Novartis employees may have violated trial protocol in Japan

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[January 18, 2014]  (Reuters)  Swiss drugmaker Novartis said on Friday it was looking into a report that employees of is Japanese unit may have violated clinical trial protocol by handling data from a small independent study of one of its cancer drugs.

Employees of Novartis Pharma K.K. (NPKK) transferred some data from research centers to a Tokyo hospital when that data should have been sent directly without first passing through Novartis hands, according to a report by Japanese broadcaster NHK that was picked up by the Wall Street Journal.

"NPKK is currently investigating the allegations," Novartis said in a statement.

The data was from a not yet fully enrolled 55-patient trial testing the Novartis cancer drug Tasigna, the company said.

"Novartis Pharma K.K. is aware of the media report regarding a small investigator-initiated clinical study ... conducted to assess side effects in patients with chronic myelocytic leukemia," Novartis said in a statement.

"NPKK has conducted employee trainings on proper protocol related to investigator-initiated clinical studies and believes that any involvement of our medical representatives in investigator-initiated clinical studies is inappropriate."

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The University of Tokyo Hospital said it was re-examining test results it had received but had uncovered no evidence that Novartis employees had manipulated any of the data during the transfers, according to the Wall Street Journal report.

(Reporting by Bill Berkrot; editing by Andrea Ricci)

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