General Administration of Food and Drug Administration: to strictly investigate the data fabrication of clinical trials in registration applications

BEIJING, April 10 (Xinhua) according to the website of the State Administration of Food and Drug Administration, the General Office of the State Administration of Food and Drug Administration once again publicly solicited opinions on the announcement (revised draft) on the handling of problems related to the verification of drug clinical trial data. In the first revision process, we insisted on seriously investigating and punishing the clinical trial data fabrication in the registration application in accordance with the requirements of laws and regulations. At the same time, we should give remedial measures if the judgment is not affected by subjective intention or other objective circumstances.

The State Administration of supervise and management on food and drug drafted the announcement on handling opinions on issues related to the verification of drug clinical trial data (draft for comments), and first publicly solicited opinions from the public from August 19 to September 18, 2016, A total of 280 feedback opinions were received from pharmaceutical enterprises, medical institutions, contract research organizations, industry associations and other units and individuals. The State Administration of supervise and management on food and drug revised it with feedback.

In the process of revision, the State Administration of supervise and management on food and drug insisted on clarifying the policy boundaries in accordance with the requirements of laws and regulations, and seriously investigated and dealt with the clinical trial data fabrication in the registration application; At the same time, starting from reality, if the difference is not subjective or intentional and other objective circumstances affect the judgment, remedial measures shall be given. Reasonable opinions and suggestions have been adopted, and there are six main conclusions:

I. For data fabrication of behaviors, serious adverse events that may be related to clinical trial medication and combined drugs that are prohibited by the missed trial protocol are not included.

II. For the varieties involved in drug clinical trials data fabrication applicants during the punishment period, if they are in urgent clinical need, they can submit special applications, the State Administration of supervise and management on food and drug organizes experts to make a decision on whether to accept or not.

3. For the drug clinical trial institutions involved in data fabrication, the clinical trial institutions shall be adjusted within a time limit to the professional rectification within a time limit.

IV. For the main researchers involved in data fabrication, all accepted registration applications will be adjusted from disapproval to suspension of review and approval.

V. For the varieties involved in data fabrication, clarify the procedures for handling relevant personnel, and adjust the contents published to the public and blacklisted.

VI. For handling and party review, increase and clarify specific procedures and approaches.

There are three suggestions that have not been adopted:

I. It is recommended to deal with it according to the proportion of data fabrication found, and no administrative penalty will be imposed when the proportion is relatively small. The provisions of laws and regulations are based on the nature of the illegal act itself, and the specific quantity is the plot problem. The verification process of drug clinical trial data of the State Administration of supervise and management on food and drug was terminated after data fabrication. Under the condition that the verification of all drug clinical trial data is not completed, the authenticity of other data cannot be guaranteed. The legal basis is insufficient to deal with the problem with the proportion of data fabrication found. This opinion was not adopted.

II. It is recommended to punish only data fabrication of clinical testing machines and researchers, and not the applicants. According to laws and regulations, the applicant proposes drug registration and bears corresponding legal responsibilities. The applicant is the principal and beneficiary of drug clinical trials, and must ensure that the clinical trial data in the registration application is true, complete and standardized, and is the subject of relevant legal liability. This opinion was not adopted.

3. It is recommended that the blacklist do not include specific inspector information. Establishing a blacklist system, concretizing the list, strengthening the accountability of specific inspectors and making it public to the public is an effective implementation measure to promote the applicant’s responsibility for supervising the implementation of drug clinical trial projects. This opinion was not adopted.

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zhongxin.com, April 10 (Xinhua) according to the information on the website of the State Food and Drug Administration, the General Office of the State Food and Drug Administration once again publicly solicits opinions on the announcement (revised draft) on handling problems related to the verification of drug clinical trial data. Modified for the first time