Symposium of Medical Data Analysis Committee, China Association for Medical Devices Industry (CAMDI) – Seminar on Statistic Design for Clinical Trials of Innovative Devices and University Data Management Course Setting
In order to standardize statistic design for clinical trials of innovative devices and evaluation methods and reach a consensus, Professor Li Wei, chairman of the Medical Data Analysis Committee, China Association for Medical Devices Industry (CAMDI) and director of the Medical Statistics Department of the National Center for Cardiovascular Disease, opened a seminar of a number of Beijing-based review experts on clinical trials of medical devices at The Presidential Hotel Beijing on December 6, 2018. They conducted in-depth and detailed research on application of new methods in clinical trial design of innovative medical devices, such as Bayesian method, adaptive design and propensity scoring method.
In her opening remarks, Professor Li pointed out that when it comes to encouraging product innovation and speeding up the listing of innovative products, traditional statistical methods based on frequency theory can no longer meet the needs of clinical trials of innovative medical device. This is where the Bayesian method and adaptive design came into play, which has also attracted the attention of domestic and foreign regulatory authorities. The US FDA has issued relevant guidelines for Bayesian methods and adaptive design of clinical trials. And she hoped that experts in the industry will reach a consensus on the conditions, methods and evaluation of results, providing reference for the design and evaluation of clinical trials. Deputy Secretary-General Yang Xiaofang of CAMDI expressed her gratitude to the committee for its research on clinical trial statistics and data. She hoped that special committee can share research results in time and strengthen communication and collaboration with other committees and members. As a result, scientific research results in clinical trials of medical devices can be put into practical use as soon as possible, as a way to promote the development of the industry.
During the seminar, associate professor Wang Yang from the Medical Statistics Department of the National Center for Cardiovascular Disease explained the basic ideas and results of Bayesian clinical trial design. In addition, she also proposed some problems for discussion. Yu Yongpei, an expert from the Peking University First Hospital introduced how to achieve Bayesian method using SAS software and emphasized the precautions in the process. Prof. Yao Chen from Peking University First Hospital detailed issues related to the adaptive design of clinical trials for medical devices, and emphasized the expansion and correction of Class I errors (false positive errors) in clinical trials of adaptive design. Experts have discussed and agreed on the preconditions for the application of Bayesian methods in clinical trials of medical devices and correction of Class I errors (α) in those of adaptive design.
The seminar also witnessed an in–depth discussion on how to improve the quality of management courses of clinical trial data and optimize such courses. Li Xiaomeng, IT Director of the Medical Statistics Department of the National Center for Cardiovascular Disease, first summarized the situation of the management course for clinical trial data of the master and doctor degree candidates from Peking Union Medical College, Chinese Academy of Medical Sciences and briefed the major problems reflected by the students. Professor Kang Xiaoping, from Peking University Health Science Center, and Dr. Fu Haijun, Chairman and CEO of Shanghai Zenith Medical Tech. Co., Ltd., had a heated discussion on relevant matters and put forward many innovative suggestions. At the end of the seminar, experts involved in the meeting suggested that more communication meetings should be opened in the future.