Medidata Blog
Medidata AI Highlights Work in Glioblastoma Clinical Trials at the Society for Neuro-Oncology Meeting
Glioblastoma (GBM) is the most common form of brain cancer in adults. Glioblastoma is extremely aggressive, with disease recurring in virtually all patients and a median survival rate of ~8 months following recurrence. The currently approved standard of care has not changed in over a decade, and eligible patients are recommended to seek treatment by entering a clinical trial.
In recurrent Glioblastoma, many trial sponsors utilize a single-arm study design in order to maximize patient access to novel treatments. It’s difficult to interpret the results of single-arm trials without a comparator arm of patients treated with standard of care. In these cases, an external control arm (ECA) provides a data-driven, patient-centric approach to understanding the treatment effect observed in the single-arm study.
ReSPECT-GBM is an ongoing phase 1/2 investigational study in adult recurrent glioblastoma. Using patients enrolled into the first part of the study, this research determined that an ECA could be successfully created to align to the baseline characteristics of the ReSPECT-GBM study patients. Based on these findings, an ECA could provide an effective approach to more accurately interpret the results from the ongoing phase 2 ReSPECT-GBM study
Medidata AI is proud to present their research poster on the creation of an ECA in recurrent Glioblastoma and what it might mean for the future of better understanding early-phase clinical trials at the Society for Neuro-Oncology Meeting on November 15th-19th in Vancouver, Canada.
Norman LaFrance
Chief Medical Officer, SVP
Plus Therapeutics
Lisa Ensign, PhD
VP, Data Science
Medidata AI
Authors: Lisa Ensign*, Norman LaFrance†, Lihong Diao*, Denis Boisvert*, Joel Michalek ‡, Andrew Brenner‡ , Melissa Moore†, Marc Hedrick†,Ruthanna Davi*
*Medidata AI, †PLUS Therapeutics, ‡University of Texas San Antonio Mays Cancer Center