CFDA Addresses "80% of China Trials are Based on Fraudulent Data" Story

The CFDA officially announced the results of its year-long "Self-Examination" experiment, an initiative that required pharmas to verify the clinical trial data in their requests for drug marketing approvals. Fifteen months ago, the agency selected 1622 registration requests for the experiment. The pharmas were asked to attest that all clinical trial data in the submissions met standards for authenticity, integrity and compliance. Over time, 83% of the requests were withdrawn. Of the remainder, about half (117) have been examined, and 26% of them (30) were found to be deficient in some manner. More details.... Share this with colleagues: // //