Clinical Study Data Manipulation

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This information continues to support the conflict of interest existing within the clinical trials arena, and reinforces the importance of training personnel in ethics.

Study Finds Altering of Data for Diovan in Japanese ResearchData employed in a clinical study on Novartis Pharama K.K.’s blockbuster blood pressure lowering drug Diovan were found to be manipulated, the Kyoto Prefectural University of Medicine announced Thursday.

BMS & PPD Staff Cited by FDA for Manipulating Study DataDocuments released by the FDA disclose that the blood-thinning drug Eliquis was examined closely before approval, because a whistle-blower working for PPD implicated BMS and PPD in data manipulation at a study site in China. The drug is now sold by Bristol-Myers Squibb and Pfizer, after the FDA determined that the fraud that took place at a single site in China was not sufficient to compromise the quality of the overall data package.