Troubled by false clinical data, China seeks improvement

By Wang Fangqing

China must take measures to largely improve its clinical data quality to be a competitive player in the global biotech market, said speakers at China’s recent clinical development summit held in Shanghai, reports The Pharma Letter’s local correspondent Wang Fangqing.

“Clinical trial data quality is the bottleneck for China’s drug innovation. This is how critical it is,” said Yan Hui, senior vice president at the Shanghai-based CRO dMed and a veteran of China regulatory affairs. In January 2018, her former employer RDPAC, the Beijing-based lobbying organization for multinationals in China, published a report that analyzes China’s clinical study quality including clinical study design and standard operating procedures (SOP).