Guest Column | June 04, 2025
Everything To Know About Long-Term Data Collection For Cell And Gene Therapy Trials In The EU
By Jessica Cordes, senior consultant, Clinical Excellence GmbH
Cell and gene therapy (CGT) trials have opened transformative pathways for treating hematologic malignancies and other severe conditions. CAR-T, in particular, has rapidly progressed from early-phase trials to regulatory approvals and commercial use. Yet, while their short-term efficacy is often dramatic, their long-term safety and durability of response must be systematically monitored. The operational implications of this are significant.
Please read the full Clinical Leader Article.