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
Copy
| 1. |
中共中央办公厅, 国务院办公厅. 关于深化审评审批制度改革鼓励药品医疗器械创新的意见. 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. |
国家食品药品监督管理总局. 国际多中心药物临床试验指南(试行). 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. |
国家食品药品监督管理总局. 药物临床试验的生物统计学指导原则. 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. 中共中央办公厅, 国务院办公厅. 关于深化审评审批制度改革鼓励药品医疗器械创新的意见. 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. 国家食品药品监督管理总局. 国际多中心药物临床试验指南(试行). 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. 国家食品药品监督管理总局. 药物临床试验的生物统计学指导原则. 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.
