Clinical Trials Data Standards Steering Committee (CTDS-SC) Established within China FDA in Beijing on 19 June 2013
On 19 June 2013, the China Clinical Trial Data Standards Steering Committee (CTDS-SC) was established after a half- day workshop on data standards in Beijing. This committee was initiated by the Center for Drug Evaluation (CDE) of China FDA with the assistance from China CDISC Coordinating Committee (C3C). The committee consists of five members from C3C (led by Chair, Dr. Zibao Zhang), 6 officials from the CDE and over 10 experts from different areas in clinical trials (including data management, statistics and clinical), industry, academia and well-known hospitals. During the workshop, several committee members shared their experiences in the use of CDISC standards in their daily work. Dr. Zhang also took the opportunity to introduce CDISC data standards as well as the history and current status of C3C in China. Dr. Qin Huang (Deputy Director, Office of Biostatistics, CDE) recommended that a standards working group be set up under the steering committee, and listed some topics for discussion.
The purpose of the Steering Committee is to advocate for the data standards in clinical trials in China, advise the working groups and provide policy recommendation to China FDA based on the working groups’ technical input. According to the committee, CDISC Standards are the ideal data standards to use for clinical trials in China. The main issue is the fact that both the reviewers from CDE and industry clinical trials practitioners, including academics and hospitals, are not familiar with CDISC standards. In addition, CDISC standards do not cover Traditional Chinese Medicines (TCM) clinical trials.
The Steering Committee set some initial goals for the working groups for the 2nd half year of 2013 and 2014 including: 1) Chinese translation of latest CDISC foundational standards; 2) at least one pilot study to test the Chinese version; and 3) technical recommendations for data standards in China.
Five CTDS Working Groups (CTDS-WG) – on CDASH, SDTM, ADaM, Controlled Terminology and TCM– have been formed,mainly by the C3C. These working groups will focus on the translation of CDISC standards as well as a pilot study in Chinese, and may provide training as needed. The TCM working group will work with other TCM groups and professionals in China to develop CDISC data standards for TCM.
All these working groups are actively recruiting newmembers. Anyone who is interested in joining any of these groups and who would contribute their time and experience to Chinese CDISC clinical data standards, please contact us at
CDISCChina@cdisc.org.
Sheila Leaman CDISC, Director of Membership
Strength through Collaboration
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