An official from the Department of Drug and Cosmetics Registration of CFDA was interviewed about “the issues on authenticity of clinical trial data in new drug registration applications” reported by media.
The official introduced that according to the Announcement on Performing Self-Examination & Verification of Drug Clinical Trial Data issued on July 22, 2015 by CFDA, for 1622 registration applications for marketing and import, the applicants had been required to do self-examination on the authenticity, integrity and compliance of clinical trial data. Deducting 193 registration applications exempted from clinical trial, the total number of applications for self-examination was 1429. Applicants could voluntarily withdraw their registration applications with problematic clinical trial and reapply after supplementing their dossiers. By the end of June, 2016, 1193 voluntary withdrawals happened after self-examination of the companies, accounting for 83% of the total number of registration applications for self-examination.
Since October, 2015, CFDA has organized the verification on registration applications under review. 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.
He emphasized that, there were many reasons for the companies voluntarily withdrawing their applications after self-examination. Some were for nonconformance to the Good Clinical Practices, which could affect the scientificalness and accuracy of the clinical trial results; some were for data incompleteness, which could not be traced back, and were insufficient to demonstrate the safety and effectiveness for the drug in application; some were for untruthful data, part of which cannot be excluded of the possibility of deliberate data fraud. Thus, it cannot simply attribute the companies’ voluntary withdrawal to data fraud. Therefore, the reports that “80% of China’s clinical trial data are fraudulent” by some media are not fact based.
He pointed out that the drug R&D process is a very costly and time consuming process which needs hard work and arduous input by scientists and medical professionals. The success marketing of every innovative drug marks a new step forward in fighting against disease for human beings and is the result of the contributions of unnamed scientists. For example, TU Youyou, the famous Chinese Scientist and Nobel laureate for discovering artemisinin, is an outstanding representative of such group. However, the drug R&D must be conducted scientifically and rigorously, in which no dishonesty is allowed, let alone deliberate fraud. The initiation on the self-examination and verification of clinical data and cracking down on data fraud aims at encouraging innovation and creating a favorable environment for fair competition in order to ensure the safety and effectiveness of the drug approved to the market.
He said the whole process of the self-examination and verification of drug clinical trial data is transparent and open. Since July 22, 2015, 21 announcements have been issued by CFDA, informing the public of the related work progress. Everybody interested in that is welcome to visit the websites of CFDA and the Center for Food and Drug Inspection of CFDA.