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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...
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| Publicado no: | Contemp Clin Trials Commun |
|---|---|
| Main Authors: | , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Elsevier
2019
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC6883292/ https://ncbi.nlm.nih.gov/pubmed/31799472 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.conctc.2019.100477 |
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