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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2024. Incorporating integrated diagnostics into precision oncology care: Proceedings of a workshop. Washington, DC: The National Academies Press. https://doi.org/10.17226/27744.

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PLANNING COMMITTEE¹

KOJO S. J. ELENITOBA-JOHNSON (Co-Chair), Memorial Sloan Kettering Cancer Center

HEDVIG HRICAK (Co-Chair), Memorial Sloan Kettering Cancer Center

CHRISTINA CHAPMAN, Baylor College of Medicine

NANCY E. DAVIDSON, University of Washington

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

BETH Y. KARLAN, University of California, Los Angeles

MIA LEVY, Foundation Medicine, Inc.

AANAND D. NAIK, University of Texas Health Sciences Center at Houston

WENDY NILSEN, National Science Foundation

JASON M. SLAGLE, Vanderbilt University

Project Staff

ANNA ADLER, Senior Program Assistant (from September 2023)

LORI BENJAMIN BRENIG, Research Associate (until May 2023)

TORRIE BROWN, Program Coordinator

CHIDINMA CHUKWURAH, Senior Program Assistant (until April 2024)

THO NGUYEN, Senior Program Officer, Computer Science and Telecommunications Board

DANIEL TALMAGE, Program Officer, Board on Human-System Integration

EMMA WICKLAND, Research Associate (from September 2023)

JULIE WILTSHIRE, Senior Finance Business Partner

JENNIFER ZHU, Associate Program Officer (from January 2023)

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

NATIONAL CANCER POLICY FORUM¹

ROBERT A. WINN (Chair), Virginia Commonwealth University

PETER C. ADAMSON, Sanofi

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

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

National Cancer Policy Forum Staff

ANNA ADLER, Senior Program Assistant

TORRIE BROWN, Program Coordinator

CHIDINMA CHUKWURAH, Senior Program Assistant (until April 2024)

JULIE WILTSHIRE, Senior Finance Business Partner

EMMA WICKLAND, Research Associate

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; 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:

JOCHEN K. LENNERZ, BostonGene

MY T. THAI, University of Florida

MARY M. ZUTTER, Vanderbilt University Medical 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 MICHELLE LE BEAU, Cancer Prevention and Research Institute of Texas. She was responsible for making certain that an independent examination of this proceedings was carried out in accordance with the 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.

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; Bristol Myers Squibb; Cancer Support Community; Flatiron Health; Merck & Co., Inc.; National Comprehensive Cancer Network; National Patient Advocate Foundation; Novartis Oncology; Oncology Nursing Society; Partners in Health; Pfizer Inc.; Sanofi; and Society for Immunotherapy of Cancer.

The forum wishes to express its gratitude to the expert speakers whose presentations and discussions helped inform efforts to advance progress in the development and use of integrated diagnostics for precision oncology care. The forum also wishes 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 THE CURRENT STATUS OF AND VISION FOR INTEGRATED DIAGNOSTICS

An Evolving Integrated Data Science Approach to Personalized Oncology Care

An Expanding Role for AI

Implementation Challenges

Efforts to Improve Interoperability

EFFORTS TO DEVELOP, IMPLEMENT, AND USE INTEGRATED DIAGNOSTICS

Perspectives from Academic Medical Centers

Perspectives from Industry

Perspectives from Large Health Care Organizations

IMPROVING EVIDENCE GENERATION FOR INTEGRATED DIAGNOSTICS

A Cancer Risk Management Learning System for Evidence Generation

Building the Evidence Generation Infrastructure to Scale Precision Diagnostics

Opportunities to Leverage EHRs for Clinical Evidence Generation

Lessons from American Association for Cancer Research Project GENIE to Inform Evidence Generation

The Role of Equitable Access in the Diversity of Registry Data

DESIGN AND USE OF INTEGRATED DIAGNOSTICS

Ethical AI by Design

A Diagnostic Management Team Approach to Reducing Diagnostic Errors

Multimodal Data Integration for Research and Clinical Practice

Implementing Integrated Diagnostics into Precision Oncology Care

Trust and Acceptance of AI in Clinical Settings

Risk Communication and Decision Support

Reproducibility of ML Models for Integrated Diagnostics

Overcoming Design and Use Challenges

REGULATORY OVERSIGHT AND INSURANCE COVERAGE OF INTEGRATED DIAGNOSTICS

Pathways for Regulatory Review of Integrated Diagnostics

Coverage Considerations for Integrated Diagnostics

ENSURING PATIENT ACCESS AND PROMOTING HEALTH EQUITY

Developing Equitable AI Algorithms

Integrated Diagnostics in Community-Based Settings of Care

Promoting Health Equity Through Patient Access to Integrated Diagnostics

Understanding and Addressing Disparities in Access and Use

CURRENT FEDERAL INITIATIVES IN PRECISION CANCER CARE

NCI Precision Medicine Cancer Trials

ARPA-H and Cancer Moonshot

Promoting a Culture of Data Sharing

REFLECTING ON THE WORKSHOP DISCUSSIONS

Envisioning the Future for Integrated Diagnostics

Highlighting Insights from Academia, Industry, and Health Care Organizations

Improving Evidence Generation

Enhancing Design and Use of Integrated Diagnostics

Regulatory Oversight and Insurance Coverage

Access and Equity

REFERENCES

APPENDIX A Statement of Task

APPENDIX B Workshop Agenda

Boxes, Figures, and Table

BOXES

1 Observations on the Development and Use of Integrated Diagnostics in Cancer Care Made by Individual Workshop Participants

2 Opportunities to Advance the Development, Implementation, and Use of Integrated Diagnostics in Precision Cancer Care Suggested by Individual Workshop Participants

3 FDA Risk Classification–Based Review Pathways

4 Overview of the NCI-MATCH Precision Cancer Medicine Trial

5 Overview of ARPA-H

FIGURES

1 Integrated data science approach to personalized treatment

2 Examples of where patient data are generated across the health grid

3 Implementation of a breast cancer risk management learning system

4 Integrated real-world evidence generation platform

TABLE

1 Settings of Cancer Care in the United States

Acronyms and Abbreviations