New drug clinical data fraud, accountability list where-sorpack

Clinical data fraud, accountability list where in the usual review author although the relevant departments thorough investigation of clinical data for fraud, but fraud liability, did not meet the public’s expectations, on which enterprises, hospitals involved in fraud and knowledge. Earlier this month, a "80% new reported clinical data involving fake link layers fall behind supervision" has caused shock, according to the State Food and Drug Supervision Bureau official website data, as of January 21, 2016, because of clinical trial data is not true and complete and other issues, the application for drug registration shall be approved by the State Food and drug administration, pharmaceutical companies self-examination for withdrawal up to 1184, the proportion reached 81%. New drug clinical data fraud, means that once approved by the drug market, there is no guarantee of quality and safety. If the illness is unlucky, then the patients with poor drug efficacy more in name than in reality, as the last straw, it is undoubtedly a great tragedy. The director of this tragedy, there are pharmaceutical companies, third party inspection agencies, has a large hospital aura. But it is surprising that the new drug clinical data has been crazy for many years, a comprehensive list of accountability? This round of clinical trial data checking and verification as an example, so far, the public saw only 8 companies for unauthorized modification and concealed clinical data to be informed, more fraud enterprises have not yet surfaced, and the third party inspection agency fraud and well-known hospitals, the public did not know What’s the name?. In addition, according to the clinical data verification, the main focus is the application in drug or not, for so many years by fraud, all kinds of drugs listed in the sales, how to review afterwards and the responsibility, is not what happened. It can be said that although the relevant departments thorough investigation of clinical data for fraud, but fraud liability, did not meet the public’s expectations. Of course, if you really go into full responsibility for fraud, it will set off at seas throughout the medical community, the pharmaceutical enterprises will face big reshuffle, some well-known hospitals will bear the stigma, but if the fear of too much influence and afraid to strictly enforce the law, it will be soft on the counterfeiters, is the law of betrayal, contempt the patients of the right to life. Therefore, clinical data fraud, must be responsible for the public. No matter how much the number of fake companies, fake hospital has a high social reputation, fraud problem how far, should be a check in the end to thunder trend. As soon as possible to the public to come up with a new drug clinical data fraud accountability list, which is the responsibility of the regulatory authorities can not shirk. Of course, from the spread of new drug clinical data fraud phenomenon, we can also see the drawbacks of the relevant regulatory mechanisms. For example, the cost of fraud is too low. However, in accordance with the regulations, the corresponding treatment is no longer accepted within 3 years of the application for registration of drugs, the person directly responsible for participating in the study or organization of clinical trial data will not be accepted within ten years. In foreign countries, related processing much more severe, pharmaceutical companies, R & D personnel, the doctor will be blacklisted, not only will face huge fines, cancel the occupation qualification punishment, or even criminal responsibility. Again, the clinical data of new drugs are considered "commercial secrets and technical secrets, not open to the public, people want to know the information of drug clinical trials is very difficult, the whole]相关的主题文章: