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|National Institutes of Health, USA|
|ScientificTracks Abstracts: J Clin Trials|
|As the rising economic superpower in the world, China is now striving to be at the forefront of clinical research and drug development. There are many advantages to conducting clinical trials in China including large patient populations, a large and growing network of hospitals qualified to conduct high standard clinical trials, skilled clinical trial and laboratory professionals and project leaders, strong support from the government for international partnerships, improved regulatory environment for clinical trials and new drug approval, and strong enthusiasm for international collaborations. However, several challenges remain, such as large migrant populations, language and cultural differences, and the uncontrolled use of traditional Chinese medicine. Timely importation of study agents is one other significant challenge. Quality control is the key to ensure clinical research projects meet the highest standards. The recent changing drug regulatory landscapes have also brought attention and galvanized international companies that intend to conduct drug trials in China. This workshop, using the real examples, will present and discuss the advantages and challenges of conducting clinical trials in China. The pitfalls to avoid and possible solutions to conducting high quality clinical trials in China will be emphasized.|
Jing Bao is a Medical Officer at the division of AIDS, National Institute of Allergy and Infectious Diseases, Columbus Technologies and Services, Inc. with extensive experience in international clinical trial oversight and global regulations. She manages and oversees the US government (National Institutes of Health) funded/ sponsored international multi-center clinical trials on treatment development for HIV/AIDS and co-infections. She received her MD from China and was a Medical Director for two hospitals before she received a PhD from Israel. She has published influential research findings in world leading journals. She is the Member of Asian American Executives Network and will be graduated from its Senior Executive Service Candidate Development Program in April 2017.
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