7 institutions call for clinical research development, to eliminate innovation bottlenecks in China’s pharmaceutical industry



[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.  


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