDI SMITH, Novartis Pharmaceuticals

ROBERT WINN, Virginia Commonwealth University

Project Staff

ANNA ADLER, Senior Program Assistant

TORRIE BROWN, Program Coordinator

CHIDINMA CHUKWURAH, Senior Program Assistant (until April 2024)

EMMA WICKLAND, Research Associate

JULIE WILTSHIRE, Senior Finance Business Partner

JENNIFER ZHU, Associate Program Officer

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

ERIN BALOGH, Co-Director, National Cancer Policy Forum (until June 2024)

LAURENE GRAIG, Senior Program Officer (June–July 2024)

FRANCIS AMANKWAH, Co-Director, National Cancer Policy Forum (from July 2024)

SHARYL NASS, Co-Director, National Cancer Policy Forum; Senior Director, Board on Health Care Services

___________________

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.

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NATIONAL CANCER POLICY FORUM¹

ROBERT A. WINN (Chair), Virginia Commonwealth University

JUSTIN E. BEKELMAN, University of Pennsylvania

SMITA BHATIA, The University of Alabama at Birmingham

GIDEON BLUMENTHAL, Merck

CHRIS BOSHOFF, Pfizer Inc.

OTIS W. BRAWLEY, Johns Hopkins University

CHRISTINA CHAPMAN, Baylor College of Medicine; Michael E. DeBakey VA Medical Center

GWEN DARIEN, National Patient Advocate Foundation

CRYSTAL DENLINGER, National Comprehensive Cancer Network

JAMES H. DOROSHOW, National Cancer Institute

S. GAIL ECKHARDT, Baylor College of Medicine

CHRISTOPHER R. FRIESE, University of Michigan

STANTON L. GERSON, Case Western Reserve University

SCARLETT LIN GOMEZ, University of California, San Francisco

JULIE R. GRALOW, American Society of Clinical Oncology

ROY S. HERBST, Yale University; American Association for Cancer Research

HEDVIG HRICAK, Memorial Sloan Kettering Cancer Center

CHANITA HUGHES-HALBERT, University of Southern California

ROY A. JENSEN, University of Kansas; Association of American Cancer Institutes

RANDY A. JONES, University of Virginia

BETH Y. KARLAN, University of California, Los Angeles

SAMIR N. KHLEIF, Georgetown University; Society for Immunotherapy of Cancer

SCOTT M. LIPPMAN, University of California, San Diego

ELENA MARTINEZ, University of California, San Diego

LARISSA NEKHLYUDOV, Brigham and Women’s Hospital; Dana-Farber Cancer Institute; Harvard Medical School

RANDALL A. OYER, University of Pennsylvania; Penn Medicine Lancaster General Health; Association of Community Cancer Centers

CLEO A. RYALS, Flatiron Health

___________________

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.

RICHARD L. SCHILSKY, ASCO TAPUR Study; University of Chicago

JULIE SCHNEIDER, Oncology Center of Excellence, U.S. Food and Drug Administration

SUSAN M. SCHNEIDER, Duke University

LAWRENCE N. SHULMAN, University of Pennsylvania

HEIDI SMITH, Novartis Pharmaceuticals

KATRINA TRIVERS, Centers for Disease Control and Prevention

ROBIN YABROFF, American Cancer Society

Forum Staff

ANNA ADLER, Senior Program Assistant

TORRIE BROWN, Program Coordinator

CHIDINMA CHUKWURAH, Senior Program Assistant (until April 2024)

EMMA WICKLAND, Research Associate

JULIE WILTSHIRE, Senior Finance Business Partner

JENNIFER ZHU, Associate Program Officer

ERIN BALOGH, Co-Director, National Cancer Policy Forum (until June 2024)

LAURENE GRAIG, Senior Program Officer (June–July 2024)

FRANCIS AMANKWAH, Co-Director, National Cancer Policy Forum (from July 2024)

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

FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION¹

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

ANN TAYLOR (Co-Chair), Retired

BARBARA E. BIERER, Harvard Medical School; Brigham and Women’s Hospital

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

JOHN BUSE, University of North Carolina, Chapel Hill School of Medicine

LUTHER T. CLARK, Merck

BARRY S. COLLER, The Rockefeller University

TAMMY R.L. COLLINS, Burroughs Wellcome Fund

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, Retired

CARLOS O. GARNER, Eli Lilly and Company

SALLY L. HODDER, West Virginia University

TESHEIA JOHNSON, Yale School of Medicine

LYRIC JORGENSON, Office of the Director, National Institutes of Health

ESTHER KROFAH, FasterCures, Milken Institute

LISA M. LAVANGE, University of North Carolina

ARAN MAREE, Johnson & Johnson

CRISTIAN MASSACESI, AstraZeneca

ROSS MCKINNEY JR., Association of American Medical Colleges

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

___________________

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.

ANAEZE C. OFFODILE II, Memorial Sloan Kettering Center

SALLY OKUN, Clinical Trials Transformation Initiative

ARTI RAI, Duke University School of Law

KLAUS ROMERO, Critical Path Institute

JONI RUTTER, National Center for Advancing Translational Sciences, National Institutes of Health

SUSAN SCHAEFFER, The Patients’ Academy for Research Advocacy

ANANTHA SHEKHAR, University of Pittsburgh School of Medicine

ELLEN V. SIGAL, Friends of Cancer Research

MARK TAISEY, Amgen Inc.

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

PAMELA TENAERTS, Medable, Inc.

MAJID VAKILYNEJAD, Takeda

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

ALASTAIR WOOD, Vanderbilt University

CRIS WOOLSTON, Sanofi

JOSEPH C. WU, Stanford University School of Medicine

Forum Staff

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

KYLE CAVAGNINI, Associate Program Officer

BRITTANY HSIAO, Associate Program Officer (until March 2024)

MAYA THIRKILL, Associate Program Officer (until April 2023)

NOAH ONTJES, Associate Program Officer

MELVIN JOPPY, Senior Program Assistant

CLARE STROUD, Senior Director, Board on Health Sciences Policy

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:

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

The National Cancer Policy Forum is grateful for the support of our many annual sponsors. Federal sponsors include the Centers for Disease Control and Prevention and the National Cancer Institute/National Institutes of Health. Nonfederal 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, Flatiron Health, Merck, National Comprehensive Cancer Network, National Patient Advocate Foundation, Novartis Oncology, Oncology Nursing Society, Partners in Health, Pfizer Inc., and Society for Immunotherapy of Cancer.

The Forum on Drug Discovery, Development, and Translation is also appreciative of the support from our many annual sponsors. Federal sponsors include the National Institutes of Health (National Cancer Institute, National Institute on Allergy and Infectious Diseases, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, and Office of Science Policy) and the U.S. Food and Drug Administration. Nonfederal sponsors include Amgen, Inc.; Association of American Medical Colleges; AstraZeneca; Biogen; Burroughs Wellcome Fund; Critical Path Institute; Eli Lilly and Company; FasterCures, Milken Institute; Foundation for the National Institutes of Health; Friends of Cancer Research; Johnson & Johnson; Medable, Inc.; Merck; New England Journal of Medicine; and Sanofi.

The forums wish to express their gratitude to the expert speakers whose presentations and discussions helped examine opportunities to improve the

care and outcomes for patients with cancer through public–private partnerships for clinical cancer research. The forums also wish to thank the members of the planning committee for their work in developing an excellent workshop agenda.

Contents

Acronyms and Abbreviations

Proceedings of a Workshop

WORKSHOP OVERVIEW

OVERVIEW OF PUBLIC–PRIVATE PARTNERSHIPS TO ADVANCE CLINICAL CANCER RESEARCH

Developing Successful Public–Private Partnerships

REALIZING THE POTENTIAL OF PUBLIC–PRIVATE PARTNERSHIPS IN CLINICAL CANCER RESEARCH

Diversifying Clinical Trials and Reducing Health Disparities

Potential for Impact on Cancer Outcomes That Matter to Patients

NAVIGATING CHALLENGES IN PUBLIC–PRIVATE PARTNERSHIPS FOR CLINICAL CANCER RESEARCH

Overcoming Operations Challenges to Accelerate Partnership Success

Regulatory and Policy Hurdles

Overcoming Data Sharing Challenges Within Public–Private Partnerships

EMBEDDING RESEARCH IN CARE DELIVERY

HIGHLIGHTING OPPORTUNITIES TO IMPROVE PUBLIC–PRIVATE PARTNERSHIPS FOR CLINICAL CANCER RESEARCH

Building Trust and Alignment Among Partners

Improving Patient Engagement, Trust, and Diversity

Optimizing Data Sharing

Creating Sustainable Public–Private Partnership Models and Developing the Workforce

REFERENCES

APPENDIXES

A Statement of Task

B Workshop Agenda

Boxes and Figures

BOXES

1 Observations on Public–Private Partnerships for Clinical Cancer Research Made by Individual Workshop Participants

2 Strategies for Advancing Public–Private Partnerships for Clinical Cancer Research Suggested by Individual Workshop Participants

3 Examples of Trials Conducted via Public–Private Partnerships in Oncology

FIGURES

1 Partnership phases of the Foundation for the National Institutes of Health

2 Challenges in the landscape of routine cancer care and clinical trials and their downstream effects

3 Goals of the Clinical Trials Transformation Initiative 2030

4 Key components of an individual-participant data package from a clinical trial to facilitate independent research

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Acronyms and Abbreviations