Newsletter - September 29, 2016
Should FDA Accept Data From Clinical Trials Conducted in China?
This week the Chinese FDA announced results of its year-long investigation into clinical trials conducted in China, and the results were appalling. But its impact on Chinese manufactured drugs sold in the US is likely minimal, at least in the near future. Chinese auditors found that more than 80% of clinical trials contained fabricated and fraudulent data, omission of adverse events, incomplete or missing source documents, and many other egregious findings. Read More
Companies Do Not Publish All Adverse Events from Sponsored Clinical Trials
An analysis of published and unpublished adverse events reports from clinical trials shows that much of the adverse event data is not published in peer-reviewed journals. The authors concluded that peer-reviewed journals are not a reliable source for all adverse events identified for a given drug. The authors recommended that interested parties should look at other sources for complete adverse event data, such as presentations at conference or approaching the sponsor for complete clinical study reports. Read More..
Should FDA Accept Data From Clinical Trials Conducted in China?
This week the Chinese FDA announced results of its year-long investigation into clinical trials conducted in China, and the results were appalling. But its impact on Chinese manufactured drugs sold in the US is likely minimal, at least in the near future. Chinese auditors found that more than 80% of clinical trials contained fabricated and fraudulent data, omission of adverse events, incomplete or missing source documents, and many other egregious findings. Read More
Companies Do Not Publish All Adverse Events from Sponsored Clinical Trials
An analysis of published and unpublished adverse events reports from clinical trials shows that much of the adverse event data is not published in peer-reviewed journals. The authors concluded that peer-reviewed journals are not a reliable source for all adverse events identified for a given drug. The authors recommended that interested parties should look at other sources for complete adverse event data, such as presentations at conference or approaching the sponsor for complete clinical study reports. Read More..
