The vast bulk of studies published as randomised clinical trials (RCTs) in Chinese medical journals do not live up to that description, a new analysis has concluded. This does not, however, apply to pre-market RCTs for pharmaceuticals, all of which were found to be authentic.

Researchers led by Taixiang Wu of the Chinese Cochrane Centre at Sichuan University looked at 3,137 studies identified by their authors as randomised controlled trials out of an initial sample of 37,313 articles selected from the China National Knowledge infrastructure database. The studies involved 20 common diseases and were published in Chinese journals between January 1994 and June 2005.

As the authors pointed out in BioMed Central’s open-access journal Trials, the 1,100 or so medical journals now active in China publish a rapidly growing number of research reports, including a number of studies claiming to be RCTs. “It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question,” Wu et al commented.

Of the 3,137 so-called RCTs, 1,452 involved conventional medicine (CM) and 1,685 traditional Chinese medicine (TCM). Interviews with the authors revealed that only 207 of the studies (6.6%) adhered to accepted methodology for randomisation and as such could be deemed authentic RCTs, the researchers reported.

There was no statistically significant difference between the proportion of authentic trials involving conventional and traditional Chinese medicine. However, only five trials apiece in the COM and TCM categories were of drugs for marketing approval purposes, and all of these were found to be authentic RCTs.

The reason, the authors explained, was that “the performance of any trial for a pre-market drug must be registered and approved by the Chinese State Food and Drug Administration (SDFA), which releases licences only for those clinical trials that are designed according to good clinical practice guidelines”.

Addressing the low level of these trials in the sample, the researchers hypothesised that “most real RCTs or high-quality studies were published in international journals, and most pre-market drug clinical trials had not been published due to the fact that the priority purpose of conducting a clinical trial for drug makers is to get approval from the SDFA, rather than publishing the results”.

It is estimated that 1,250 applications for clinical trials and drug approvals are filed in China every month, so “most trials of pre-market drugs were not published in Chinese journals”, they added.

Across the whole of the sample, randomised controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic (18.7%) than those conducted at level three (11.8%) or two (1.3%) hospitals. Moreover, 51.6% of studies supported by government and other official organisations were regarded as authentic RCTs.

On a general note, Wu et al observed that studies identified as RCTs are more likely to influence health policymakers, meaning that falsely reported randomised controlled trials have the potential to mislead these policymakers as well as healthcare providers and consumers.

“Education regarding both methodology and social responsibility for healthcare providers who are potential authors of research articles is urgently needed in China,” they stated.