[Beijing · January 5, 2018] Today, seven institutions jointly released the research report titled Deepening the drug innovation ecosystem reform -- A plan to design and build China's clinical research system, arguing that clinical research is the most important link in the entire pharmaceutical innovation ecosystem. If issues on clinical research capacity and resources are not resolved in time, the growth of China's innovative medicine industry will be hindered for at least 5 to 10 years. Therefore, it is suggested that China should improve the clinical research and development strategies at the national level. The country should raise awareness, clarify the enhancement of clinical research capability as one of the healthcare reform targets, and set both short-term and long-term goals for clinical research development.
Clinical research concerning people's livelihood and innovation
Healthy China 2030 explicitly put forward to "eliminate a number of major disease hazards". Many serious and chronic disease treatment programs shall be based on scientific data drawing from clinical research on Chinese people, so that they can be the references for evidence-based medicine, and to continuously uplift the level of diagnosis and treatment in China. Concerning a number of high-incidence and severe diseases in China (such as liver cancer, gastric cancer, esophageal cancer and hepatitis B), little innovation has emerged across the world. So it is even more necessary for Chinese medical workers to explore solutions through clinical research. In the meantime, clinical trial is also the only way to verify the safety and efficacy of drugs in human body, and the only route leading towards the development of innovative drugs. Hence, Clinical research is the vital approach to tackle the unmet clinical needs of Chinese patients and safeguarding people's livelihood.
Inadequate clinical research capability in China
There are still challenges for China to rely on the existing capabilities and resources of clinical research to achieve the goal required by the Health China 2030 as "the overall strength of health technology innovation ranks among the best in the world". Taking clinical research resources as an example: the number of clinically approved Class 1.1 chemical drug (Class 1 new drug) and Class 1 biomolecule from January to October 2017 is three times the number in 2014. Yet, there was no significant changes in the number of institutions accredited by GCP (Good Clinical Practice) in China between 2014 and 2016, and the 168 newly established institutions in 2017 are basically unqualified for conducting clinical trials on innovative drugs. In the meantime, according to the data comparison from 2014 to 2016, the number of paper published by Chinese researchers on clinical research magazines such as The Lancet, The New England Journal of Medicine and The Journal of the American Medical Association ranked No. 9 among 12 countries, only 2.7% of the US.
Improve top-level design of clinical research, building world-class clinical innovation system
For the past 15 to 20 years, the government subsidy to medical science has been focused “more on foundation, and less on clinical” in China. For instance, among the medical science related research topics approved to receive grants from the National Natural Science Foundation of China in 2016, 95% belonged to basic medicine yet only 5% was used to support clinical research. Similarly, in 2016, the National Key R&D Program launched a total of 299 biological and medical projects in 7 categories, of which only 13% were used for clinical research. Hence, the proportion of government scientific research funds dedicated to clinical field needs to be increased.
Currently, hospitals and doctors are not motivated to participate in clinical researches due to the appraisal system of hospitals and doctors. This is because basic researches are characterized by shorter cycle, smaller investment, and more likeliness to be published. In comparison, high-level clinical research often requires larger scale of financial support, longer testing cycles and higher demands on researchers and support teams. Given that the relatively large number of participants and fewer opportunities to gain authorship in publications make it difficult for researchers to meet the number of published papers required for their job promotion, they are generally less motivated as the result. Therefore, there is an urgent need to establish medical institutions to undertake clinical research and an incentive mechanism for researchers.
In order to further encourage innovation and promote clinical research capabilities, recently, various state ministries and commissions have released a series of policies: In July 2017, the Ministry of Science and Technology, the National Health and Family Planning Commission, the Logistic Support Department of the Central Military Commission and the China Food and Drug Administration formulated and issued the Five-Year Development Plan of National Clinical Research Center (2017-2021), the Administrative Measures for National Clinical Research Center (Revised in 2017) and the Operational Performance Evaluation Program of National Clinical Research Center (Trial), putting forward the short-term goals and implementation methods of construction and development in the next five years. It is an important outcome of the top-level design of clinical research system. All seven institutions are anticipating that in the future, the government could further clarify its role in promoting strategic implementation, provide funding for capacity-building and key area development, and establish a mechanism for inter-ministerial coordination. So as to ensure policy coherence, boost the development of clinical research, and contribute to the boom of China’s pharmaceutical innovation industry.
The Report is, under the guidance of over 40 consultants, compiled by the R&D-based Pharmaceutical Association Committee of China Association of Enterprises with Foreign Investment, the Drug Clinical Evaluation Research Committee of Chinese Pharmaceutical Association, PKU APEC Regulatory Sciences CoE, Peking University Clinical Research Institute, Chinese Pharmaceutical Enterprises Association, China Pharmaceutical Industry Association and China Chamber of Commerce for Import & Export of Medicines & Health Products.