DASTY - Plus Therapeutics Medidata team up for synthetic control arm solution in trial

Plus Therapeutics (PSTV) is collaborating with Medidata, a unit of Dassault Systèmes (OTCPK:DASTY), to evaluate the use of its Synthetic Control Arm (SCA) solution in a planned phase 2 trial of Rhenium-186 NanoLiposome in recurrent glioblastoma, a type of brain cancer. The company said SCA is formed by selecting patients from Medidata’s repository of historical clinical trials to match the baseline demographic and disease characteristics of the patients treated with the new investigational product. Plus Therapeutics said SCA enables study designs that have a higher than usual probability of assignment of prospective patients to the investigational therapy. This enhances patient enrollment and potentially reduces trial costs. “Medidata has developed a pioneering capability and helped to validate the use of synthetic controls in clinical drug development,” said Norman LaFrance, chief medical officer and SVP at Plus Therapeutics.

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Plus Therapeutics, Medidata team up for synthetic control arm solution in trial