Clinical Pharmacology Applications of Real‐World Data and Real‐World Evidence in Drug Development and Approval–An Industry Perspective

Since the 21st Century Cures Act was signed into law in 2016, real‐world data (RWD) and real‐world evidence (RWE) have attracted great interest from the healthcare ecosystem globally. The potential and capability of RWD/RWE to inform regulatory decisions and clinical drug development have been exten...

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Published in:Clinical pharmacology and therapeutics 2023-10, Vol.114 (4), p.751-767
Main Authors: Zhu, Rui, Vora, Bianca, Menon, Sujatha, Younis, Islam, Dwivedi, Gaurav, Meng, Zhaoling, Datta‐Mannan, Amita, Manchandani, Pooja, Nayak, Satyaprakash, Tammara, Brinda K., Garhyan, Parag, Iqbal, Shahed, Dagenais, Simon, Chanu, Pascal, Mukherjee, Arnab, Ghobadi, Cyrus
Format: Article
Language:English
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