A framework for assessing the impact of accelerated approval

• A. Lawrence Gould ,

  Roles Conceptualization, Investigation, Methodology, Visualization, Writing – original draft, Writing – review & editing

  * E-mail: goulda@merck.com

  Affiliation Methodology Research, BARDS, Merck & Co., Inc., Kenilworth, New Jersey, United States of America

  https://orcid.org/0000-0002-9661-4474

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• Robert K. Campbell,

  Roles Conceptualization, Project administration, Visualization, Writing – original draft, Writing – review & editing

  Affiliation Molecular Pharmacology, Physiology and Biotechnology, Brown University, Providence, Rhode Island, United States of America

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• John W. Loewy,

  Roles Investigation, Visualization, Writing – review & editing

  Affiliation DataForethought, Winchester, Massachusetts, United States of America

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• Robert A. Beckman,

  Roles Conceptualization, Visualization, Writing – review & editing

  Affiliation Lombardi Comprehensive Cancer Center and Innovation Center for Biomedical Informatics, Georgetown University Medical Center, Washington, DC, United States of America

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• Jyotirmoy Dey,

  Roles Visualization, Writing – review & editing

  Affiliation Data and Statistical Sciences, AbbVie, North Chicago, Illinois, United States of America

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• Anja Schiel,

  Roles Conceptualization, Writing – review & editing

  Affiliation Department for Pharmacoeconomics, Norwegian Medicines Agency, Oslo, Norway

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• Carl-Fredrik Burman,

  Roles Conceptualization, Writing – review & editing

  Affiliation Data Science & AI, AstraZeneca R&D, Gothenburg, Sweden

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• Joey Zhou,

  Roles Writing – review & editing

  Affiliation Xcovery Pharmaceuticals, Palm Beach Gardens, Florida, United States of America

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• Zoran Antonijevic,

  Roles Conceptualization, Visualization, Writing – original draft, Writing – review & editing

  Affiliation Abond CRO, Allendale, Michigan, United States of America

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• Eva R. Miller,

  Roles Visualization, Writing – review & editing

  Affiliation Independent Biostatistical Consultant, Middletown Twp, Pennsylvania, United States of America

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• Rui Tang

  Roles Writing – review & editing

  Affiliation Methodology and Data Visualization, Biostatistics Department, Servier Pharmaceuticals US, Boston, Massachusetts, United States of America

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