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Methods for safety and endpoint ascertainment: identification of adverse events through scrutiny of negatively adjudicated events

BACKGROUND: The primary goal of phase 2 and 3 clinical trials is to evaluate the safety and effectiveness of therapeutic interventions, and efficient and reproducible ascertainment of important clinical events, either as clinical outcome events (COEs) or adverse events (AEs), is critical. Clinical o...

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Detalles Bibliográficos
Autores principales: Fanaroff, Alexander C., Haque, Ghazala, Thomas, Betsy, Stone, Allegra E., Perkins, Lynn M., Wilson, Matthew, Jones, W. Schuyler, Melloni, Chiara, Mahaffey, Kenneth W., Alexander, Karen P., Lopes, Renato D.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7147037/
https://www.ncbi.nlm.nih.gov/pubmed/32272961
http://dx.doi.org/10.1186/s13063-020-04254-w