A joint industry‐sponsored data monitoring committee model for observational, retrospective drug safety studies in the real‐world setting

PURPOSE: To share better practice in establishing data monitoring committees (DMCs) for observational, retrospective safety studies with joint‐industry sponsorship. METHODS: A DMC model was created to monitor data from an observational, retrospective, post‐authorization safety study investigating ri...

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Publicado en:Pharmacoepidemiol Drug Saf
Autores principales: Major‐Pedersen, Atheline, McCullen, Mary Kate, Sabol, Mary Elizabeth, Adetunji, Omolara, Massaro, Joseph, Neugut, Alfred I., Sosa, Julie Ann, Hollenberg, Anthony N.
Formato: Artigo
Lenguaje:Inglês
Publicado: John Wiley & Sons, Inc. 2020
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Original Article
Acceso en línea:https://ncbi.nlm.nih.gov/pmc/articles/PMC8247341/
https://ncbi.nlm.nih.gov/pubmed/33179845
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/pds.5172
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