All Times EDT
Keywords: cell, cellular, gene, immuno-oncology, CAR-T, TIL, challenges, therapy
After the design of the study, cellular and gene therapy studies bring new challenges in the implementation of clinical trials. How do statisticians interact in this space? This roundtable is about shared experiences and solutions during study conduct and reporting. Discussion topics will cover challenges and seek to find shared solutions in some of the following areas:
(1) Case report form development to capture complexities of adverse events of special interest (e.g. neurotoxicities, signs and symptoms and multiple grading scales) and other data unique to these studies that are necessary for statistical analysis
(2) Pain points in statistical analysis plans such as date imputations, censoring rules, estimands and intercurrent events, analysis populations, potentially important laboratory thresholds and other definitions
(3) Considerations in data and reporting for dose escalation meetings, data monitoring committees and interim analyses
(4) Issues during statistical analysis and successful solutions.