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    Home > Biochemistry News > Biotechnology News > The current situation and challenges of clinical trial development in China

    The current situation and challenges of clinical trial development in China

    • Last Update: 2020-06-17
    • Source: Internet
    • Author: User
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    First, backgroundclinical trial is a key link in the drug innovation industry, is the only way to verify the safety and efficacy of drugs in the human body, but also the drug research and development process of the most financial and time investmentin recent years, the state has issued a series of biopharmaceutical development plans and drug management reform policies, especially drug clinical trial data verification, generic drug consistency evaluation, drug listing licensor system and other supporting drug registration and approval reform policies, and vigorously promote the development of the biopharmaceutical industry, the current situation of china's clinical trial developmentChina's innovation drug development started late, in the initial stage of innovation, clinical research is in the lack of national strategic level of the top-level design and planning, the regulatory system is also in the stage of gradualimprovement, industrial chain institutions, CRO enterprises, etcare lack of rich experiencethe past medical research focus on the basic clinical, lack of strategic planning and top-level design of the development of clinical research system, in the past few decades the financial support in the field of medical science focused on basic medical research, lack of support for the researchers initiated interventional clinical trials, scientific research fund management and assessment methods also lack of consideration of the objective law of clinical researchthe construction of clinical research center system lags behind, resources are highly dispersed, the composition is single and the collaboration between the centers is not smoothEffective hospital and doctor incentives have not yet been established to support researchers in clinical studiesThe medical personnel education training system and the national talent plan also pay insufficient attention to clinical researchThese problems lead to a shortage of high-level talents in clinical research, and the overall level of participation and motivation of doctors is not high1The lack of superior clinical resourcesas of May 2019, there are 744 qualified institutions for drug clinical trials in ChinaOn August 26, 2019, a new version of the Drug Administration Act was passed and will come into effect on December 1, 2019, with the drug clinical trial institutions implementing the filing managementthis means that there will be more clinical trial institutions can support the development of new drugs, but in fact, due to the lack of past clinical trial experience and the aggregation effect of high-quality medical resources, the real clinical research capacity of the institutions are limited, if a large number of clinical trial institutions their experimental capacity is not rapid and effective training and upgrading, will still not be able to solve the problem of clinical resource constraints, research capacity and trial experience of the institutions are still required by enterprises to compete for resourcesuneven distribution of resources in health care institutions led to the concentration of the distribution of dominant clinical trial institutions, as of May 2019, CDE registered 33638 clinical trials (excluding BE), Beijing, Shanghai and other 10 provinces (municipalities, autonomous regions) Of The GCP institutions to undertake 60% of the country's clinical trials Figure 1 The share of clinical number of clinical units in different provinces (municipalities and autonomous regions) accounts for the number of clinical applications in the country
    data source: Drug clinical trial registration and information disclosure platform 2 GCP institutions inefficient, imperfect system, long test cycle, lack of industry standards
    most GCP institutions have not yet established a sound clinical trial management and support system, facing the lack of clear provisions of the positioning of the office, functions and staffing, resulting in the lack of enthusiasm of test managers, management process to be optimized, clinical trial management lack of process management tools, such as inefficient start-up and closure of the pilot contract communication and other projects, resulting in a lot of time waste the lack of clear standards and transparent and efficient processes for the allocation of clinical trial service fees affected the enthusiasm of the team of researchers and greatly hindered the rapid progress of the trial In addition, most GCP institutions have problems such as inefficient multi-center ethical review in the context of the rapid growth of clinical demand 3 Lack of talents, homogenization competition, high cost of enterprise research and development
    China's medical personnel education and training system is concentrated in the field of basic research and drug discovery, resulting in the lack of clinical research personnel and specialized research team, coupled with China's lack of experience in innovative drug research and development, resulting in the lack of drug testing program design capacity, program homogenization competition, research and development success rate Reducing, and leading to a large number of clinical resources and patient resource depletion, while clinical trial-related personnel become the resources of pharmaceutical companies and CROs, resulting in the continuous increase of the cost of clinical trials, institutional clinical trial management personnel also lack, resulting in low efficiency of trial management, the lack of PI talent with research capabilities, resulting in low trial quality control and many other problems 4 The lack of patient resources, the difficulty of recruiting subjects the lack of patient resources are mainly due to the competition of superior clinical resources and the lack of effective clinical trial patient education in China The lack of patient resources is largely due to the limited number of high-quality institutions involved in clinical trials, China has a large population advantage, can provide a sufficient source of subjects for various types of diseases, coupled with the increasing number of GCP institutions in recent years, as well as the upcoming clinical trial institutionfiling system, are conducive to the full expansion of the subject's source But the lack of resources for subjects is further aggravated by the limited sources of recruitment of subjects due to the large number of trials concentrated in a limited GCP facility with superior clinical resources Finally, the lack of correct understanding of clinical trials is also one of the important reasons for the recruitment difficulties of subjects , summary clinical research is an irreplaceable step in the pharmaceutical innovation industry chain, but also the most investment time and resources of the stage, is the most important link of the entire pharmaceutical innovation ecosystem, fast reading to enhance clinical research capabilities, in order to grasp the new opportunities for the development of pharmaceutical innovation industry In addition to establishing and perfecting policies and regulations and perfecting the top-level design, the should also promote the design and implementation of clinical research systems, including reforming hospital rating and doctor's title evaluation methods, optimizing the management of clinical trial centers and full-time personnel management, improving the ethical review system, strengthening the training of clinical research personnel and popular science education In addition, , deepen the construction of the pharmaceutical innovation ecosystem, make full use of big data and AI technology, establish a clinical research service platform, set up a national and regional clinical research center, set up a clinical research service platform connecting institutions, enterprises, service providers, etc., promote the development of national and regional clinical research societies or associations, increase cooperation among the centers, promote the level of clinical research of non-head GCP institutions, and thus lead the role of leading and rapidly expanding clinical resources.
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