Efficacy Endpoints in Phase II Clinical Trials for Meningioma: An Analysis of Recent Clinical Trials.

Shinya WatanabeTakahiro NonakaMakoto MaedaNarushi SugiiKoichi HashimotoShingo TakanoTomoyoshi KoyanagiMasanobu YamadaYoshihiro ArakawaEiichi Ishikawa

Published in: Therapeutic innovation & regulatory science (2023)

Time-to-event efficacy endpoints were often compared to historical data, and two-dimensional evaluation is more suitable than one-dimensional one. Accumulation of prognostic data is essential to standardize time-to-event efficacy endpoints. Considering the difficulty of setting design for phase II clinical studies targeting meningioma, evaluation might be done with multiple efficacy endpoints.

Keyphrases

phase ii
clinical trial
open label
phase iii
double blind
electronic health record
randomized controlled trial
big data
placebo controlled
study protocol
cancer therapy