Chinese Journal of Evidence-Based Medicine, Periodical Press of West China Hospital of Sichuan University, Chinese Evidence-Based Medicine/Cochrane Center, Chengdu 610041, China.
J Evid Based Med. 2009 Feb;2(1):8-18. doi: 10.1111/j.1756-5391.2009.01007.x.
To evaluate the quality of the registration information for trials sponsored by China registered in the WHO primary registries or other registries that meet the requirements of the International Committee of Medical Journal Editors (ICMJE).
We assessed the registration information for trials registered in the 9 WHO primary registries and one other registry that met the requirements of ICJME as of 15 October 2008. We analyzed the trial registration data set in each registry and assessed the registration quality against the WHO Trial Registration Data Set (TRDS). We also evaluated the quality of the information in the Source(s) of Monetary or Material Support section, using a specially prepared scale.
The entries in four registries met the 20 items of the WHO TRDS. These were the Chinese Clinical Trial Registration Center (ChiCR), Australian New Zealand Clinical Trials Registry (NZCTR), Clinical Trials Registry - India (CTRI), and Sri Lanka Clinical Trials Registry (SLCTR). Registration quality varied among the different registries. For example, using the Scale of TRDS, the NZCTR scored a median of 19 points, ChiCTR (median = 18 points), ISRCTN.org (median = 17 points), and Clinical trials.org (median = 12 points). The data on monetary or material support for ChiCTR and ISRCTN.org were relatively complete and the score on our Scale for the Completeness of Funding Registration Quality ranged from ChiCTR (median = 7 points), ISRCTN.org (median = 6 points), NZCTR (median = 3 points) to clinicaltrials.gov (median = 2 points).
Further improvements are needed in both the quantity and quality of trial registration. This could be achieved by full completion of the 20 items of the WHO TRDS. Future research should assess ways to ensure the quality and scope of research registration and the role of mandatory registration of funded research.
评价在中国注册登记、并在世界卫生组织（WHO）一级注册机构或符合国际医学期刊编辑委员会（ICMJE）要求的其他注册机构登记的由中国资助的临床试验的注册信息质量。
我们评估了截至 2008 年 10 月 15 日在 9 个 WHO 一级注册机构和 1 个符合 ICMJE 要求的其他注册机构登记的临床试验的注册信息。我们分析了各注册机构的试验注册数据集，并根据 WHO 临床试验注册数据集（TRDS）评估了注册质量。我们还使用专门编制的量表评估了“资金来源”部分的信息质量。
有 4 个注册机构的条目符合 WHO TRDS 的 20 项要求，这 4 个注册机构是中国临床试验注册中心（ChiCR）、澳大利亚和新西兰临床试验注册中心（NZCTR）、印度临床试验注册中心（CTRI）和斯里兰卡临床试验注册中心（SLCTR）。不同注册机构的注册质量存在差异。例如，使用 TRDS 量表，NZCTR 的中位数评分为 19 分，ChiCTR（中位数=18 分）、ISRCTN.org（中位数=17 分）和 Clinicaltrials.org（中位数=12 分）。ChiCTR 和 ISRCTN.org 的资金或物质支持数据相对完整，我们的“资金注册质量完整性量表”评分范围为 ChiCTR（中位数=7 分）、ISRCTN.org（中位数=6 分）、NZCTR（中位数=3 分）和 clinicaltrials.gov（中位数=2 分）。
需要进一步提高临床试验注册的数量和质量。这可以通过完整填写 WHO TRDS 的 20 项内容来实现。未来的研究应评估确保研究注册质量和范围的方法，以及对资助研究进行强制性注册的作用。
