NMPA Research Base for Drug and Medical Device Regulatory Science Hainan Institute of Real World Data
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2022.05 24
Opinion: Contrary to what the FDA says, Chinese regulators do care about clinical data integrity
Editor’s note: The FDA recently cited a report saying that “80% of clinical trial data from China were ‘fraudulent or substandard’.” Yao argued that the view is outdated ...
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2022.05 24
Protecting the accuracy of clinical trial data in China
The Chinese government has signalled its commitment to ensuring the quality of clinical trials conducted in China. In 2015, the China Food and Drug Administration (CFDA) announced a plan to protect da...
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2022.03 21
Opinion: Contrary to what the FDA says, Chinese regulators do care about clinical data integrity
By Yao ChenEditor’s note: The FDA recently cited a report saying that “80% of clinical trial data from China were ‘fraudulent or substandard’.” Yao argued that the view i...
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2022.02 28
Suitable Study Design and Statistical Analysis Methods for Real-World Study of Licensed Medical Devices in Lecheng
Cite this articleCao Han, Yao Chen*, Yan Xiaoyan, Yu Yongpei, Shang Meixia. Exploration of Design Types and Statistical Analysis Methods of Licensed Medical Device Clinical Research Based on Boao Lec...
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2022.02 28
You Can’t Miss this Special Issue if You Wish to Learn about Latest Theory and Practice Achievements of Real-world Study
Features at a glanceIn the 11th issue of 2021, the magazine "China Food and Drug Administration" and the Hainan Real World Data Research Institute jointly set up a special issue on "Rea...
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2022.02 28
First Conference on Real-world Studies/ Sun Xin: Real-world Studies Promote Lecheng into a Highland of Drug Innovation and Talent Aggregation
The first Boao International Conference on Real-world Studies of Medical Products (the first Conference on Real-world Studies) will be held on December 6-7, 2021. As the event is around the corner, we...
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