中国循证医学杂志

中国循证医学杂志

中国临床试验注册中心注册高血压临床试验的特征分析

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目的通过分析中国临床试验注册中心(ChiCTR)注册的高血压相关临床试验的特征,探讨高血压临床试验注册特点及发展趋势。方法检索 ChiCTR 数据库,搜集所有高血压相关临床试验,检索时限从建库至 2018 年 3 月 25 日。对注册临床试验的特征进行分析。结果共获得高血压相关临床试验 135 个。其中,北京、广东、江苏、重庆、上海五省(市)注册数量占总数的 55.5%。115 个试验的注册状态为预注册。经费来源前三位分别为地方财政(32 个,23.7%)、自筹经费(25 个,18.5%)和医院(20 个,14.8.%)。79 个随机对照试验中,55 个在盲法部分的填写为空白/缺失。结论ChiCTR 注册高血压相关临床试验数目呈递增趋势,但存在地区不均衡性。部分研究者在临床试验注册时存在资料填写不完整、不规范的情况。建议相关部门加大临床试验注册宣传,提高临床试验注册意识,促进高质量临床试验的开展。

ObjectivesTo analyze the metrological characteristics of hypertension-related clinical trials registered on Chinese Clinical Trial Registry (ChiCTR), and discuss the characteristics and developmental trends of hypertension clinical trials registration in China.MethodsChiCTR were searched to collect hypertension-related clinical trials from inception to March 25th, 2018. The characteristics of registered trials were analyzed.ResultsA total of 135 registered trials were included, in which the trials from Beijing, Guangdong, Jiangsu, Chongqing and Shanghai accounted for 55.5%. 115 trials were pre-registered. The top three funding sources were from finance (32, 23.7%), self-financing (25, 18.5%) and hospital (20, 14.8%), respectively. Of all 79 randomized controlled trials, 55 were blank/missing in the entry of blinding method.ConclusionsThe number of hypertension-related clinical trials in ChiCTR tends to increase, however there are large regional disparities and incomplete, non-standardiazed information in the registration of clinical trials. The relevant departments should increase the publicity on the registration of clinical trials, raise the awareness of registration, and promote the development and registration of high quality clinical trials.

关键词: 高血压; 临床试验; 中国临床试验注册中心

Key words: Hypertension; Clinical trials; Chinese Clinical Trial Registry

引用本文: 苏艳玲, 全柳柳, 杨梓钰, 廖晓阳, 李志超. 中国临床试验注册中心注册高血压临床试验的特征分析. 中国循证医学杂志, 2018, 18(10): 1114-1117. doi: 10.7507/1672-2531.201807122 复制

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1. WHO. Causes of Death. Geneva: World Health Organization, 2008. Available at: http://www.who.int/healthinfo/global_burden_disease/cod_2008_sources_methods.pdf.
2. Lim SS, Vos T, Flaxman AD, et al. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet, 2012, 380(9859): 2224-2260.
3. Lackland DT, Woolson RF. Clinical hypertension research tools: the randomized controlled clinical trial. J Clin Hypertens (Greenwich), 2006, 8(6): 427-431.
4. 吴泰相, 李幼平, 卞兆祥, 等. 中医药临床随机对照试验报告规范(征求意见稿). 中国循证医学杂志, 2007, 7(8): 601-605.
5. DeAngelis CD, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Arch Otolaryngol Head Neck Surg, 2005, 131(6): 479-480.
6. 曹莹莹, 林能明, 方罗. 中国临床试验注册中心在册药物临床试验分析. 中国药房, 2012, (41): 3858-3860.
7. Saito H, Gill CJ. How frequently do the results from completed US clinical trials enter the public domain?-A statistical analysis of the ClinicalTrials.gov database. PLoS One, 2014, 9(7): e101826.
8. Ross JS, Mulvey GK, Hines EM, et al. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Med, 2009, 6(9): e1000144.
9. Sniderman AD, LaChapelle KJ, Rachon NA, et al. The necessity for clinical reasoning in the era of evidence-based medicine. Mayo Clin Proc, 2013, 88(10): 1108-1114.
10. 詹思延. 随机化临床试验结果分析和解释的几个问题. 中华医学杂志, 2000, 80(6): 475-477.
11. 卢鹏飞, 廖星, 谢雁鸣, 等. 基于美国 ClinicalTrials.gov 分析中医药临床试验注册特点. 中国中西医结合杂志, 2015, 35(11): 1388-1392.
12. 吴泰相, 李幼平, 姚巡, 等. 实行临床试验注册制度, 提高我国临床研究质量. 中国循证医学杂志, 2006, 6(3): 153-156.
13. Zarin DA, Tse T, Williams RJ, et al. Trial Reporting in ClinicalTrials.gov - The Final Rule. N Engl J Med, 2016, 375(20): 1998-2004.
14. 邬兰, 田国祥, 王行环, 等. 临床试验的注册及注册平台比较分析. 中国循证心血管医学杂志, 2017, 9(2): 129-134.
15. 严恺, 李佳, 孔艳婷, 等. ClinicalTrials.gov 建库以来儿童临床试验注册现况横断面调查. 中国循证儿科杂志, 2016, 11(1): 3-7.