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Principles for Good Practice in the Conduct of Non-interventional Studies: The View of Industry Researchers

This reflection paper presents a consolidated view of EFPIA on the need for principles for good practice in the generation and use of non-interventional studies (NIS), including overarching principles such as the registration of hypothesis evaluating treatment effect (HETE) studies. We first define...

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Detalles Bibliográficos
Autores principales: Acha, Virginia, Barefoot, Bart, Juarez Garcia, Ariadna, Lehner, Valerie, Monno, Raffaella, Sandler, Susan, Spooner, Almath, Verpillat, Patrice
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10579109/
https://www.ncbi.nlm.nih.gov/pubmed/37460826
http://dx.doi.org/10.1007/s43441-023-00544-y