Clinical Trials That Leverage External Data: Do We Need More Transparent Protocols and Statistical Plans?

Oncology is experiencing a growing interest in the use of external control (EC) data for the design and analysis of clinical trials [2,6]. Data from EC patients may be used in a variety of tasks, for example for the analysis of single arm studies [4] or for early futility stopping of randomized trials [9]. The rationale for incorporating EC data into clinical trials is typically to increase the efficiency of the drug development process. For example, consider newly diagnosed glioblastoma (GBM) patients.
Source: European Journal of Cancer - Category: Cancer & Oncology Authors: Tags: Letter to the Editor Source Type: research