Implications of product withdrawal on a post-approval pragmatic trial: The VOLUME study experience

INTRODUCTION: Many clinical trials terminate early due to safety and efficacy concerns, and less often due to unexpected “positive” findings. However, early termination of post-approval (Phase IV) pragmatic randomized trials for commercial reasons is less frequent, may be more complex, and may requi...

Descripción completa

Detalles Bibliográficos
Autores principales: Kolitsopoulos, Francesca M., Gatto, Nicolle M., Sweetland, Kevin, Bracken, Michael B., Jackson, Neville
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2019
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6883292/
https://www.ncbi.nlm.nih.gov/pubmed/31799472
http://dx.doi.org/10.1016/j.conctc.2019.100477

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6883292/
https://www.ncbi.nlm.nih.gov/pubmed/31799472
http://dx.doi.org/10.1016/j.conctc.2019.100477

Ejemplares similares