Clinical Utility Workgroup

The Clinical Utility Workgroup will engage and leverage the knowledge of the broader healthcare community— including regulators, guidelines developers, clinicians and academics, payers, and patients, as well as public-health, health-economics, and other subject-matter experts—to design interim clinical utility frameworks for using MCED technologies as a screen for asymptomatic individuals and a diagnostic for symptomatic patients. These frameworks will identify the specific cancers and populations for which the benefits of the tests outweigh the harms and propose pragmatic approaches for evidence generation. The frameworks will segment the cancers included in MCED tests into manageable groups, consider currently established endpoints and measurements, and be updated as further evidence related to MCED technologies is generated and published.

Please read our latest Guidance and visit our Workgroup Resources page for information from our other workgroups.

 Workgroup Leadership

  • Sean Tunis, MD, MSc.

    US Chair
    Principal
    Rubix Health

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  • Brian Nicholson, MRCGP MSc (Health Res) DPhil

    UK Co-Chair Associate Professor Nuffield Department of Primary Care Health Sciences, University of Oxford

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 Workgroup Membership

  • Brian Allen

    Vice President, Clinical Development
    Adela

  • Tomasz Beer, MD

    Vice President & Chief Medical Officer, Multicancer Early Detection
    Exact Sciences

  • Alexander Borowsky, MD

    Director of Molecular Diagnostics
    UC Davis Health

  • Gaby Dieguez

    Principal & Consulting Actuary
    Milliman

  • Tina Clarke Dur

    Epidemiology, Vice President
    GRAIL

  • Ruth Etzioni

    Professor
    Public Health Sciences Division, Fred Hutch Cancer Center

  • Alice Brookes, PhD

    Strategic Evidence Manager Cancer Research UK

  • Eric Klein

    Distinguished Scientist
    GRAIL

  • Donna Messner

    Principal
    DA Messner Consulting, LLC

  • Robert Smith

    Senior Vice President for Cancer Screening
    American Cancer Society

  • Dax Kurbegov, MD

    Vice President & Physician-in-Chief of Clinical Programs Sarah Cannon Cancer Institute

  • Nima Nabavizadeh, MD

    Residency Program Director, Radiation Oncology Department

    Director of Cancer Early Detection Advanced Research Center (CEDAR), Oregon Health and Science University

  • Wendy Rubenstein, MD PhD

    Senior Scientific Officer, Division of Cancer Prevention National Cancer Institute

  • Christina Clarke Dur, PhD, MPH

    Vice President, Epidemiology and Distinguished Scientist GRAIL

  • Jeff Allen

    President & CEO Friends of Cancer Research

  • Max Parmar

    Professor of Medical Statistics and Epidemiology, Director of MRC Clinical Trials Unit University College London

  • Samantha Harrison

    Head of Strategic Evidence Cancer Research UK

  • Anand Pathak, MD, PHD, MPH

    Medical Officer Food and Drug Administration

  • Donna Roscoe, PhD

    Division Director, Molecular Genetics and Pathology Division, Office of In Vitro Diagnostics and Radiological Health Food and Drug Administration