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.

Boissel, Jean-Pierre; Pérol, David; Décousus, Hervé; Klingmann, Ingrid; Hommel, Marc

Boissel, Jean-Pierre; Pérol, David; Décousus, Hervé; Klingmann, Ingrid; Hommel, Marc.

Affiliation

Boissel JP; Novadiscovery, Lyon, France.
Pérol D; Department of Biostatistics, Centre Léon Bérard, Lyon, France.
Décousus H; INSERM, CIC 1408-F Crin, INNOVTE, CHU Saint-Etienne, Hôpital Nord, Service Médecine Vasculaire et Thérapeutique, Saint Etienne, France.
Klingmann I; European Forum for Good Clinical Practice (EFGCP), Brussels, Belgium.
Hommel M; Novadiscovery, Lyon, France.

PLoS One ; 16(10): e0258093, 2021.

Article in En | MEDLINE | ID: mdl-34634062

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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Randomized Controlled Trials as Topic Type of study: Clinical_trials Aspects: Ethics Language: En Journal: PLoS One Journal subject: CIENCIA / MEDICINA Year: 2021 Document type: Article Affiliation country: Francia Country of publication: Estados Unidos

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