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PLoS One. 2010 Sep 13;5(9):e12676. doi: 10.1371/journal.pone.0012676.

Result publication of Chinese trials in World Health Organization primary registries.

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1
Chinese Journal of Evidence-Based Medicine, West China Periodicals Press, West China Hospital of Sichuan University, Chengdu, China.

Abstract

BACKGROUND:

Result publication is the key step to improve the transparency of clinical trials.

OBJECTIVE:

To investigate the result publication rate of Chinese trials registered in World Health Organization (WHO) primary registries.

METHOD:

We searched 11 WHO primary registries for Chinese trials records. The progress of each trial was analyzed. We searched for the full texts of result publications cited in the registration records. For completed trials without citations, we searched PubMed, Embase, Chinese Biomedical Literature Database (Chinese), China Knowledge Resource Integrated Database, and Chinese Science and Technology Periodicals Database for result publications. The search was conducted on July 14, 2009. We also called the investigators of completed trials to ask about results publication.

RESULTS:

We identified 1294 Chinese trials records (428 in ChiCTR,743 in clinicaltrials.gov,55 in ISRCTN, 21 in ACTRN). A total of 443 trials had been completed. The publication rate of the Chinese trials in WHO primary registries is 35.2% (156/443).The publication rate of Chinese trials in clinicaltrials.gov, ChiCTR, ISRCTN, and ACRTN was 36.5% (53/145), 36.3% (89/245), 26.0% (9/44), and 55.6% (5/9), respectively. The publication rate of trials sponsored by industry (23.8%) was lower than that of sponsored by central and local government (31.7%), hospital (35.1%), and universities (40.7%). The publication rate for randomized trials was higher than that of cohort study and case-control study (33.2% versus 16.7%, 22.2%). The publication rate for interventional studies and observational studies was similar (33.4% versus 33.3%).

CONCLUSION:

The publication rate of the registered Chinese trials was low, with no significant difference between ChiCTR and clinicaltrials.gov. An effective mechanism is needed to promote publication of results for registered trials in China.

PMID:
20856888
PMCID:
PMC2938364
DOI:
10.1371/journal.pone.0012676
[Indexed for MEDLINE]
Free PMC Article
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