Response to MC Chamberlain: Convection-enhanced delivery of transforming growth factor-02 inhibitor trabedersen for recurrent high-grade gliomas: efficacy real or imagined?,in reference to W Wick and M Weller:Trabedersen to target transforming growth factor-p: when the journey is not the reward, in reference to Bogdahn et al.(Neuro-Oncology 2011 ;13:132 -142)

摘要

We thank Dr. Chamberlain and Drs. Wick and Weller for their careful evaluation of our publication~1 and their thoughtful comments. We would like to take the opportunity to respond to their comments to this randomized and controlled phase lib trabedersen study. Traditionally, drug development in oncology has been based on single-arm historically controlled phase II studies. To avoid the pitfalls associated with a single-arm design for phase II studies, randomization and a prospective control arm have been recommended to generate hypotheses that are to be confirmed in subsequent phase III studies.~(2'3) We therefore designed the trabedersen study in high-grade glioma as a randomized and active-controlled phase lib study with high-quality standards, including central histopathology and central MRI reading.