Bristol-Myers Squibb Pharmaceuticals Ltd., London, UK.
Evidera, London, UK.
Drug Discov Today. 2019 Dec;24(12):2231-2233. doi: 10.1016/j.drudis.2019.06.009. Epub 2019 Jun 19.
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.
真实世界数据(RWD)在批准前阶段产生,可以作为主要临床试验结果的补充;然而,正如我们在这里讨论的,需要一个数据收集框架来确保这些数据的有效性和适用性。