Trials, a journal brought out by open access publisher BioMed Central, UK, has published a study questioning the authenticity of randomised controlled trials (RCTs) published in Chinese journals. The study says that more than 90 percent of a sample of RCTs published in these journals between 1994 and 2005 did not adhere to recognised methodology for randomisation. This is seen to cast doubts on the reliability of research that has the potential to influence medical decision-makers.
The study was carried out by Taixiang Wu and colleagues of the Chinese Cochrane Centre at Sichuan University, China and Ottawa Hospital Research Institute. They searched the China National Knowledge Infrastructure electronic database for reports published in Chinese literature during the study period that were described by the authors as RCTs or claimed to have used random sequence generation or allocation concealment.
Telephone interviews with the first or co-authors of 2,235 reports about randomisation methods and quality-control features of the trial indicated that only 6.8 percent of the studies be considered 'authentic' RCTs. Although only 51.6 percent of trials supported by government or other official organisations were found to be authentic, all trials of pre-market drugs were identified as such. Wu et al. report that of the first-authors erroneously identifying their studies as RCTs, 85.6 percent did not fully understand the principles of randomisation, whilst 5.1 percent mislabelled their trials despite an understanding of the relevant methodology.
The misleading reporting of RCTs is likely a worldwide problem, but the investigators suggest a link between their results and the high proportion of positive trial results published in Chinese journals. The investigators also note that inadequate randomisation has been previously shown to result in more favourable estimates of treatment effects. They also highlight the potential for falsely reported RCTs to mislead healthcare providers and policy makers, and impact upon the findings of systematic reviews.
Wu et al. advocate improvements to the education of researchers in the principles of randomisation methodology and scientific reporting. In addition, they suggest that the development of peer review guidelines is needed to help identify poorly randomised studies before publication.
The study is available online at http://www.trialsjournal.com/content/10/1/46.
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