Using numerical modeling and simulation to assess the ethical burden in clinical trials and how it relates to the proportion of responders in a trial sample

• Jean-Pierre Boissel ,

  Contributed equally to this work with: Jean-Pierre Boissel, David Pérol, Hervé Décousus, Ingrid Klingmann, Marc Hommel

  Roles Conceptualization, Data curation, Formal analysis, Methodology, Project administration, Software, Supervision, Validation, Visualization, Writing – original draft, Writing – review & editing

  * E-mail: jean-pierre.boissel@novadiscovery.com

  Affiliation Novadiscovery, Lyon, France

  https://orcid.org/0000-0001-8938-2284

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• David Pérol ,

  Contributed equally to this work with: Jean-Pierre Boissel, David Pérol, Hervé Décousus, Ingrid Klingmann, Marc Hommel

  Roles Validation, Visualization, Writing – review & editing

  Affiliation Department of Biostatistics, Centre Léon Bérard, Lyon, France

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• Hervé Décousus ,

  Contributed equally to this work with: Jean-Pierre Boissel, David Pérol, Hervé Décousus, Ingrid Klingmann, Marc Hommel

  Roles Validation, Visualization, Writing – review & editing

  Affiliation INSERM, CIC 1408—F Crin, INNOVTE, CHU Saint-Etienne, Hôpital Nord, Service Médecine Vasculaire et Thérapeutique, Saint Etienne, France

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• Ingrid Klingmann ,

  Contributed equally to this work with: Jean-Pierre Boissel, David Pérol, Hervé Décousus, Ingrid Klingmann, Marc Hommel

  Roles Project administration, Validation, Visualization, Writing – review & editing

  Affiliation European Forum for Good Clinical Practice (EFGCP), Brussels, Belgium

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• Marc Hommel

  Contributed equally to this work with: Jean-Pierre Boissel, David Pérol, Hervé Décousus, Ingrid Klingmann, Marc Hommel

  Roles Funding acquisition, Project administration, Validation, Visualization, Writing – review & editing

  Affiliations Novadiscovery, Lyon, France, University Hospital Grenoble, Grenoble, EA 4407 AGEIS UGA, France

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