Why so many 'RCTs' were false? A further investiga­tion about ethics review status of the 'RCTs' published in Chinese journals

Article type
Authors
Wu T, Yang X, Zeng X
Abstract
Background: We have reported that only 7% (95% CI 5.9 to 7.7) of so-called RCTs published in Chinese journals are authentic. One of the main reasons is that most Chinese authors lack knowledge of trial design. Lack of ethics review is considered another important reason. Objective: To understand if the lack of ethics review is the reason why most RCTs published in Chinese journals are not true RCTs. Methods: We searched the CNKI database from 1980 to 2005, scanned the titles to include relevant articles and read through those trials that mentioned ethics review. Results: In 1989, the first trial that mentioned ethics review was published. 1166 trials out of 71,758 were ethics reviewed, the number of ethics reviewed trials increased over the years, the average percentage was 1.6% (Table 1). The percentages increased over time from 0% in 1980 to 2.8% in 2005. All ethics reviewed trials were pre-market drug studies. Discussion: All the ethics reviewed trials were pre-market drugs studies suggesting that: i) only pre-market drugs studies are ethics reviewed; ii) since it is reported that more than one thousand clinical trials of pre-market drugs are conducted monthly in China, most pre-market drug studies are not published in Chinese journals. There is a possibility that most trials that have been ethics reviewed are published in international journals. Conclusions: The percentage of ethics reviewed ‘RCTs’ published in Chinese journals from 1980 to 2005 was low. All ethics reviewed trials were pre-market drug studies. Lack of ethics review should be one of the most important factors of why most author claimed RCTs are false RCTs. Since most pre-market drug studies were not published in Chinese journals, the percentage of ethics reviewed trials may be lower than the real situation.