Ex-Aptuit Employee Busted for Clinical Trial Data Scam
April 22nd, 2013 // 2:05 pm @ jmpickett
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Late last week, a former employee of the Aptuit clinical research organization was sentenced to three months in jail for 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.
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As we reported last month, 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 data that was 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 to significant development delays for a “number of new medicines” and “considerable cost to the study sponsors was incurred,” according to a statement from the MHRA. Aptuit had reviewed 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.
“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. The sentence 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 said in the statement.
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