Plus Therapeutics Inc (NASDAQ: PSTV) and Medidata have expanded their partnership to increase patient recruitment, enhance their access to the therapy, and lower the costs of the study Rhenium-186 NanoLiposome. This therapy is to treat recurrent glioblastoma.
The parties will use the Synthetic control arm from Medidata
The collaboration will leverage the Synthetic Control Arm of Medidata. This platform will enable the companies to use data from past clinical trials in a way approved by the FDA. The companies decided on the partnerships after evaluating their potential for success and the project’s feasibility.
According to the Senior Vice President and CMO of Plus Therapeutics, Dr. Norman LaFrance, the synthetic control arm of Medidata will cut down on the cost and time that comes with trials for rare diseases like glioblastoma.
Dr. LaFrance adds that the company was satisfied with Medidata’s platform, capabilities, and the team as it evaluated the project’s feasibility. Furthermore, the partnership will allow the companies to expose fewer volunteers to placebos and other ineffective treatments, thus potentially extending their lives.
Medidata will give Plus Therapeutics a synthetic control arm that the matter will add to its Phase II trial. This move could help many patients who find the standard care for glioblastoma ineffective.
The synthetic control arm is an external control that Medidata forms by choosing patients from its file on clinical trials. The company does this to allow matching of the disease and demographic characteristics of patients it treats with the trial drug.
The synthetic control arms limit the number of placebos
Many researchers agree that synthesis control arms could accurately mimic classic randomized controls. For this reason, they are accurate in interpreting the efficacy of the therapy under investigation
Furthermore, synthetic control arms could improve the validity of trials. In other cases, they could reduce the need to expose many patients to placebos or ineffective treatment standards, thus benefiting more people if the therapy is effective. Despite this move, the result is still highly valid and accurate.
As a result, studies that use synthetic control arms to do a better job of convincing patients to participate. The involvement is even higher in patients with a poor prognosis of few alternatives for treatment.
Plus Therapeutics hopes this study could help fulfill its goal to develop therapies for patients with fatal diseases.