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A Structured Preapproval and Postapproval Comparative Study Design Framework to Generate Valid and Transparent Real‐World Evidence for Regulatory Decisions
Real‐world evidence provides important information about the effects of medicines in routine clinical practice. To engender trust that evidence generated for regulatory purposes is sufficiently valid, transparency in the reasoning that underlies study design decisions is critical. Building on existi...
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| I publikationen: | Clin Pharmacol Ther |
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| Huvudupphovsmän: | , , |
| Materialtyp: | Artigo |
| Språk: | Inglês |
| Publicerad: |
John Wiley and Sons Inc.
2019
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| Ämnen: | |
| Länkar: | https://ncbi.nlm.nih.gov/pmc/articles/PMC6771466/ https://ncbi.nlm.nih.gov/pubmed/31025311 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/cpt.1480 |
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