中国试验记录在世界卫生组织主要登记处的伦理审查报告。

Ethical review reporting of Chinese trials records in WHO primary registries.

机构信息

Chinese Evidence-Based Medicine Center, West China Hospital of Sichuan University, Chengdu 610041, China.

出版信息

J Med Ethics. 2011 Mar;37(3):144-8. doi: 10.1136/jme.2010.036558. Epub 2010 Nov 25.

DOI:10.1136/jme.2010.036558

PMID:21109699

Abstract

OBJECTIVE

To investigate the report rate of ethical review in registered Chinese trials records.

METHODS

Chinese trials recorded in WHO primary registries and http://clinicaltrials.gov to 14 July 2009 were identified. The report rates of ethical review and each of the 20 items in WHO's Trial Registration Data Set were calculated. Correlation of the item's report rate with the ethical review report rate was assessed. PubMed, EMBASE, CNKI and CBM (from the establishment of each database to 14 July 2009) were also searched to collect the full texts of completed trials to calculate the report rate of ethical review in the result publications.

RESULTS

A total of 1247 records were identified, and 687 (55.1%) reported ethical review. The records reporting secondary sponsor(s), contact for public queries and key secondary outcomes were more likely to report ethical review information (66.3% vs 44.3%, 38.1% vs 28.5%, 53.9% vs 51.8%). The ethical review report rate of trials sponsored by industry was lower than those sponsored by non-industry (40.9% vs 51.9%). The report rates of ethical review for self-supported trials (83.5%) and trials with unidentified sources of monetary or material support (66.7%) were lower than the average ethical review report rate for records in the Chinese Clinical Trial Registration Center (ChiCTR). The ethical review report rate was not high in the result publications (84.3% in http://clinicaltrials.gov, 50.0% in ChiCTR).

CONCLUSION

Registered Chinese trials records report ethical review inadequately. Incomplete registration is correlated with not reporting ethical review. Medical journals should inspect ethical review more critically.

摘要

目的

调查已注册的中国临床试验记录中伦理审查报告率。

方法

检索世界卫生组织一级注册机构和 http://clinicaltrials.gov 中 2009 年 7 月 14 日以前登记的中国临床试验，计算伦理审查报告率及世界卫生组织临床试验注册数据集中 20 个项目的报告率，评估各项目报告率与伦理审查报告率的相关性。还检索了 PubMed、EMBASE、中国知网（CNKI）和中国生物医学文献数据库（CBM）（各数据库建库至 2009 年 7 月 14 日）以收集完成试验的全文，计算结果出版物中的伦理审查报告率。

结果

共检索到 1247 条记录，其中 687 条（55.1%）报告了伦理审查。报告次要资助者、公共查询联系人及主要次要结局的记录更可能报告伦理审查信息（66.3%比 44.3%，38.1%比 28.5%，53.9%比 51.8%）。工业资助的试验的伦理审查报告率低于非工业资助的试验（40.9%比 51.9%）。自筹资金试验（83.5%）和来源不明的资金或物质支持试验（66.7%）的伦理审查报告率低于中国临床试验注册中心（ChiCTR）记录的平均伦理审查报告率。结果出版物中的伦理审查报告率也不高（http://clinicaltrials.gov 为 84.3%，ChiCTR 为 50.0%）。