Plus Therapeutics, Inc. announced a partnership with Medidata, a Dassault Systèmes company, to evaluate the use of its Synthetic Control Arm solution in a planned Phase 2 trial of Rhenium-186 NanoLiposome in recurrent glioblastoma, a type of brain cancer. SCAs are especially advantageous in indications such as recurrent GBM where the standard of care control treatment is considered undesirable by some patients and physicians. The 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 retention and potentially reduces clinical trial costs while upholding the scientific integrity of the trial. Synthetic control arm – a type of external control – is formed by carefully selecting patients from Medidata's extensive repository of historical clinical trials to match the baseline demographic and disease characteristics of the patients treated with the new investigational product. Case studies have shown that SCAs can effectively mimic a classic randomized control and, therefore, can be used to accurately interpret the treatment effects of an investigational product.

SCAs can help enhance the scientific validity of single-arm trials and, in certain indications, enhance randomized clinical trials to expose fewer prospective patients to control and/or ineffective or existing standard-of-care treatments that might not provide a benefit to the patient. This is done while still providing highly valid scientific evidence. These factors can influence a patient's willingness to participate in a trial where there is a very poor prognosis and perceived inadequate standard of care.