Preclinical efficacy studies in investigator brochures: Do they enable risk–benefit assessment?

• Susanne Wieschowski,

  Roles Conceptualization, Formal analysis, Investigation, Methodology, Writing – review & editing

  Affiliation Institute for Ethics, History, and Philosophy of Medicine, Hannover Medical School, Hannover, Germany

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• William Wei Lim Chin,

  Roles Conceptualization, Formal analysis, Investigation, Methodology, Writing – review & editing

  Affiliation Institute for Ethics, History, and Philosophy of Medicine, Hannover Medical School, Hannover, Germany

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• Carole Federico,

  Roles Conceptualization, Investigation, Methodology, Writing – review & editing

  Affiliation Studies of Translation, Ethics, and Medicine (STREAM), Biomedical Ethics Unit, McGill University, Montreal, Québec, Canada

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• Sören Sievers,

  Roles Formal analysis, Investigation, Writing – review & editing

  Affiliation Institute for Ethics, History, and Philosophy of Medicine, Hannover Medical School, Hannover, Germany

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• Jonathan Kimmelman,

  Roles Conceptualization, Methodology, Supervision, Writing – review & editing

  Affiliation Studies of Translation, Ethics, and Medicine (STREAM), Biomedical Ethics Unit, McGill University, Montreal, Québec, Canada

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• Daniel Strech

  Roles Conceptualization, Funding acquisition, Methodology, Project administration, Supervision, Validation, Writing – original draft, Writing – review & editing

  * E-mail: strech.daniel@mh-hannover.de

  Affiliation Institute for Ethics, History, and Philosophy of Medicine, Hannover Medical School, Hannover, Germany

  http://orcid.org/0000-0002-9153-079X

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