Three deaths in China shake trust in the country's speedy clinical trial system

China’s cheap, fast and quiet system for testing cutting-edge medicines is facing scrutiny after the deaths of three people in investigator-initiated trials.

The studies, also known as IITs, allow experimental cell and gene therapies to be tested without oversight from China’s national drug regulators and have become the envy of many US biotech leaders. Now three groups vying to be the first to successfully pioneer a cure for autoimmune disease and new applications of CRISPR gene editing have seen their work lead to tragedy.

“I was sad but not at all surprised,” said Kiran Musunuru, a gene editing scientist at the University of Pennsylvania who knew early on about the two ill-fated CRISPR gene therapy trials — one for children with a neurological condition and the other for those with a fatal muscle disease. “I remember vividly thinking this isn’t going to end well. It had all the makings of a disaster.”

The deaths have become a flashpoint for several ongoing debates, including the transparency and trustworthiness of drug development in China and the wisdom of the country’s lenient IIT...