Prof. Li, as one of the earliest professionals in China who work on GCP, has been engaged in anti-cancer drugs clinical research and the work of the Ethic Committee since 1996. Thanks to the working experience of nearly 20 years in the field she is very knowledgeable with the regulations and laws regarding clinical trials, and has a good mastery of the requirements and procedures, both China’s and international, in new drugs clinical trials. She drafted EC Regulations with Chinese characteristics, which is considered the first in China. She has drafted various standard operating procedures (35 SOPs, about 140,000 words), reviewed about 600 clinical trial protocols and informed consent forms, including those for chemical drugs, biological agents, traditional Chinese drugs, In vitro diagnostic reagents as well as medical devices. She has also drafted 9 Phase I IND trial protocols, informed consent forms and investigators’ brochures, and participated in the designing of 100 IND protocols. As a routine work she reviews more than 200 protocols and informed consent forms per year. In 2011 she initiated and also organized the International Ethics Review Seminar at which a platform for communication between ECs was primarily established.
As one of the chief participants, she worked on the State projects of the 9th 5-year, the 10th 5-year and 11th 5-year Programs of “The Construction of the Platform (GCP) for Anti-Cancer Drugs Clinical Research”. She has more than 20 papers published in China’ kernel journals and as a co-author written or composed 4 books. In addition, she is also a member of the State Ethics Experts Consulting Committee and a member of DIA Advisory Committee of China.