Objective To explore the methodological
quality of articles on
clinical drug therapeutic
trials in China. Methods All original articles on clinical drug therapeutic concurrent
controlled trials published in 18 Chinese Medical Series Journals from 1996 to 1998 were selected as objects of surveying. The questionaire formed was based on the Standards of Reporting Group and Downs' checklists for the assessment of the methodological quality of clinical controlled trials. Results Among all 220 investigated original articles, 29.1 % did not state the source of subjects, 73.2% used random allocation for data treatment and 16.8% used double-blind trials; 11.8% did not describe any prognostic characteristics and demographics at
baseline, 24.1% did not test the
statistical balance of important baseline variables between groups. In 220 papers, the maximum number of criteria for evaluation of therapeutic efficiency was 27, the median was 5.4; 17.7% reported the compliance of cases, the mistake rate of statistical inference about the main outcomes was 25.0%. The main factors which affected the reliability of study conclusion were in order as follows: Too small sample size (
occupied 30.0%); the mistake of statistical analysis (occupied 25.0%); and the unbalance of important baseline (occupied 15.9%) etc. Conclusions The quality of these articles on pharmaceutical therapeutic trials was considerably low to meet the requirement of systematic reviews. Thus, it is very necessary that the standards of clinical trial should be worked out and executed in order to improve the quality of clinical therapeutic trials in our country. <
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