Data of drug clinical trials will be subject to "third party inspection"

October 24, 2013 source: the clinical trial of drugs in science and Technology Daily is an important gateway to test the safety and effectiveness of drugs The authenticity of clinical trial data is vital, especially important Some new drugs from research and development to drug marketing often need to invest a lot of money If we do not grasp the important gateway of clinical trials, clinical data distortion, often lead to poor efficacy after marketing, greatly reduce drug sales, or even delisting How can we improve the quality of clinical trials? What are the links involved? The reporter interviewed insiders on relevant issues If the clinical trial data is not internationally recognized, the new drug will go through many links, such as research and development, clinical trial and approval Drug clinical trial is an important step to test drug safety and effectiveness China has sound laws and regulations on drug clinical trials, and has issued regulations and relevant guiding principles such as measures for the qualification of drug clinical trial institutions (for Trial Implementation), measures for the administration of drug registration, guidelines for the ethical review of drug clinical trials, guidelines for the administration of biological sample analysis laboratories in drug clinical trials (for Trial Implementation) The current GCP in China comes from the international standard ICH GCP jointly sponsored by Europe, the United States and Japan, which is basically consistent in the basic principles and most of the implementation rules However, China pays attention to strengthening the centralized control of the right of approval and management of clinical research, that is, the approval of research requires higher system It is reasonable to say that this system is relatively complete If all parties fulfill their respective responsibilities, it is more rigorous and standardized But the reality is that the data of clinical trials in China are not widely recognized in the world, and the quality of clinical trials is not satisfactory In 2012, the former State Food and Drug Administration inspected 134 drug clinical trial institutions, 38 of which need to be rectified, accounting for 28.5% of the total Among them, 23 of the more serious problems are followed up by the State Bureau, and the other 15 are followed up by the Provincial Bureau Why is the clinical trial data distorted? China has strict drug clinical trial specifications and access procedures, but the data of drug clinical trials in China is distorted Why did this happen? What should be done to ensure the authenticity and reliability of clinical trial data? Cai xuliu, general manager of Beijing Jingwei legend company, told reporters, "under strict laws and regulations, the implementation process has been discounted Compared with the United States, China's drug review centers have fewer personnel, more review items, and the clinical research links cannot be effectively connected, and the "data" that can be relied on is limited, which leads to the difference between China's drug review mechanism and the United States China's drug review is barrel shaped, and the basic drugs that can be imported can be exported, while the FDA's drug review in the United States is funnel-shaped, wide imported and strict exported, and the FDA in the United States New drugs are strictly controlled before they are put on the market There are many inferences in the clinical trial data of our country, resulting in partial distortion " For a new drug clinical research, even if the scheme design is perfect and the test results are beautiful, if there are problems in the research process, all the data are meaningless Li Youxin, vice president of R & D of green leaf Pharmaceutical Group, told reporters that in the United States, a drug often needs to do several or even dozens of phase II and phase III clinical trials before it is put on the market to test the safety and effectiveness of drugs in different situations In China, only one phase II and phase III clinical trial is put on the market, and enterprises rarely take the initiative to design multiple clinical trials according to different conditions of patients 。
In recent two years, green leaf pharmaceutical has applied for FDA certification of several drugs in the United States, and some drugs are doing clinical trials in the United States and China at the same time "Only when the clinical trial data is reliable can enterprises rest assured," Zhang Peipei, director of the drug evaluation center, said on October 22 that "innovation, safety and responsibility" At the first symposium on clinical research quality (process control), it was said that if such a conference had been held a few years ago, there would not have been so many entrepreneurs interested in the truth of clinical trial data, but today, this topic has attracted so much discussion and attention, which shows that our pharmaceutical companies attach importance to innovation and are making progress " The research of evidence-based medicine is based on the data of clinical trials If the data of clinical trials are not true, science may only be a castle in the air It is urgent to implement the quality management of clinical research process, improve the level of clinical trials of Chinese drugs and strengthen the authenticity of clinical data According to the analysis of the insiders, the root cause of the distortion of clinical trial data is not that the pharmaceutical factory is eager for success, not that cro is not responsible, not that the doctors are too busy to learn GCP, the main reason is that the chain is loose, lack of supervision, and the ultimate reason is that the responsible person of each chain is "irresponsible" The lack of supervision in the clinical research process of the third-party inspection company will stop the investment of new drugs, blind promotion of pharmaceutical enterprises, make the evaluation center "without evidence", and make Chinese pharmaceutical science become worthless garbage In order to improve the quality of drug clinical trials in China, on the one hand, we should strive to build a high-level team of researchers who are full of innovation awareness, familiar with international development trends and master the domestic and foreign regulatory requirements, strengthen the system construction, strengthen the hardware construction of clinical trial institutions, and vigorously support and promote the innovation of national medicine On the other hand, we should innovate the regulatory mechanism and comprehensively improve the regulatory level In September 2013, in order to strengthen the supervision and management of drug clinical trials, promote the openness and transparency of drug clinical trial information, and protect the rights and interests and safety of the subjects, the State Food and Drug Administration issued announcement No 28, requiring the registration and publicity of drug clinical trial information Drug clinical trial registration and information publicity records will be related to drug technical review and supervision and inspection Through the information platform, the public can query the public information of drug clinical trials in China, understand and promote the standardization of drug clinical trials, and play a role of social supervision At present, a third-party inspection company has appeared in China to supervise the clinical trials of new drugs "The" third party inspection "is equivalent to the role of" supervision "in the construction engineering When the test is started, the scheme is controlled, the researchers and the test team are trained, and the problems of the test are found in the test process After the problems are found, they are retrained to avoid the same problems in the future Its main business is to help the sponsor obtain real and comprehensive clinical trial data, and to assess and manage the risk of new drug investment It is reported that "third party inspection" starts from the basic level of clinical trials, that is, subjects and doctors, through on-site verification and analysis of basic level data records and statements, to find out problems and analyze problems, write inspection reports, and provide them to the sponsor (usually pharmaceutical factories or investors) As a "supervisor", the "third party inspection" seems to be playing a "special" role between the investor and CrO (contract research organization) Cai xuliu said that the market capacity of third-party inspection is very large According to the data on the website of the drug administration, there are more than 8400 new drugs approved for clinical trials at present, and 4000 new drugs may need to be examined for clinical trials and post marketing research Each new drug has about 700 cases, and the average cost of each new drug audit is about 400000, so the 4000 new drugs need 1.6 billion In addition, about 1000 new drugs are added every year, which also requires clinical trials and supervision The regulatory cost of these new drugs is about 500000 to 600000 projects, so the annual new market is about 500 to 600 million At present, there are few third-party inspection companies in the market With the emergence of investment risks and the increasingly standardized pharmaceutical market, the day of "third-party inspection" of new drugs may not be far away