Ex-Aptuit Employee Busted for Data Scam

Ex-Aptuit Employee Busted for Data Scam

March 13th, 2013 // 2:54 pm @

How The Quality Manager Gets Fired!

A former employee of the Aptuit clinical research organization was found guilty of altering pre-clinical trial data that was used to support applications to perform clinical trials, according to the UK’s Medicines and Healthcare products Regulatory Agency. The MHRA noted this was the first instance in which Good Laboratory Practice Regulations were used to pursue such a prosecution.

The probe into Steven Eaton began when Aptuit identified serious irregularities in pre-clinical data and informed the agency. Dating back to 2003, he began selectively reporting used to assess whether analytical methods were working properly or to assess the concentration of the drug in blood. The data manipulation ensured an experiment was deemed successful, when it actually had failed, the MRHA notes.

His actions led Aptuit to review hundreds of safety studies assessing the impact of the manipulation and to ensure the compromised data was not used in future submissions to authorities without their knowledge, the MHRA says in a statement. As a result, the development of a number of new medicines were significantly delayed at considerable cost. However, the results of the affected trials were not invalidated.

How The Quality Manager Gets Fired!

“Mr. Eaton’s actions directly impacted on the validity of clinical trials and delayed a number of medicines coming to market, including one to treat depression. This conviction sends a message that we will not hesitate to prosecute those whose actions have the potential to harm public health,” Gerald Heddell, MHRA Director of Inspection, Enforcement and Standards, says in the statement. Eaton will be sentenced next month.

H/T: Pharmalot




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