Comment ｜ A large amount of data in new drug trials is suspected of fraud？ Don’t trifle with drug safety.

　　CCTV News:In the process of medical clinical experiments, in order to observe the safety and metabolic process of drugs, it is necessary to test drugs on healthy people, and professional drug testers came into being. Recently, a survey on "Drug Testers Pass the Physical Examination by Controlled Intermediary" said that every link of subjects, intermediaries and pharmaceutical companies "may be counterfeiters".

△ On October 31st, an intermediary was recruited in a 3A hospital in Beijing to check the subjects’ ID cards. (Photo/Beijing News)

　　"Drug Testers Pass Physical Examination by Controlled Intermediary"(Excerpt from the report)

　　Drug testers muddle through the physical examination

　　It is not uncommon for the subjects to cheat in clinical trials of drugs, especially to get away with it in physical examination.

　　Various methods of muddle through are popular among the subjects: smokers want to pass the urine test, and they can drop one or two drops of white vinegar during the urine test; Use 10 times the dosage of bifendate to deal with the drinking problem, so that transaminase will become normal; For another example, you can get away with it in another hospital by applying some liquid foundation to the needle holes of your arms. Some subjects swallowed the medicine in front of the doctor and then spit it out after leaving the doctor’s sight.

　　The clinical examination of drug testing goes through the motions

　　Screening subjects require a 5-day interval, that is, they cannot participate in the next hospital screening … … On December 7th, the reporter went to Beijing No.1, No.3 and No.3 Hospital for a medical examination. Because he registered for a medical examination in another hospital on the 6th, it was still in the interval when checking his ID card. After a simple inquiry, the nurse indicated that the interval could be changed. After simple operation, the reporter’s ID card passed the hospital system and he can continue the medical examination.

△ On November 3rd, in a major hospital in Beijing, the doctor screened the eye of the needle for the subjects during the physical examination of drug testing. (Photo/Beijing News)

　　In addition, in order to let a subject whose body mass index exceeded the standard pass the screening, the hospital nurse took her to measure her weight on several high-weight machines several times, until the data on the machines met the standard, and then printed the results.

　　The efficacy and safety of drugs mainly depend on clinical trial data. However, it is doubtful whether the clinical data provided by drug testers in the report can be true and effective and become qualified clinical trial data of new drugs.

　　Nearly 70% of clinical trial data of new drugs are untrue and incomplete.

　　At present, the hospital or relevant departments have not expressed their views on this survey from the media. However, since last year, china food and drug administration has checked the clinical trial data of some drugs that have been declared to be produced or imported for trial, and also found some problems.

　　According to the data of official website of the State Food and Drug Administration, as of March 1, 2016, due to the untrue and incomplete clinical trial data, the number of drug registration applications rejected by the State Food and Drug Administration and withdrawn by pharmaceutical companies for self-examination was as high as 1,184, accounting for 73% of the total number required for self-examination. If 165 clinical exemptions are deducted, the proportion is as high as 80%. According to a survey conducted by China Journal of Clinical Pharmacology in 2013 on domestic experimental institutions, the rate of irregular experimental records was 85. 7%.

　　Cctv review

　　New drug trial data fraud, must be zero tolerance!

　　It has been some time since the falsification of drug clinical trial data was exposed. This is by no means a "cold" that can heal itself, but a serious illness that must be treated as soon as possible.

　　Do not forget your initiative mind, an effective producer supervisor to ensure drug safety.

　　It is the common expectation of all patients to get rid of the disease, and a true, standardized and complete clinical trial is the source guarantee of drug safety and effectiveness. Once the clinical fraud, the drug is "three-point poison" without listing. Historically, there have been many new drugs that have been put into production quickly without strict clinical trials, such as the use of penicillin. But that was forced by the situation. It was another kind of conscience to actively put into production in World War II just to seize life against time. Today, there is no such space-time environment. Today’s drug conscience is the most scientific and serious attitude. As Bi Jingquan, director of the State Food and Drug Administration, wrote, "Neither producers nor regulators can forget the initial intention of ensuring the safety and effectiveness of drugs."　

　　The chain of links is out of control, making fake data an opportunity.

　　In the article, Bi Jingquan also mentioned that "for the problem of data fraud, we must use ‘ Zero tolerance ’ Attitude. " New drug trials can be done by one party alone, and it is often not the responsibility of one party to get away with data fraud. The reason is often because of the chain out of control from pharmaceutical companies to clinical trial contract organizations (CRO), from researchers in clinical trial institutions to regulatory authorities. On the road of new drug testing, pharmaceutical companies are desperately in a hurry, the experimenter helps to open the "green light", and the regulator does not issue a ticket in time, which leads to such a result.　

　

△ data map

　　Prolonging life and saving life need to ask drugs for curative effect, and curative effect is the "life" of drugs. Once the hidden rules of fabricating data, tampering with data and concealing data become popular, the medical ethics that takes life seriously will have nowhere to go. The script should not be taken like this. If the pharmaceutical company as the applicant can strictly fulfill its supervisory responsibilities in accordance with the Good Practice for Clinical Trial Quality (GCP); If the clinical trial contract organization (CRO) entrusted by the applicant is not blinded by interests; If clinical trial researchers can not forget the awe of doctors, if clinical trial institutions check the research results, and if some drug regulatory authorities do not become a mere formality in on-site inspection of clinical trials … … If these were established one after another, there would be no such problem.　

　　Four "most" should be implemented in safety supervision

　　There have been too many lessons in the field of food and medicine. The lesson of melamine has just passed, and the Shandong vaccine case has hit the confidence of the whole society by half. Undeniably, in the field of drug research and development, China is still a latecomer in the catch-up stage, but this does not constitute the reason of "wanting money but not dying" and "picking up sesame seeds and losing watermelon". Therefore, Wang Yang, Vice Premier of the State Council, put forward four "most important" points when he visited the State Food and Drug Administration this year: to implement the most stringent standards, the most stringent supervision, the most severe punishment and the most serious accountability.

　　As far as drug clinical trials are concerned, the premise of strict responsibility is to clarify responsibility. Theoretically, the applicant for drug listing bears full legal responsibility for the registration data, while the project researcher and clinical trial contract organization (CRO) of drug clinical trial institutions bear direct responsibility for the authenticity and integrity of the data, while the drug clinical trial institutions are indirectly responsible.

　　However, in practice, the supervision of clinical trial institutions and contract research organizations (CRO) is still loose, and there are almost no hospital institutions and contract research organizations (CRO) that have been publicly dealt with because of data fraud in clinical trials. This state must be reversed as soon as possible.

　

△ data map

　　Of course, to solve the problem, it is necessary to sort out the source. The data of new drug trials is fraudulent, on the one hand, it is negligent in supervision, on the other hand, it is tired of testing. Because in addition to active fraud, there is indeed a phenomenon that clinical trial institutions are "overwhelmed", which leads to irregular trials. Therefore, it is necessary to achieve the matching between the regulatory capacity and the regulatory object, and also to achieve the matching between the drug clinical trial institutions and the market demand. To solve this problem, it is necessary not only to simplify the examination and approval procedures of new drug clinical trials, but also to attract more medical scientists to participate in drug clinical scientific research. Let clinical research develop as a science and technology industry, and it is also a direction to prevent the falsification of drug test data.

　　Wen Yi, the Mountain of Special Contributions for CCTV Comments