Glioblastoma Multiforme: Medidata AI's Synthetic Control Arm

Medidata AI’s Synthetic Control Arm^® (SCA^®) leverages historical clinical trial data (HCTD) to provide a more relevant clinical insight for the purpose of developing new therapies. In comparison to RWD, HCTD based SCAs utilize “regulatory grade” data, comprised of traditional clinical trial style endpoints and complete covariate information, as they were designed in the clinical protocol, and captured, monitored and validated in the Medidata Rave electronic data capture (EDC) platform. HCTD enables data-driven decision making by providing patient-level data in the common domains and over 100 harmonized variables.

Medidata AI SCA has helped sponsors who wish to compare patient outcomes of their novel therapies to patient outcomes associated with standard of care therapies to enhance single arm phase II trials and accelerated approval submissions or as part of confirmatory phase III trials.