Health1 min read

STAT+: In China, a flood of controversial clinical trials slows to a trickle

By · Via STAT Health · Published by Everything Blog

In short

Central authorities initiated the crackdown to rein in a mechanism that previously let researchers conduct human trials without central regulatory approval. This shift aims to prevent further patient harm, but it has directly halted emerging research initiatives across the country. For example, the Hope for Rare Foundation saw two planned clinical trials stopped this past summer despite significant diagnostic advances in domestic medical centers.

Key points

  • Chinese regulators moved to restrict human testing pathways after patient deaths sparked…: Chinese regulators moved to restrict human testing pathways after patient deaths sparked increased government scrutiny.
  • Stricter oversight disrupts the development of experimental treatments targeting underser…: Stricter oversight disrupts the development of experimental treatments targeting underserved rare genetic conditions.
  • The sudden policy shift closes a regulatory loophole that once gave Chinese drug develope…: The sudden policy shift closes a regulatory loophole that once gave Chinese drug developers a major speed advantage.

Sources checked by our analysis pipeline: 1

SHANGHAI — Juan Huang noticed her 13-year-old daughter, Huangxi, was leaning out of her stroller, so she undid the buckles, scooped her out, and laid the length of her — long, loose, rail thin — across her lap.

In 2014, doctors here had no answers for why 16-month-old Huangxi suddenly couldn’t stand or walk anymore. It took two years and a flight to Massachusetts to diagnose a genetic disease never identified in China, and even the Boston Children’s Hospital doctors couldn’t offer any treatments.

But much has changed in the decade since. Chinese hospitals became sophisticated centers for diagnosing and treating rare disease. And a foundation Huang works for helped push genetic treatments into trials, at a fraction of the cost in the U.S. It was on track to start two more trials — until this summer, when deaths, news reports, and new government rules upended those plans.

The government has become “very strict,” she said, as she stroked Huangxi’s back on a bench on the banks of the Huangpu River.

Huang, who worked as an engineer before her daughter’s…

Health