Girl dies after experimental gene-editing trial in China

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A young girl died after receiving an experimental gene-editing treatment in an investigator-initiated clinical trial in China, the article reports. The case highlights that some trials are reviewed only at the local level, allowing researchers to test novel therapies without approval from the national drug regulator. The incident underscores opaque oversight in certain investigator-initiated studies and could prompt scrutiny of local review practices, possible regulatory reviews, and calls for clearer rules on safety and approval for experimental gene-editing therapies.

Investigator-initiated trials in China can proceed without national approval