Cross-study safety analysis of risk factors in CAR T cell clinical trials: An FDA database pilot project

Predictive models for response and survival in patients treated with anti-PD-1 monotherapy or with anti-PD-1 and ipilimumab combination: editorial commentary

“…The findings also need to be replicated by independent centers in larger cohorts to gain wide application in tertiary centers. Recently researchers from FDA published a cross-study analyses of risk factors in chimeric antigen receptor T cells (CAR-T cells) based on voluntarily submitted sponsor data across 17 phase 1 and 2 studies in 1,926 patients through a FDA database pilot project ( 18 ). Similar initiative can be extended to rich data submitted for PD-1 blockers and combinations to externally validate the findings from this study.…”