An assessment of the quality of randomised controlled trials conducted in China

Dalu Zhang¹ , Peng Yin¹ , Nick Freemantle² , Rachel Jordan¹ , Nanshan Zhong³ and KK Cheng¹

¹Department of Public Health and Epidemiology, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK

²Department of Primary Care and General Practice, Primary Care Clinical Sciences Building, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK

³Guangzhou Institute of Respiratory Diseases, First Affiliated Hospital, Guangzhou Medical College, Guangzhou 510120, China

author email corresponding author email

Trials 2008, 9:22doi:10.1186/1745-6215-9-22


Published:	24 April 2008

Abstract

Background

Despite the rapid increase in research in China, little is known about the quality of clinical trials conducted there.

Methods

A systematic review and critical appraisal of randomised controlled trials (RCTs) conducted in China and published in 2004 was undertaken to describe their characteristics, assess the quality of their reporting, and where possible, the quality of their conduct. Randomised controlled trials in all disease areas and types of interventions, which took place in China and included Chinese citizens were identified using PubMed and hand searching the Journal Series of the Chinese Medical Association. Quality was assessed against a subset of criteria adapted from the CONSORT statement.

Results

Three hundred and seven RCTs were included. One hundred and ninety-nine (64.8%) failed to report methods of randomization and 254 (82.4%) did not mention blinding of either participants or investigators. Reporting of baseline characteristics, primary outcome and length of follow-up was inadequate in a substantial proportion of studies. Fewer than 11% of RCTs mentioned ethical approval and only 18.0% adequately discussed informed consent. However, dropout rates were very favourable with nearly 44% of trials reporting a zero dropout rate.

Conclusion

Reporting of RCTs in China requires substantial improvement to meet the targets of the CONSORT statement. The conduct of Chinese RCTs cannot be directly inferred from the standard of reporting; however without good reporting the methods of the trials cannot be clearly ascertained.