Along with economic development and the intensification of aging, people's health awareness is increasing, and the demand for Pharmaceutical products continues to increase. According to the analysis of the Frost & Sullivan Report, the size of the global pharmaceutical market has increased from approximately US$110.5 billion in 2015 to US$1324.5 billion in 2019; it is estimated that by 2023, the global pharmaceutical market will grow to US$1.6 trillion. Clinical trials are a crucial intermediate link for the high-quality development of pharmaceutical R&D innovation. The rapid growth of the pharmaceutical market is inseparable from the expansion of clinical trial scale and continuous innovation. Public data shows that the number of global clinical trials in 2015 was only 2,137; to In 2019, the number was as high as 6,939. According to relevant reports of China Report Network, by 2024, the total market size of the three research phases of drug discovery, preclinical and formal clinical research will reach approximately US$96 billion, of which the clinical phase CRO is approximately US$62.2 billion, accounting for approximately 64.79%.
Faced with such a huge and attractive market pie, what is the current status of China's pharmaceutical innovation clinical trial research? What stage has it developed? Where will it go in the future? Professor Ouyang Dongsheng of the Institute of Clinical Pharmacology, Xiangya Hospital of Central South University, and a doctoral supervisor, Chairman of Changsha Duzheng Biotechnology Co., Ltd., presented at the “2021 High-quality Development Conference of the Health Industry and the Sixth China Pharmaceutical Research and Innovation Summit (PDI) )" In his speech on "The Development Status and Trends of the Clinical Trial Industry", through data analysis, he pointed out the problems and gave clear directions.
Current situation The clinical data has expanded dramatically, but the results are worth considering
Ouyang Dongsheng pointed out that since the implementation of reforms and encouragement of innovation in a number of intensified medical policies including clinical trial data verification, consistency evaluation, review and approval reforms in China in 2015, innovative medicines have turned the cloud into a fog, and the research and development of innovative drugs has spurted out. The demand for testing has expanded dramatically. According to data reported by China Report Network, the number of clinical trials in China increased from 339 in 2015 to 1031 in 2019, with an average annual growth rate of approximately 32.06%.
According to the 2020 China Drug Clinical Trial Analysis Report, there will be a total of 2,086 clinical applications in 2020, an increase of 48% year-on-year, and a rapid increase of 1,048 clinical trial applications in three years, with an approval rate of almost 100%. In addition, the number of trials registered in CDE drug clinical trials in 2020 is 2,562, an increase of 7% year-on-year.
"The rapid growth of clinical trial data reflects the speed of the rise of China's pharmaceutical innovation, but it still has a certain gap with the pharmaceutical powers. Among them, whether 10% of the clinical trials can achieve the transformation of results is a question worth considering. After all, The new drug R&D investment is large, the risk is high, and the cycle is long." Ouyang Dongsheng said, "Especially in July this year, the "Clinical Value-Oriented Oncology Drug Clinical R&D Guidelines" was issued for comments, emphasizing that clinical trials are based on clinical needs. As a guide, after raising the requirements for drug R&D clinical trials, whether it is an innovative drug or a counterfeit innovative drug, the threshold has been raised to achieve the ultimate victory."
Pain points The four element problems are the key
In the context of this innovative clinical research, where is the key to the development of clinical trials? Ouyang Dongsheng pointed out that the four core elements of clinical trials (drugs, institutions, subjects, and ethics) are the key. The healthy development of the four elements leads to the healthy development of the entire industry. From the perspective of drug elements, comparing the approval status of new drugs, improved new drugs and generic drugs in China and the United States, my country's generic drug research and development capabilities are basically close to those of world-class countries, and innovative drugs are far from improved new drugs. However, in recent years, under the international medical policy that encourages medical innovation, the total number of new drug applications in my country has been increasing year by year. Therefore, it is necessary to continuously improve the ability of new drug research and integrate China's clinical trial capabilities with international standards, especially in the direction of innovative tumor drug research and development.
In terms of institutions, according to public data, as of April 8, 2021, there are 1044 GCP institutions nationwide (filed), covering all provinces (municipalities and autonomous regions) across the country. The number is sufficient, but the capabilities are uneven and the distribution is uneven. Guangdong, Jiangsu, Shandong, Beijing, and Shanghai GCP institutions account for nearly 35% of the total number of institutions, and they have undertaken the vast majority of clinical research in the country; most provinces in the western region There is a serious lack of municipal institutions. These are the pain points and difficulties that urgently need to be resolved in the high-quality development of clinical trials. In terms of subjects, subjects directly affect whether the clinical trial industry can develop healthily. Unhealthy and irrational professional testers should not be allowed to disrupt the development of new drugs; at the same time, in the face of the problem of dispersing patient resources in clinical trials of new drugs, resource allocation and institutional layout should be reasonably adjusted. From the perspective of experimental ethics, ethics has become a bottleneck hindering the efficiency of clinical trials. Although the country is establishing corresponding rules and conducting unified regulatory filings, the current ethics committee has many problems such as irregular committee qualifications, membership qualifications, different levels of review and evaluation standards, lack of continuous follow-up review, and low review efficiency. Therefore, Ouyang Dongsheng stated that only by solving the four major element problems in clinical trials, can China's clinical trial industry develop healthily in the future and help China's biomedical innovation research and development.
Where is the way forward?
So, in the face of many difficulties, where is the current development path of clinical trials in China? How to go? Ouyang Dongsheng said that on the one hand, it is to develop new cooperation models, use medical community, medical consortium, medical alliance and other methods to integrate resources to improve efficiency; second, focus on new professions, demand-oriented, and patient-centric , Fundamentally raise problems and solve problems; third, explore new types of research, logical reconstruction of drug R&D, real-world research, ITT, etc. may become new entry points; fourth, use new technical means to fully integrate digital technology Enter into clinical trials, make clinical research informatized and intelligent, and form a unified information management system, so as to establish a clinical research informatization technology platform and a pharmaceutical research informatization platform to solve the problems of online promotion and on-site verification of clinical trials. Clinical trials are a sacred cause and the epitome of the progress of human civilization! China's new drug R&D clinical trials have a long way to go.
September 30, 2021
