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Tribute to the third anniversary | Interpretation of academician expert report: Development and Prospect of Clinical Trial Biostatistics in China by P

Source:DUZHENG  Release date:2019-03-26



On January 12, 2019, the “Biomedical Industry Development Summit” of the Third Anniversary Celebration of Duxact invited Professor Su Binghua, Founder of China’s Statistics to give a special report.

The following is a brief interpretation of Professor Su’s report:

Development history of clinical trial biostatistics in China

As “a leader of clinical trial biostatistics in China,” Professor Su systematically reviewed the background, drafting and finalizing process of China's main regulations and policies on clinical trials as well as biostatistics-related guiding principles, based on his own education and work experience:

In the 1990s, China had neither clinical trial quality management specifications nor clinical trial statistics specifications. To this end, Professor Su visited the UK twice for study. After returning to China, he resolutely joined the Expert Panel of Clinical Trial Statistics set up by the Bureau of Pharmaceutical Affairs (药政处) of former Ministry of Health. He was responsible for studying the statistical guidelines of western clinical trials, and formulated the guiding principles of clinical trial biostatistics according to China’s national situation.

In 1998, the National Medical Products Administration (国家药品监督管理局) was officially established, and the Drafting Group of Clinical Trial Statistics was established. After more than seven years of research, discussion, finalization and trial operation, the Guiding Principle of Biostatistical Techniques for Clinical Trials of Chemical Drugs and Biological Products was officially promulgated in March 2005. This Guiding Principle greatly enhances the application of biostatistics in clinical trials and improves the quality of clinical trials.

With the development of international clinical trials and the improvement of domestic drug R&D level, the Center for Drug Evaluation (药品审评中心) initiated the revision of the Guiding Principle in 2012. After more than three years of research and expert discussions, the former China Food and Drug Administration officially published the Guiding Principle of Biostatistics for Clinical Trials of Drugs in June 2016. In order to standardize the management of clinical trial data and ensure the authenticity, integrity and standardization of the data, the Technical Guides for Clinical Trial Data Management, Technical Guidelines for Electronic Data Collection (EDC) of Clinical Trials and Guiding Principle for Planning and Reporting of Data Management and Statistical Analysis of Drug Clinical Trials were introduced in July 2016.

In recent years, the Center for Drug Evaluation (药品审评中心) has further clarified the functions of statistics in scientific supervision and review. At the end of 2010, the Center set up the Department of Biostatistics, which is mainly responsible for the biostatistics review of various drugs, and provides technical support for the review of related professions.


At the forum, Professor Su put forward three passionate hopes for the discipline development as a pioneer in clinical trial statistics:

(1) The Panel of Clinical Trial Biostatistics in China needs to be expanded, recommended and cultivated; the Biostatistics Panel should work to resolve various statistical issues and reach the consensus;

(2) The Data Management Panel of Clinical Trials in China should meet the needs of clinical trial development, promote the professionalization and standardization construction of data management, and improve the data management level of clinical trials in China;

(3) The Medical Statistics Professional Committee of China Medicine Education Association (中国医药教育协会医药统计专业委员会) should unite the statistical professionals in the field of medicine to contribute to medical education and training, academic exchange, research and development, application transformation, professional services and decision support, etc., thus providing a strong guarantee of statistical methodology for the vigorous development of China’s pharmaceutical industry.

“I am a thick book about clinical trial biostatistics, and anyone can open it when needed.” Professor Su witnessed the history of biostatistics from scratch. The future has come and domestic statistical experts must not disappoint the hopes of the pioneers, walk hand in hand, and strive to make the development of clinical trial biostatistics in China enter into the forefront of the world.

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