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MHRA successfully prosecutes on preclinical data manipulation

Clinical News | March 14, 2013


Peter Mansell

MHRA successfully prosecutes on preclinical data manipulation

A former employee of US-based drug-development services company Aptuit has been successfully prosecuted by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for manipulating preclinical trial data.

This is the first time the MHRA has used the Good Laboratory Practice Regulations 1999 to bring a successful prosecution, the agency noted.

Steven Eaton was found guilty at Edinburgh Sheriff’s Court of altering preclinical trial data designed to support applications for clinical trials. Eaton will return to court for sentencing on 17 April 2013.

Aptuit used to run two Scottish facilities at Livingston and Riccarton near Edinburgh but announced in December 2010 that it was closing them down, citing the worldwide recession and pharmaceutical market dynamics.

Serious irregularities

It was Aptuit who informed the MHRA they had identified “serious irregularities” in preclinical data generated to support human clinical trials and the registration of new medicines, the agency said.

These irregularities involved “changing or providing false analytical data that would be used to determine the concentration of medicine that could be given to clinical trial subjects used to assess the safety and efficacy of a new medicine”.

The MHRA launched an investigation to identify the number of studies affected and the impact the irregularities would have on the interpretation of relevant safety data. It concluded that Eaton had selectively reported analytical data over a number of years, dating back to 2003.

This included data used to gauge whether analytical methods were working properly or to assess drug concentrations in blood, the MHRA reported. The data manipulation “ensured an experiment was deemed successful when in fact it had failed”.

Hundreds of studies

The investigation involved reviewing “many hundreds” of safety studies to determine the impact of the data manipulation and ensure that the compromised data were not “used in future submissions to relevant authorities without their knowledge”, the agency said.

The data manipulation meant the development of a number of new medicines was significantly delayed, at considerable cost to the study sponsors, it pointed out.

Nonetheless, following a full review by the MHRA’s inspection team and assessors, the agency concluded that the data-integrity issues did not invalidate the results of the affected clinical trials.

“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,” commented Gerald Heddell, MHRA director of inspection, enforcement and standards.

“This conviction sends a message that we will not hesitate to prosecute those whose actions have the potential to harm public health.”

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