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Trial designs using real‐world data: The changing landscape of the regulatory approval process
PURPOSE: There is a need to develop hybrid trial methodology combining the best parts of traditional randomized controlled trials (RCTs) and observational study designs to produce real‐world evidence (RWE) that provides adequate scientific evidence for regulatory decision‐making. METHODS: This revie...
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| 發表在: | Pharmacoepidemiol Drug Saf |
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| Main Authors: | , , , , |
| 格式: | Artigo |
| 語言: | Inglês |
| 出版: |
John Wiley and Sons Inc.
2019
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| 主題: | |
| 在線閱讀: | https://ncbi.nlm.nih.gov/pmc/articles/PMC7687110/ https://ncbi.nlm.nih.gov/pubmed/31823482 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/pds.4932 |
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