A Cambridgeshire medical researcher has become the first person to be prosecuted under the UK’s Good Laboratory Practice Regulations after he altered pre-clinical trial data.
Steven Eaton changed analytical data or provided false results that were then used to determine the concentration of medicine that could be given to clinical trial subjects.
Eaton, who worked for Aptuit at the time, was yesterday sentenced to three months in jail following a case that began when the US drug development and discovery company informed the MHRA that serious data irregularities had been identified.
The UK medicines regulator’s subsequent investigation concluded Eaton had selectively reported analytical data over a number of years, dating back to 2003.
“During this period he selectively reported data which 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 in fact it had failed,” the MHRA said in a statement.
As a result hundreds of safety studies had to be checked, significantly delaying the development of a number of new medicines at considerable cost to the study sponsors.
However, the MHRA’s inspection team and assessors ultimately decided the data integrity issues did not invalidate the results of the affected clinical trials.
Gerald Heddell, MHRA director of inspection, enforcement and standards, said: “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.”
Aptuit was quick to distance itself from Eaton, noting that his actions resulted in immediate disciplinary procedures and a “prompt departure from Aptuit’s employment” more than four years ago.
A statement from the company also drew attention to the 2011 closure of its Riccarton facility in Scotland, where Eaton worked, although Atuit acknowledged it had exited the site for business reasons unconnected with the MHRA investigation.