Search Results - "Mercado, Tiffany"

Effectively Leveraging RWD for External Controls: A Systematic Literature Review of Regulatory and HTA Decisions by Sola‐Morales, Oriol, Curtis, Lesley H., Heidt, Julien, Walsh, Laura, Casso, Deborah, Oliveria, Susan, Saunders‐Hastings, Patrick, Song, Yufei, Mercado, Tiffany, Zusterzeel, Robbert, Mastey, Vera, Harnett, James, Quek, Ruben G. W.

“…Real‐world data (RWD)‐derived external controls can be used to contextualize efficacy findings for investigational therapies evaluated in uncontrolled trials…”
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Regulatory and HTA Considerations for Development of Real‐World Data Derived External Controls by Curtis, Lesley H., Sola‐Morales, Oriol, Heidt, Julien, Saunders‐Hastings, Patrick, Walsh, Laura, Casso, Deborah, Oliveria, Susan, Mercado, Tiffany, Zusterzeel, Robbert, Sobel, Rachel E., Jalbert, Jessica J., Mastey, Vera, Harnett, James, Quek, Ruben G. W.

“…Regulators and Health Technology Assessment (HTA) bodies are increasingly familiar with, and publishing guidance on, external controls derived from real‐world…”
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