China: Fraud not the only reason 1,193 drug applications were withdrawn; Advaxis shares drop
Just how much fraud is involved in clinical trials in China? Some recent reports suggested that the rate is 83%, but Chinese officials beg to differ. While it’s true that 1,193 applications have been withdrawn following a period of self-examination — out of 1,429 that were put under the spotlight — the government notes that there are plenty of reasons besides fraud for a withdrawal. Why, some just had incomplete or insufficient data on safety and efficacy, which didn’t necessarily rely on fraud. And there were some for “untruthful data,” which could include fraud. The CFDA concludes: “By the end of September, 2016, 117 registration applications have been verified, 30 of which were rejected due to defects with authenticity, accounting for about 2% of the total number of registration applications for self-examination and verification. 27 applications, as well as 11 clinical trial institutions and the CROs suspected of providing fraudulent data have been investigated.”
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