Early Access to Medicines Scheme: real-world data collection

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Early Access to Medicines Scheme: real-world data collection

Pang, Hok; Wang, Meng; Kiff, Christopher; Soni, Mira; Stein, Dara; Tyas, David

Drug discovery today, 12/2019, Volume: 24, Issue: 12

Journal Article

Real-world data (RWD) generated during the pre-approval phase could be supplementary to primary clinical trial outcomes; however, as we discuss here, a data collection framework is needed to ensure the validity and applicability of these data.

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