With the encouragement of national policy on drug and medical device innovation, multi-center clinical trials and multi-regional clinical trials are facing an unprecedented opportunity in China. Trials with a multi-center design are far more common at present than before. However, it should be recognized there still exists shortcomings in current multi-center trials. In this paper, we summarize the problems and challenges and provide corresponding resolutions with the aim to reduce heterogeneity between study centers and avoid excessive center effects in treatment. It is urgent to develop design, implementation and reporting guidelines to improve the overall quality of multi-center clinical trials.
Citation:
DONG Chongya, YAN Xiaoyan, YAO Liang, BIAN Zhaoxiang, YAO Chen. Developing design, implementation and reporting guidelines for multi-center clinical trials is imperative. Chinese Journal of Evidence-Based Medicine, 2018, 18(7): 654-656. doi: 10.7507/1672-2531.201801072
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Copyright ? the editorial department of Chinese Journal of Evidence-Based Medicine of West China Medical Publisher. All rights reserved
| 1. |
中共中央辦公廳, 國務院辦公廳. 關于深化審評審批制度改革鼓勵藥品醫療器械創新的意見. Available at: http://www.gov.cn/gongbao/content/2017/content_5232362.htm.
|
| 2. |
ICH Expert Working Group. ICH harmonized tripartite guideline e9 - statistical principles for clinical trials. Available at: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf.
|
| 3. |
國家食品藥品監督管理總局. 國際多中心藥物臨床試驗指南(試行). Available at: http://www.sda.gov.cn/WS01/CL0087/114002.html. 2015-01-30/2018-01-01.
|
| 4. |
ICH Press Release. Press release ICH Assembly meeting in Montreal, Canada. Available at: http://www.ich.org/ichnews/newsroom/read/article/press-release-ich-assembly-meeting-in-montreal-canada-mayjune-2017.html.
|
| 5. |
國家食品藥品監督管理總局. 藥物臨床試驗的生物統計學指導原則. Available at: http://www.sda.gov.cn/WS01/CL0087/154780.html.
|
| 6. |
Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ, 2010, 340(7748): 698-702.
|
- 1. 中共中央辦公廳, 國務院辦公廳. 關于深化審評審批制度改革鼓勵藥品醫療器械創新的意見. Available at: http://www.gov.cn/gongbao/content/2017/content_5232362.htm.
- 2. ICH Expert Working Group. ICH harmonized tripartite guideline e9 - statistical principles for clinical trials. Available at: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf.
- 3. 國家食品藥品監督管理總局. 國際多中心藥物臨床試驗指南(試行). Available at: http://www.sda.gov.cn/WS01/CL0087/114002.html. 2015-01-30/2018-01-01.
- 4. ICH Press Release. Press release ICH Assembly meeting in Montreal, Canada. Available at: http://www.ich.org/ichnews/newsroom/read/article/press-release-ich-assembly-meeting-in-montreal-canada-mayjune-2017.html.
- 5. 國家食品藥品監督管理總局. 藥物臨床試驗的生物統計學指導原則. Available at: http://www.sda.gov.cn/WS01/CL0087/154780.html.
- 6. Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ, 2010, 340(7748): 698-702.