Statistical challenges in medical device trials

SHANGHAI – Li Wei, director for National Centre for Cardiovascular Diseases China and visiting professor at the Chinese University of Hong Kong, Expert Review for Clinical Trials, SFDA, will share his insights into the use of safety and efficacy evaluation methods for medical devices from the statistics perspective, which will help type III medical device manufacturers to gain the latest device trial evaluation guidance during the 3rd Annual Implantable and Interventional Medical Devices (IIMD) China Conference 2013, on 23-24 May in Shanghai.

Medical devices are any medical items that are neither a drug nor a biological product. In light of their different mechanisms, actions and regulatory requirements, medical device (MD) trail evaluations are much more complicated than drug trails due to their unique clinical practices. Currently, the EMEA only evaluates MD safety instead of evaluating both safety and efficacy (which is left to the market), whilst the US FDA and the SFDA evaluate MDs for both safety and efficacy (510K). In this case, is the process for evaluating MD safety and efficacy using the same statistical principles as drugs?

Based on the unique features of medical devices, in such trials, the statistical inferences may carry a lower level of scientific assurance. How to smooth the impact of the potential biases? Big challenges exist to minimize bias from several sources, including:

- Operator selection bias

- Patient selection bias (demography of patients)

- Unblinding trial, evaluation bias

- OPC determination

- Agreement evaluation for diagnostic trial

There is an urgent need to develop specific guidelines for each kind of medical device in order to evaluate their efficacy and safety properly. MRBC has been involved into the guideline writings for SFDA (Type III) trials.

Also joining the IIMD China conference are Yang Ying, director of Lead Technology, CRM, MicroPort Medical; Yao Jianqing, PhD, senior director of Research and Development, Zimmer; Li Luming, chief professor, School of Aerospace, Tsinghua University, as well as Chen Chunlin, chief physician & professor, Obstetrics & Gynaecology, Department for Southern Medical University South Hospital and Guo Zhi, chief physician & professor, Interventional TherNike Sportswear