The expansion of real-world data (RWD) in regulatory decision-making, spurred on in the US by the 21st Century Cures Act, has caused a sea change in clinical trial design. More and more, researchers and organizations have shifted from the classic randomized clinical trial (RCT) design to newer models, like external control arm studies. A new Clinical Leader article by Debra E. Irwin and Ryan M. McKenna lays out the unique features of external control arm studies and how they can be implemented into clinical trials.
According to the authors, “In an external control arm study, enrolled patients receiving the intervention are compared to patients outside of the study.3 The external control arm could be patients who received treatment earlier (historical) or a group treated at the same time but in a different setting (contemporaneous). Because some external control arm studies use RWD that is already collected, it can be an efficient way to evaluate the impact of an intervention.”
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(Source: Clinical Leader, May 16th, 2022)