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Advancing a Framework for Regulatory Use of Real-World Evidence: When Real Is Reliable
There is growing interest in regulatory use of randomized pragmatic trials and noninterventional real-world (RW) studies of effectiveness and safety, but there is no agreed-on framework for assessing when this type of evidence is sufficiently reliable. Rather than impose a clinical trial–like paradi...
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| Publicado no: | Ther Innov Regul Sci |
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| Autor principal: | |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
SAGE Publications
2018
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC5944086/ https://ncbi.nlm.nih.gov/pubmed/29714575 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/2168479018763591 |
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