Comparative Analysis of the Advantages of Clinical Research in China and India_Chinese Journal of Evidence-Based Medicine

Authors：

XU Hongjuan ^1,2 , LI Xiaofeng ³ ,  SHANG Hongcai ^1,2,4

1. Evidence-Based Medicine Centre, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China;2. Academy, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China;3. Emergency Department, Zhuozhou Second Workers Hospital of Dongfang Company, Heibei 072750, China;4. Key Laboratory of Pharmalology of Traditional Chinese Medical Formulae, Ministry of Education, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China;

Corresponding author：

SHANG Hongcai, Email: shanghongcai@foxmail.com

Keywords：

Clinical research; Advantages of resources; China; India

DOI：

10.7507/1672-2531.20090161

Video：

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In recent years, clinical research shows the trend of globalization. Due to characteristics of the huge number and relative concentration of patients, the wide variety of diseases, a high patient enrolment rate, lower trials costs, and so on, China and India become a focus of this trend. However, China and India also have their own advantages in the aspects of diseases, infrastructure, policies, regulations, regulatory environment, language, and culture. The key question to address is: how to increase the shares in the trial market in the future and to enhance the international status of China’s clinical research? Before we answer this question, we must understand the present situations of clinical research resources in China and India. So, we searched the relevant literature at home and abroad by computer and hand to analyze advantages and efficiency of clinical research resources in China and India.

Citation： XU Hongjuan,LI Xiaofeng,SHANG Hongcai. Comparative Analysis of the Advantages of Clinical Research in China and India. Chinese Journal of Evidence-Based Medicine, 2009, 09(8): 917-920. doi: 10.7507/1672-2531.20090161 Copy

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2.	Lamberti MJ, Space S, Gammbrill S. Going global. Appl Clin Trials, 2004, 13(6): 84-92.
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17.	刘杰. CRO联动. 中国医院院长, 2007, 19: 58-61.
18.	稚子归. 药物临床试验之开展篇—姿态与选择. 中国处方药, 2007, 5(62): 20-22.
19.	赖强. 积极信号背后的隐忧. 中国处方药, 2007, 8(65): 7.
20.	Nundy S, Chir M, Gulhati CM, et al. A New Colonialism? — Conducting Clinical Trials in India. N Engl J Med, 2005, 352(16): 1633-1636.
21.	毛冬蕾. 亚洲觉醒: 临床研究整体法规之变. 中国处方药, 2007, 12(69): 26-27.
22.	Sahoo U, Sawant D. The Clinical Research Profession in India. Monitor, 2007, 51-55.
23.	左根永. 以ICH-GCP为基础的国际GCP规制及对我国的启示. 中国处方药, 2007, 9(66): 41-42.
24.	Dent NJ, Krishan A. Ethics Committees in India. Qual Assur J, 2007, (11): 143-150.
25.	曹永福, 王云岭, 杨同卫, 等. 我国“医学伦理委员会”的成立背景、功能和建设建议. 中国医学伦理学, 2004, 17(5): 31-33.
26.	张利平, 王莹莹, 刘俊立. 我国医学伦理委员会组织与管理情况调查报告. 中国医学伦理学, 2008, 21(6): 128-130.
27.	Thatte UM, Bavdekar SB. Clinical research in India: great expectations? J Postgrad Med, 2008, 54(4): 318-323.
28.	Patralekha C. Clinical trials in India: ethical concerns. Bull World Health Organ, 2008, 86(8): 581-582.
29.	李幼平, 杜亮, 王莉, 等. 借鉴循证医学理念方法，提高我国新药审评质量. 中国循证医学杂志, 2006, 6(12): 851-854.
30.	王婧. 中国药物研发: 如何与高手过招? 科技中国, 2007, 11: 66-71.
31.	栾雪梅. BMS: 开展临床研究, 中国和印度一个都不能少. 中国处方药, 2007, 6(63): 33.
32.	Mukherjee S. Pharmaceutical Research Development in India – Looking Up? Future Drug Discovery, 2006, 73-77.

1. 栾雪梅. BI: 开展临床研究,我们选择中国. 中国处方药, 2007, 6(63): 32.
2. Lamberti MJ, Space S, Gammbrill S. Going global. Appl Clin Trials, 2004, 13(6): 84-92.
3. Singh R. Clinical research in China and India: a paradigm shift in drug development. Drug Discovery Today, 2006, 11(15-16): 675-676.
4. 中国处方药编辑部. 流动的世界——“药物临床试验在中国”高端对话. 中国处方药, 2007, 7(64): 25-31.
5. Jack A, Yee A. China overtakes India in drug testing. The Financial Times, 2007, Aug. 28.
6. 栾雪梅. 临床试验: 向新兴国家进发. 中国处方药, 2007, 5(62): 23-25.
7. Kingsbury K. China’s Drug Addiction. Time, 2007, Nov. 14.
8. 毛冬蕾, 栾雪梅. CRO, 连接梦想. 中国处方药, 2007, 9(66): 21-23.
9. Wong G. Can China’s supply of scientific talent keep up with demand? Nature Biotechnology, 2008, 26(2): 243-244.
10. Maiti R, Raghavendra M. Clinical trials in India. Pharmacological Research, 2007, 56(1): 1-10.
11. Varawalla N. India’s growing clinical research sector: Opportunity for global companies. IDrugs, 2007, 10(6): 391-394.
12. Sinha G. Outsourcing drug work: pharmaceuticals ship R&D and clinical trials to India. Scientific American Online, 2004, 291(2): 24-25.
13. 稚子归. 在梦想和现实之间, 做出选择. 中国处方药, 2007, 6(63): 19-23.
14. 张蕊. 中印两国制药产业状况对比. 上海医药, 2006, 27(3): 106-108.
15. 王静波. 从环境与发展动态看印度制药业较中国制药业的优势所在. 竞争情报, 2007, 2: 45-53.
16. 林坤. CRO的中国式崛起. 中国卫生产业, 2007, 6: 59-62.
17. 刘杰. CRO联动. 中国医院院长, 2007, 19: 58-61.
18. 稚子归. 药物临床试验之开展篇—姿态与选择. 中国处方药, 2007, 5(62): 20-22.
19. 赖强. 积极信号背后的隐忧. 中国处方药, 2007, 8(65): 7.
20. Nundy S, Chir M, Gulhati CM, et al. A New Colonialism? — Conducting Clinical Trials in India. N Engl J Med, 2005, 352(16): 1633-1636.
21. 毛冬蕾. 亚洲觉醒: 临床研究整体法规之变. 中国处方药, 2007, 12(69): 26-27.
22. Sahoo U, Sawant D. The Clinical Research Profession in India. Monitor, 2007, 51-55.
23. 左根永. 以ICH-GCP为基础的国际GCP规制及对我国的启示. 中国处方药, 2007, 9(66): 41-42.
24. Dent NJ, Krishan A. Ethics Committees in India. Qual Assur J, 2007, (11): 143-150.
25. 曹永福, 王云岭, 杨同卫, 等. 我国“医学伦理委员会”的成立背景、功能和建设建议. 中国医学伦理学, 2004, 17(5): 31-33.
26. 张利平, 王莹莹, 刘俊立. 我国医学伦理委员会组织与管理情况调查报告. 中国医学伦理学, 2008, 21(6): 128-130.
27. Thatte UM, Bavdekar SB. Clinical research in India: great expectations? J Postgrad Med, 2008, 54(4): 318-323.
28. Patralekha C. Clinical trials in India: ethical concerns. Bull World Health Organ, 2008, 86(8): 581-582.
29. 李幼平, 杜亮, 王莉, 等. 借鉴循证医学理念方法，提高我国新药审评质量. 中国循证医学杂志, 2006, 6(12): 851-854.
30. 王婧. 中国药物研发: 如何与高手过招? 科技中国, 2007, 11: 66-71.
31. 栾雪梅. BMS: 开展临床研究, 中国和印度一个都不能少. 中国处方药, 2007, 6(63): 33.
32. Mukherjee S. Pharmaceutical Research Development in India – Looking Up? Future Drug Discovery, 2006, 73-77.

Chinese Journal of Evidence-Based Medicine

Comparative Analysis of the Advantages of Clinical Research in China and India

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