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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...
Autores principales: | Kolitsopoulos, Francesca M., Gatto, Nicolle M., Sweetland, Kevin, Bracken, Michael B., Jackson, Neville |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2019
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Materias: | |
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 |
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