Clinical Research of Kidney Disease in China

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1 Clinical Research of Kidney Disease in China Zhi-Hong Liu National Clinical Research Center of Kidney Diseases Jinling Hospital Nanjing University School of Medicine Nanjing, China

2 CKD:10.8% CKD:119.5 million Zhang L, et al. Lancet, 2012;379:

3 Construction of the Cause of ESRD Patients in China 3,5% 2,3% 9,8% 10,5% 16,4% 57,4% 原发性肾小球疾病 Glomerular disease DN 糖尿病肾病 Hypertension caused 高血压肾损害 renal disease 多囊肾病 Cys6c disease of kidney 肾结石 Nephrolithiasis 其它 Others * The Chinese Renal Data System (2011)

4 Different causes of ESRD in China, the USA and the UK Zhihong Liu. Nat Rev Nephrol. (2013); 9,

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6 Lancet 2013; 381:

7 Ranks for the top 25 causes of years of life lost in China for both sexes and all ages combined with 95% UIs in 1990 and 2010 and median percentage change from 1990 to 2010 Lancet 2013; 381:

8 In 2009, the Chinese government announced a healthcare reform plan to provide affordable and equitable basic universal health care by 2020, the basic medical insurance now covers over 95% of urban and rural residents.

9 Three medical insurance system in China: The urban employee basic medical insurance, which covers formal sector urban workers; The urban resident basic medical insurance, covering children, students and elderly people without previous employment; The New Cooperative Medical Scheme for residents in rural locations.

10 As CKD was defined as a major chronic disease by the Chinese government, all three basic medical insurance systems cover both haemodialysis and peritoneal dialysis, but the reimbursement rates vary from 50% to 90% across regions with different socioeconomic statuses.

11 The pharmaceutical markets are growing in China The marketing expense (a hundred million Chinese Yuan)

12 China Market Trend China Become the 5th Largest Pharmaceutical Market ( projected growth 13 18% annually)* 2002 Top Top Top 10 USA 196 USA 262 USA 466 Japan 53 Germany 20 France 19 UK 14 Italy 13 Spain 9 Japan 65 Germany 24 France 21 UK 16 Italy 15 China 14 Japan 81 Germany 37 France 28 China 24 UK 24 Italy 23 Recent data showed that China has risen to the third largest pharmaceutical market globally. Canada 8 Brazil 10 Canada 17 Mexico 8 Canada 10 Spani 16 China 6 Spain 9.8 Brazil 15 Total 346 Total 447 Total 731 *: Estimated Market Size for Ethical and OTC Drugs (US billions) Source: BCG China Report

13 Most of the drug are either generic versions or developed outside China New market Total Innovative drug

14 The increased investment by the Chinese government and multinational pharmaceutical companies are creating a stronger environment for innovative drug R&D in China. Several multinational pharmaceutical companies have now located their R&D centers in China. The Chinese government implemented a special drug R&D funding program in which $2.7 billion was invested from 2008 to 2010, with another $6 billion to follow in the next 5 years.

15 Drug Registration in China

16 Clinical Trials in China

17 Total number of clinical trials registered in different countries from % 18% 8% 11% Perspectives in Clinical Research, 2013;4(3):

18 Percentage of clinical trials registered in 2007 and 2011 in various countries Percentage change in clinical trials registered in 2007 and 2011 in various countries Perspectives in Clinical Research, 2013;4(3):

19 Disease distribution of clinical trials in different countries Perspectives in Clinical Research, 2013;4(3):

20 Number and ratio of Chinese publications on basic medical science and clinical research, The Lancet,2011;377:

21 Publications in clinical research globally ( )

22 A survey of clinical research among clinicians Population: 6 affiliated teaching hospitals of Beijing University in 2007 Results: u Time spent on clinical research: 0.5 day/wk u 96.5% considered the importance u 54.8% are participating in clinical research u Reasons for NOT participating No funding (67.6%) No time (66.5%) Insufficient research environment/policy support (35.7%) u Suggestions for enhancing clinical research capacity Leadership (60.8%) Resources (60.0%) Training & learning (54.2%) Hu Y, et al., Status of clinical research in China. Lancet.,2011,377(9760):124 5

23 The Barriers of clinical research in China The absence of systematic training for clinical research in medical education (particularly training in clinical research skills and epidemiology), many physicians do not have the skills to understand and carry out clinical research to an international standard.

24 The Barriers of clinical research in China Many physicians pay more attention to basic scientific research than to clinical research, because it is quicker, easier to get fund, and more likely to get publication. Additionally, many hospitals do not have mature, integrated platforms or systems for clinicians to do clinical research, especially the m u l t i c e n t e r c l i n i c a l t r i a l s i n C h i n a.

25 International multi-center clinical trials In China

26 International multi-center clinical trials conducted in China Ø The global new drug development and research is increasing in China Ø In 2009, 132 international multi-center clinical trial applications Ø In 2010, 168 international multi-center clinical trials applications. Changes of the Number of International multi-center clinical trials application since 2005

27 Rapid recruitment and cost savings are considered two most important benefits of conducting clinical drug studies in these emerging markets, but whether or not they follow the Good Clinical Practice (GCP) guidelines remains a critical concern. The purposes of the GCP guidelines are to protect the rights of human subjects who participate in clinical studies and to ensure the scientific validity and credibility of the data collected.

28 Contemporary Clinical Trials 2008;29:

29 The Comprehensive International Program of Research on AIDS (CIPRA)program in China, the US sponsor and designated US-based Contract Research Organization (CRO) worked closely with the Chinese investigators and their teams on the study preparation and implementation, at the same standard required for the US sites. Before the program started, all the parties worked carefully on program planning and preparation.

30 * Site visit reports of the comprehensive International Program of Research on AIDS(CIPRA) Contemporary Clinical Trials 2008;29:

31 The implemented China CIPRA program was at least comparable and equivalent to the US studies in GCP adherence,the program's GCP performance was satisfactory in overall and for the selected critical GCP items. It may provide a valuable perspective on the quality of Chinese clinical research practice.

32 The National Clinical Research Centers in China

33 To strengthen China s clinical and population research capacity and build a sustainable infrastructure to support clinical research for patients benefit, the Chinese Ministry of Science and Technology (MOST) and the National Commission for Health and Family Planning (NCHFP) collectively established the National Clinical Research Centers program in July, 2012.

34 This program will select the most outstanding clinical research centers in China that will benefit from substantial, long-term funding and policy support from the Chinese Government.

35 The selected centers will not only produce high-quality science using rigorous methods but will also expand the national research capacity by creating sustainable research networks throughout the country to undertake multicenter and multinational clinical and population research.

36 The construction of National Clinical Research Centers 临床医学研究网络布局示意图 The 国家中心 National Clinical Research Centers 核心成员 The Satellite Centers The 网络成员 Network Units

37 Multidisciplinary teams that include clinical medicine, computer science, mathematics, informatics, epidemiology, economics, sociology, and management science will be established in the centers. Additionally, the centers will promote international cooperation in health care.

38 The first priorities for the selected centers: u Cancer u Cardiovascular disease u Neurological disease u Respiratory disease u Chronic kidney disease u Metabolic disorders 13 hospitals formed the first group of Chinese National Clinical Research Centers in 2013

39 The launch of the National Clinical Research Centers program represents a new era for China s clinical research. It will aim to achieve the ultimate goal of improving health and health care through the power of science and its translation and application.

40 Thank you