Our Statistical Consulting and Data Science teams offer in-depth expertise on the implementation of external/synthetic control arms for clinical studies where there may be operational constraints on patient populations.
Synthetic control arms enable data from external sources to be used to enrich the population of a study. Sources for this can include real-world data from electronic health records, health insurance claims, fitness trackers, disease registries, and historical and clinical trial data. Successful integration of external data requires early statistical input when designing and analysing studies seeking to exploit these strategies. To address common issues, the FDA has published a draft guidance for the design and conduct of externally controlled trials.