Using Real-World Data to Implement External Comparator Arm Studies

Single-arm trials (SATs) have entered the clinical trial space thanks to the growing abundance of real-world data (RWD) from sources like electronic health records (HER) that allows for the use of external comparator arms (ECAs). These trial formats help accelerate and enable research, especially when randomized controlled trials are infeasible. In a new article on PharmaPhorum, Dr. Gerd Rippin of IQVIA discusses the use of RWD in SATs.

According to Rippin, “As with any research study, sample size plays a critical role in ensuring the study results can be used as valid evidence for treatment efficacy and safety. When it comes to sample size for ECAs, there are several unique considerations, including whether data for one treatment arm is already available, whether additional conservativeness should be incorporated when estimating needed sample sizes, and how to incorporate the usage of causal inference methods.”

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(Source: PharmaPhorum, October 11^th, 2022)