Clinical Trial Design for Cellular and Gene Therapy

Introduction of Early-Phase Trials For Cell and Gene Therapy
All Early-Phase trials are conducted under the IND regulations in 21 CFR Part 312 which emphasize the importance of the assessment of trial risks and the safeguards for trial subjects. For early-phase clinical trials, especially first-in-human trials, the primary objective should be an evaluation of safety (21 CFR 312.21). The FDA has issued guidance on "Consideration for the design of early-phase clinical trials of cellular and Gene Therapy Products." 


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