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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