China Reins In Cancer Drug Trials, Stressing Patient Needs and Benefits

Tougher Comparator Requirements

China's drug regulatory authority is taking aim at strengthening randomized, controlled clinical trials conducted domestically for cancer drugs, leaving biotech stocks reeling from the proposed stricter requirements.

clinical trial progress
China’s CDE stipulates clinical value is determined by whether clinical needs can be met to maximize patients’ benefits • Source: Alamy

China’s Center for Drug Evaluation (CDE) is taking steps to rein in the nation’s exploding anticancer drug clinical trials, with a draft document that would require sponsors to conduct randomized controlled studies using best-in-class existing therapies as comparators, where these are available.

When choosing control drugs for such trials, the main focus should be on whether the study products represent the best...

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