cGMPs

In-House Probe on Falsified Novartis Clinical Trial Data Insufficient

Source: PharmaManufacturing.com

Jul 15, 2013

the-japan-news.com

Although the Kyoto Prefectural University of Medicine has concluded that clinical research data on a high blood pressure drug were falsified, it remains unclear whether a former employee of the maker of the drug was involved in manipulating the information.

The falsification of the data concerning the drug Diovan, sold by Novartis Pharma K.K., betrayed the hopes of many patients. Observers are calling for a thorough examination of the case. In its report on its internal investigation, the university pointed to “the possibility that manipulation occurred during the process of compiling analysis data.” But it also said the data could have been tampered with after they were brought to the cardiovascular and internal medicine department. Read more