“There are currently more than 600 drug clinical trial institutions across the country. Most of the research institutions have a lack of liquidity saturation, and only undertake a small number of projects, while top-level clinical institutions are full of projects, and the liquidity has reached saturation.†1 On the 5th, seven associations and institutions such as the Chinese Pharmaceutical Association Clinical Evaluation Research Committee and the Peking University Clinical Research Institute jointly released the report “Promoting the Design and Implementation of Clinical Research System and Deepening the Construction of Medical Innovation Ecosystem†(hereinafter referred to as the report). . At the report release site, Xu Zhongyuan, director of the Drug Clinical Trial Center of Southern Medical University of Southern Medical University, said.
In 2017, from January to October, the number of chemical substances in the 1.1 class (new class 1) and biological class 1 approved by clinical research was about 3 times that of 2014. In contrast, China obtained the "Quality Management Standard for Drug Clinical Trials". The number of institutions certified by (GCP) did not change significantly from 2014 to 2016, and the 168 new drug clinical trial institutions in 2017 did not have the capacity to conduct clinical trials of innovative drugs. "If this bottleneck problem cannot be effectively resolved in the next few years, it may delay the development of China's pharmaceutical innovation industry for at least 5 to 10 years." Wang Jin, one of the main writers of the report and a managing partner of McKinsey & Company, said.
It is worth looking forward to the recent introduction of a series of policies by various ministries and commissions to further promote the improvement of clinical research capabilities. In particular, on October 23, 2017, the State Food and Drug Administration issued the "Amendment of the Drug Administration Law of the People's Republic of China (Draft for Soliciting Opinions)", which is intended to promote the conversion of drug clinical trial institutions from qualification to implementation.
Quantifying drug clinical research resources
The report analyzes the differences in clinical trials between China and other 11 major global pharmaceutical innovation countries including the United States, the United Kingdom, and Germany from four indicators, which are the total number of interventional clinical trials (not included in the bioequivalence trial). The number of Phase I clinical trials, the number of international multicenter clinical trials, and the number of top clinical research papers. The results show that the current level of clinical research in China ranks ninth among the world's leading innovation countries, after Asia and Japan.
From the total number of interventional clinical trials, the total number of clinical trials in China from 2014 to 2016 was 1,705, ranking sixth among 12 countries, and the number of US data was 7,768. From the number of Phase I clinical trials in the clinical trials of interventional drugs initiated by pharmaceutical companies (not counting bioequivalence trials) initiated in 2016, the gap between China and leading countries is further evident. The United States, the United Kingdom, and Germany initiated 233, 117, and 87 tests, respectively, and China’s data was only 39. Judging from the proportion of international multi-center clinical trials in phase II and phase III clinical trials of drug-initiated drug-initiated drugs initiated in 2016, China's data is 26%, ranking the last. From the number of research reports published in the main journals of the three top international academic journals of the Lancet, New England Journal of Medicine and the Journal of the American Medical Association from 2014 to 2016, the number of articles in China is 29. The top three countries in the United States, the United Kingdom, and Canada, ranked 1084, 321 and 110, respectively.
“The ratio between clinical research and corresponding basic research in China is worthy of attention.†Wang Jin introduced that in the same period of time, there were 140 basic research articles in the life sciences published by leading Chinese academic journalists in the world's top academic journals. , is nearly five times the number of clinical research articles.
Researchers are the core of clinical trial quality
The study found that the low start-up efficiency of clinical trials, clinical research capabilities and insufficient resources are the main factors that constrain the improvement of clinical research in China. Among them, the researchers are the core factors that determine the quality of clinical trials.
In the past three years, the multi-center key research behind the 37 first innovative drugs approved by the US Food and Drug Administration (FDA) has been associated with 40 research papers, and there are no Chinese researchers among the lead researchers. From the perspective of talent introduction, there are also shortcomings in the introduction of high-level talents in clinical research. Taking the eleventh “Thousand Talents Program†youth project in 2015 as an example, only 3 of the 661 “Thousand Talents†youth talents are related to medicine. "Their research direction is basic medicine, and there is still a certain distance from clinical research." Wang Jin added.
From 2014 to 2016, only one-third of drug clinical trial institutions participated in more than 20 clinical trials. Of the 274 institutions that have participated in international multi-center clinical trials, only about one-third have undertaken more than 10 international multi-center clinical trials in the past three years. Wang Jin said: "These figures let us see the reality that our team of researchers has not been able to participate in the most advanced international trials in the past, and our clinical trial institutions are relatively weak in clinical trials."
The "main battlefield" of clinical research is in the hospital, and the main body is a doctor. Under this circumstance, the participation of clinical trials in China's drugs is weak, and may be affected by the incentive mechanism of hospitals and doctors. Among the hospital's grades and specialist assessment criteria, the proportion of clinical research institutes is low. Of the 636 clauses in the “Triple General Hospital Accreditation Standardsâ€, only two involve clinical trials, and only the oncology and the national clinical key specialist assessments. The pharmacy department involves clinical trial-related indicators, and the proportion of scores is not high. In the performance appraisal indicator system for hospital leaders and medical staff, the degree of recognition for undertaking and participating in clinical trials is not high. Therefore, the motivation of medical staff to carry out clinical research is insufficient.
Breaking through the bottleneck needs more power
Experts call for greater emphasis on clinical trials from the top-level design level. Xu Zhongyuan believes that if clinical research participants can be recognized in the top-level design, incorporating clinical research into the performance appraisal system of medical staff will stimulate their participation in clinical research and improve the efficiency of clinical research.
Specific to the design and implementation of clinical trials, the report recommends that while the sponsors are improving their capabilities, the hospital must also change its philosophy and clarify its position as a GCP clinical drug research institution, rationalizing the relationship between clinical research and departmental and doctoral work. Relationship. Wu Yangfeng, executive deputy director of Peking University Clinical Research Institute, agreed. He pointed out that hospitals in China that have produced clinical research results that can influence international clinical guidelines have excellent clinical research teams and platforms.
Fortunately, in July 2017, the Ministry of Science and Technology, the National Health and Family Planning Commission, the Military Logistics Department and the State Food and Drug Administration issued the "National Clinical Medical Research Center for Five Years (2017-2021) Development Plan" (hereinafter referred to as Three documents, such as "Planning", are regarded by the industry as an important achievement in the top-level design of the clinical research system. Regarding the performance appraisal of clinical researchers concerned by the industry, the "Planning" proposes to "improve the proportion of the results of the transformation of scientific research personnel's achievements, and study the breakthrough of the incentive policy for promoting clinical research labor compensation."
In addition, it is necessary for China to strengthen personnel training, subject education and subject protection. Xu Zhongyuan puts forward suggestions from the perspective of talent cultivation. He believes that on the one hand, it is necessary to set up relevant majors in universities, to train a full-time talent team through systematic clinical research curriculum, to improve the continuing education system, and to conduct long-term participation in clinical research. Training. At the same time, he also pointed out the urgency of the subject's education. "We are now facing the problem of enrollment difficulties and insufficient subjects." Xu Zhongyuan called on the public to correctly understand and support clinical trials. (China Medical News)
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