For years, U.S. scientists and biotech companies have watched warily as China has made strides onto the global stage, overtaking them in research spending, patent applications, and clinical trials.
To many observers, it has been a sign that the U.S. needs to urgently modernize a lumbering clinical trial and regulatory system. But now, a key driver of China’s roaring biomedical engine — one that many researchers believe the U.S. should replicate — is being fine-tuned, and a system that was credited with supporting the country’s wild success has come under scrutiny.
That system has been fueled by what are known as investigator-initiated trials, or ITTs, in which researchers were long permitted to launch clinical trials without sign-off from the National Medical Products Administration, China’s equivalent of the Food and Drug Administration, and without the rigorous review that would otherwise come with it. The studies have allowed China to speed up the translation of medical research, encourage physicians to become a part of the country’s drug innovation engine, and help produce billions of dollars in sales of newly approved medicines.
They also appear to have come at a price, raising questions about patient safety, a lack of transparency, and the use of intellectual property.
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