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Detection of Fraud in a Clinical Trial Using Unsupervised Statistical Monitoring

BACKGROUND: A central statistical assessment of the quality of data collected in clinical trials can improve the quality and efficiency of sponsor oversight of clinical investigations. MATERIAL AND METHODS: The database of a large randomized clinical trial with known fraud was reanalyzed with a view...

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Detalles Bibliográficos
Autores principales: de Viron, Sylviane, Trotta, Laura, Schumacher, Helmut, Lomp, Hans-Juergen, Höppner, Sebastiaan, Young, Steve, Buyse, Marc
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8688378/
https://www.ncbi.nlm.nih.gov/pubmed/34590286
http://dx.doi.org/10.1007/s43441-021-00341-5