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Novartis employees may have violated trial protocol in Japan
January 17, 2014 / 8:11 PM / 4 years ago

Novartis employees may have violated trial protocol in Japan

Jan 17 (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.”

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.

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