Sep 30, 2021
Video:Comparison of the CDE Guidance and the FDA Guidance
In recent years, there has been a noticeable increase in clinical trials of anticancer drugs in China.
Specifically, imaging endpoints derived from medical imaging assessments as surrogate endpoints are being chosen for more clinical trials.
In January 2021, the Centre for Drug Evaluation of China, the CDE, published guidance for the imaging endpoint process, especially focusing on antitumor clinical trials.
In this video, we compare the content of the China’s CDE guidance with Clinical Trial Imaging Endpoint Process Standards: Guidance for Industry, the U.S. FDA guidance. It will mainly provide an introduction of the similar considerations and differences between the two.