Devicemakers planning to begin a clinical trial in China should expect the process to take an average of nine to 11 months, including the two months needed for translation and other preparation of the trial application. But the rapid patient recruitment typical of China can make up for the lengthy start-up period, Jenny Zhang, director of business development for Tigermed Consulting, said at a recent conference.
Conducting device trials in China can be simpler than drug trials with regard to good clinical practice and ethics committee approval. Zhang advised sponsors to plan ahead, communicate properly, conduct tailored training programs, and assemble a strong local operation team or partner and sufficient monitoring resources.