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Study points to need for more training in clinical trial design in China

July 2, 2009

A survey of more than 3,000 randomized clinical trials published in Chinese journals suggests that less than 10 per cent are actually randomized according to accepted guidelines. The survey, published in BioMed Central’s open access journal, Trials, was led by Dr. David Moher of Ottawa, Canada and Dr. Taixiang Wu of Sichuan, China.

“When done properly, randomization ensures that each participant who enrolls in a clinical trial has an equal chance of being allocated to each of the treatment groups,” said Dr. Moher, Senior Scientist at the Ottawa Hospital Research Institute (OHRI) and Associate Professor of Medicine at the University of Ottawa. “Improper randomization can result in biased results which can lead to the adoption of inappropriate medical practices. Our finding of poor randomization in many Chinese trials is quite serious. It could affect health care not only in China, but also around the world, because the results of these trials are often included in international medical reviews.”

The survey included trials in 20 common disease areas, published between 1994 and 2005 in peer-reviewed Chinese journals. About three quarters of the clinical trial authors (total 2235) were successfully contacted and agreed to participate in a brief survey. Interviews revealed that only 207 authors (9.3 per cent) fully understood and followed the principles of randomization, while 115 authors (5.1 per cent) understood the principles but did not follow them and 1913 (86 per cent) lacked a full understanding of randomization.

“Our results point to the need for more clinical research training in China, but there are already many promising signs on this front and this study is one of them,” said Wu, a clinical trial expert and Associate Professor at the West China Hospital, Sichuan University. “It is also important to note that a large amount of Chinese clinical research is published in non-Chinese journals and it is unlikely that these studies would have randomization problems.”

In recent years, Chinese researchers have established a number of clinical research and training initiatives, including the Chinese Cochrane Centre, the Chinese Evidence-based Medicine Centre and a Local Resource and Training Centre affiliated with the International Clinical Epidemiology Network. Dr. Wu is involved with all of these initiatives. Dr. Moher is involved with sister organizations in Canada, including the Canadian Cochrane Centre and Network and the University of Ottawa Evidence-based Practice Centre. Drs. Moher and Wu are planning future collaborative studies to promote best practices for clinical research in China and around the world.

This study was funded by the Chinese Medical Board of New York. The full text is available here.

About the Ottawa Hospital Research Institute
The Ottawa Hospital Research Institute (OHRI) is the research arm of The Ottawa Hospital and is affiliated institute of the University of Ottawa, closely associated with the University’s Faculties of Medicine and Health Sciences. The OHRI includes more than 1,300 scientists, clinical investigators, graduate students, postdoctoral fellows and staff conducting research to improve the understanding, prevention, diagnosis and treatment of human disease. www.ohri.ca

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