Clinical Trials on Cell & Gene Therapy
Clinical Trials of Cell and Gene Therapy products often varying from the clinical trials design for other types of pharmaceutical products. These differences in trial design are necessitated by the distinctive features of these products. The clinical trials also reflect previous clinical experience and evidence of medicine. Early experiences with Cell and Gene Therapy products indicate that some CGT products may pose substantial risks to subjects due to effect at cellular and genetic level. The design of early-phase clinical trials of Cell and Gene Therapy products often involves the following consideration of clinical safety issues, preclinical issues, and chemistry, manufacturing and controls (CMC) issues that are encountered.