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.

中文翻译：

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药品早期获取计划：现实世界的数据收集。

批准前阶段产生的真实数据（RWD）可以补充主要的临床试验结果；但是，正如我们在此处讨论的那样，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。