Data-Monitoring Committees in China

• Activity Number: 647
• Type: Contributed
• Date/Time: Thursday, August 8, 2013 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Kent Koprowicz and Tingting Li*+ and Xiaohui Huang and Ping Xu
• Companies: Axio Research LLC and Axio Research and Axio Research and Axio Research Coporation
• Keywords: DMC ; DSMB ; Clinical Trials ; China ; Data Monitoring

Abstract

Data monitoring Committees (DMCs), also known as Data and Safety Monitoring Boards (DSMBs) are commonly used in clinical trials where major health outcomes are expected (e.g. death, progression of disease). DMCs periodically review interim data while a trial is ongoing in an effort to ensure the ethical conduct and scientific integrity of the study. DMCs have been an important component of government and industry sponsored US and European trials for decades. While there has been a large increase of clinical research in China and other Asian countries, the use of DMCs remains novel. We have served as the independent statistical group for several DMCs monitoring oncology trials conducted mainly in China. We share our experience of working with China-based DMCs. We describe the statistical methods employed for interim monitoring (descriptive, survival analysis, group sequential). We also explore the challenges for data monitoring in China in regard to constituting and implementing government guidelines, educating local DMC members on responsibilities and process, and meeting planning and logistics.