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Drug safety assessment in clinical trials: methodological challenges and opportunities
Randomized controlled trials are the principal means of establishing the efficacy of drugs. However pre-marketing trials are limited in size and duration and exclude high-risk populations. They have limited statistical power to detect rare but potentially serious adverse events in real-world patient...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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BioMed Central
2012
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3502602/ https://www.ncbi.nlm.nih.gov/pubmed/22906139 http://dx.doi.org/10.1186/1745-6215-13-138 |