Influence of an independent review committee on assessment of response rate and progression-free survival in phase III clinical trials

BACKGROUND: Our objective was to determine the variability in assessment between investigators (INV) and independent review committees (IRC) for response rate (RR) and progression-free survival (PFS). METHODS: Phase III trials reporting INV and IRC assessments were identified. The difference in end point assessment (IRC - INV) across all study arms was determined. A random-effects model was used to calculate the mean difference between INV and …