In order to answer this false proposition of minority selection, the report has to give a false response to the current situation of Chinas medical industry, so as to make a partial summary. At the same time, the reports deliberate overlook of the risks of clinical trials abroad is also very dangerous. Once the public is ignorant of the danger of clinical trials, it is likely to arouse the desire of the public to follow suit. Through consulting the industry experts, the science and Technology Daily reporter summarized several obvious fallacies of the report.
Taking foreign clinical trials
It uses an unforgettable analogy: its like the United States is using the iPhone 6, and were still using the iPhone 3.
Compared to the iPhone 6, clinical trials were conducted in the United States, while compared to the iPhone 3, clinical treatments were conducted in China.
A drug from embryonic form to market is a long process. It is generally believed that the cost of investment is about $1 billion, which takes 10 years, and has a very high elimination rate.
This process can be roughly divided into pre clinical and clinical trials. The former includes compounds of drug precursors, pharmacokinetics and pharmacodynamics analysis, and effective safety tests at cellular and animal levels. When these experimental processes have obtained good data, they can be approved for clinical trials by administrative departments such as the Food and Drug Administration. After scientifically designed and strictly implemented clinical trials, they can be submitted to the drug approval department for approval, and new drug certificates can be obtained, then they can be listed for clinical treatment.
But for the special field of new drugs, only a small number of prototype can really go public. Fan Daiming, an academician of the Chinese Academy of Engineering, cited a group of cases in which 101 major discoveries were published in papers covering the most authoritative CNS (Cells, Nature and Science) on potential drug targets, only one of which had clinical value 20 years later.
That is to say, the clinical trial distance from the surface of clinical treatment seems to be only that card, but that card is comparable to Longmen, the difference before and after can be seen as carp and golden dragon. It is not true to compare simply from the age.
Avoiding the high risk of clinical treatment
The greatest correlation with patients themselves, and the greatest difference between clinical trials and clinical treatment, lies in the different risks.
In August 30, 2017, the first CAR-T therapy was approved in the United States. However, in April of that year, in another companys clinical trial of CAR-T drugs, a patient with refractory non-Hodgkins lymphoma (NHL) died of brain edema. Even a few days after the approval of CAR-T therapy, Cellectis, a French cell therapy company, experienced a clinical death.
Clinical trials of innovative drugs are highly risky, and phase 1 trials are more risky because this is the first clinical trial to be used in humans. Zhao Liyan, the ethics committee of Peking University Medical Department, said that although safety and effectiveness had been tested in vitro on cells and model animals, there were differences between animals and humans, so there was a great risk in humans.
For example, in 2006, TeGeneros anti-CD28 monoclonal antibody TGN1412 from Germany carried out phase I clinical trials of drugs. There were 8 subjects, of whom 2 were injected with placebo and 6 were injected with real drugs. Within half an hour, all of the six new drug subjects had severe adverse reactions such as dyspnea, palpitation and systemic swelling. They were sent to the intensive care unit, but fortunately no one died.
In this paper, only cases with positive signs were recorded in clinical trials, but the great risks of clinical trials themselves were not mentioned.
Deliberately belittle the current medical level in China
The article Why do these cancer patients go to the United States deliberately depreciates the current medical level in China. For example, the article mentions that clinical medicine in the United States is moving toward precision medicine. A patient is often treated by doctors from multiple disciplines. In fact, in many hospitals in China, multi-disciplinary consultation has become a routine system for the diagnosis of difficult and complicated diseases in many hospitals, even through telemedicine and other means of cross-hospital expert consultation.
In addition, Chinas medical resources are recognized by the world as an advantage. The clinical medical technology of our country is advanced in the world, and the clinicians of the first-class hospitals in our country also have more abundant clinical experience. Lu Lin, academician of the Chinese Academy of Sciences and professor of Peking University Medical Department, said that many patients who went abroad to see a doctor might not be able to get the best treatment.
Many of our doctors came back from abroad to learn about the situation abroad. The experience of foreign doctors is not as good as that of senior doctors in China. Lu Lin further explained that, for example, the major hospitals in Beijing mostly use the worlds top equipment. If you visit these hospitals, you will actually see the best hospitals and doctors in the world.
The description of Chinas GCP platform is partial.
The description of Chinas GCP platform is also inconsistent with reality. The GCP platform is the demonstration platform for the management of clinical trials of drugs. Relevant data show that China promulgated the Standards for Quality Management of Drug Clinical Trials in 2003, carried out special inspection in 2006, flight inspection and registration verification, and then improved the standard of identification and review. The national Eleventh Five-Year and Twelfth Five-Year major new drug creation special plans also gave strong support.
The comments of the respondents may reflect the adverse events of some institutions and some stages, but they can not fully reflect the real scientific research level and clinical trial level of GCP platform in China.
According to the relevant data of national major new drug creation projects, 9 GCP platforms, such as Cancer Hospital, Tiantan Hospital and West China Hospital, were supported to carry out 2063 clinical trials from January 2015 to August 2017, and 708 clinical trials were completed.
Some platforms actively implement such measures as independence of clinical trial departments, full-time researchers, normalization of rotation system and standardization of performance appraisal to stimulate staff enthusiasm and improve the quantity and quality of clinical research.
Taking PLA General Hospital as an example, 402 clinical trials have been carried out in the past five years, of which 43 are clinical trials of class 1 new drugs, 66 are international multicenter trials and 8 are subject to CFDA on-site verification projects. GCP has been certified at home and abroad, endocrine has been certified by NGSP for 7 consecutive years, and ethics committee has been certified and reviewed by SIDCER. In addition, the article still has many problems that can not withstand detailed investigation. For example, it is very unscientific to judge the effectiveness, safety and stability of a therapy from the time of its emergence. For example, China has explored a new combination model of CRO (Outsourcing Service Agency of Pharmaceutical R&D Contracts) companies participating in clinical trials, whether it is more in line with Chinas national conditions, which is worth exploring, not only because it is different from the developed countries in the United States, but also as a backward model. Source: ScienceDaily daily Author: Zhang JASUN editor in charge: Huang Jia _NNB6466
Taking PLA General Hospital as an example, 402 clinical trials have been carried out in the past five years, of which 43 are clinical trials of class 1 new drugs, 66 are international multicenter trials and 8 are subject to CFDA on-site verification projects. GCP has been certified at home and abroad, endocrine has been certified by NGSP for 7 consecutive years, and ethics committee has been certified and reviewed by SIDCER.
In addition, the article still has many problems that can not withstand detailed investigation. For example, it is very unscientific to judge the effectiveness, safety and stability of a therapy from the time of its emergence. For example, China has explored a new combination model of CRO (Outsourcing Service Agency of Pharmaceutical R&D Contracts) companies participating in clinical trials, whether it is more in line with Chinas national conditions, which is worth exploring, not only because it is different from the developed countries in the United States, but also as a backward model.