Clinical trial data not internationally recognized will be subject to "third party audit"

The clinical trial of drugs 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 the insiders on relevant issues The clinical trial data of our country is not recognized by the developed countries With the continuous development of modern science and technology, China's medical and health undertakings have made great progress, and the medical level is becoming more and more advanced In front of the disease, people gradually eliminate the previous fear, but on the way of development in exploration, some problems will inevitably be encountered The marketing of new drugs should go through many links, such as research and development, clinical trials 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     After the new drugs invested heavily in R & D by pharmaceutical companies are put on the market, their efficacy is not as good as expected, and there are hidden dangers in safety What are the reasons? Why are the clinical trial data in China not recognized by developed countries? Recently, in the "innovation? Safety? Responsibility" first clinical research quality (process control) academic seminar and "clinical research quality and risk assessment" sponsored by China Pharmaceutical Quality Management Association On the Preparatory Committee of the center, the relevant person in charge of the drug evaluation center of the State Food and Drug Administration analyzed and proposed this 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 Although the relevant laws and regulations are strict, the implementation link is discounted by different executors: the certification assessment is not strict, the base management is not in place, the researchers are too busy and unfamiliar with GCP (clinical trial specification), cro company (contract research organization) pursues profits, SMO company (base management organization) helps counterfeiting, and enterprises do not pay attention to it professionally All of these are the reasons for the poor quality of clinical trials in China 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 subjects, in September this year, the State Food and Drug Administration issued announcement No 28, requiring the registration and publicity of drug clinical trial information 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 team 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 It is mainly to help the sponsor to obtain real and comprehensive clinical trial data, and to assess and manage the risk of new drug investment As a "supervisor", the "third party inspection" seems to be playing a "special" role between the investor and CrO (contract research organization)     Medicine is a "magic product" for people, which can save human health, but at the same time, there are many drawbacks in the pharmaceutical industry, which have brought great influence to people For example, in the past decades, the pharmaceutical industry has repeatedly concealed and lied about the data obtained in clinical trials, resulting in a large number of widely used drugs in various fields Exaggeration, which is endangering people's lives and wasting public resources, is a distortion of science #P ා why the clinical trial data is distorted? Laws and regulations are implemented in a sound way China has strict clinical trial specifications and access procedures, but the clinical trial data is distorted "Under strict laws and regulations, the implementation process has been discounted," Cai xuliu, general manager of Beijing Jingwei legend company, told reporters Compared with the United States, China's drug review centers have fewer staff, more review items, and the clinical research links cannot be effectively connected, and the "data" that can be relied on is limited, which results in the different drug review mechanism between China and the United States China's drug review is barrel shaped, and the basically imported drugs can be exported, while the FDA's drug review in the United States is funnel-shaped, wide imported and strict exported, and the FDA's new drugs in the United States can be exported before they are put on the market The control is very strict, and there are many inferences in the clinical trial data in China, 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 review center, said at the first clinical research quality (process control) Symposium on "innovation, safety and responsibility" on October 22 If such a conference was held a few years ago, there would not be so many entrepreneurs interested in the authenticity of the clinical trial data, but today, this topic is cited So much discussion and attention shows that our pharmaceutical companies attach great 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" In 2004, the former State Food and Drug Administration issued the measures for the accreditation of drug clinical trial institutions (Trial); in 2007, the measures for the administration of drug registration came out In 2010 and 2011, the former State Food and Drug Administration successively issued regulations and relevant guiding principles such as measures for the administration of drug registration, guidelines for ethical review of drug clinical trials and guidelines for the administration of biological sample analysis laboratories in drug clinical trials (Trial) China's current drug clinical trial management standard (GCP) 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 has focused on strengthening the centralized control of the approval right and management right of clinical research, that is, the approval of research requires higher system requirements It is reasonable to say that the current quality supervision system of drug clinical trials in China is very complete, but the recognized status quo is that the data of clinical trials in China are not widely recognized by the international community, and the quality of clinical trials is not satisfactory     In this regard, the relevant person in charge of SFDA drug review center said that although the relevant laws and regulations are strict, the implementation link has been discounted by different executors: the certification assessment is not strict, the base management is not in place, researchers are too busy and unfamiliar with GCP (clinical trial specification), cro company (contract research organization) pursues profits, SMO company (base management organization) helps fake, and the enterprise is not professional and not heavy Regard.. All of these are the reasons for the poor quality of clinical trials in China #P ා the lack of supervision in the clinical research process of the third-party inspection company is expected to drive the function of supervision, which will stop the new drug investment, 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 inquire the publicity information of drug clinical trials carried out in China, understand and promote the standardization of drug clinical trials, and play the 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, problems are found and analyzed, inspection reports are written and provided