FDA to tighten oversight of foreign clinical trial sites as China trial volume soars

FDA officials wrote an editorial stating that inspection access is not an administrative footnote and announced plans to expand oversight of foreign clinical trial sites.

The initiative follows three deaths in separate gene therapy trials in China, leading U.S. lawmakers to urge the FDA to reject Chinese data unless sites have recent FDA audits.

The agency will add resources, improve communication with sponsors, and strengthen reviewer training to identify sites of concern, as China’s share of global trials has risen sharply, overtaking the U.S. by 2020.