Value of central review of RECIST v1.1 outcomes in the AGITG INTEGRATE randomised phase 2 international trial for advanced oesophago-gastric cancer.

Katrin M SjoquistAndrew MartinNick PavlakisDavid GoldsteinEric TsobanisDaniel MosesRichard MaherWendy HagueVal GebskiMartin R StocklerR John Simesnull null

Published in: Journal of cancer research and clinical oncology (2022)

Blinded independent central review was feasible and supported the reliability of site assessments, trial results, and conclusions. Modelling showed that when treatment effects were large and outcome assessments blinded, central review was unlikely to affect conclusions.

Keyphrases

study protocol
clinical trial
phase iii
placebo controlled
phase ii
randomized controlled trial
open label
double blind
type diabetes
metabolic syndrome
insulin resistance